Therapeutic Goods Regulations 1990

These Regulations are the Therapeutic Goods Regulations 1990.

In these Regulations, unless the contrary intention appears:

active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.

AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.

analysis includes examination and testing.

antiseptic means a substance:

(a) that is recommended by its manufacturer for:

(i) dermal application; or

(ii) application to the mucous membranes of a person or an animal:

(A) to kill micro organisms; or

(B) to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and

(b) that is not represented to be suitable for internal use.

ASMI means Australian Self‑Medication Industry Limited (ACN 607 233 116).

authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.

Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.

Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.

Note 1: The Australian Approved Names List includes:

(a) Australian Approved Names—Chemicals List; and

(b) Australian Approved Names—Biological Lists; and

Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Medicines.

biological medicine means:

(a) a medicine (other than an antibiotic) that is:

(i) a vaccine, a peptide, a protein or polysaccharide‑based; and

(ii) derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and

(iii) of a kind specified in item 1 of Part 1 of Schedule 10; or

(b) a medicine that is a human blood product of a kind mentioned in Appendix A in Part 5 of the Poisons Standard.

C1 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C1 (section 23) application has the meaning given by Part 1 of Schedule 9.

C2 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C2 (section 23) application has the meaning given by Part 1 of Schedule 9.

C3 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C3 (section 23) application has the meaning given by Part 1 of Schedule 9.

C4 (section 9D) application has the meaning given by Part 1 of Schedule 9.

C4 (section 23) application has the meaning given by Part 1 of Schedule 9.

changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.

CHCA means the Complementary Healthcare Council of Australia.

Class 1 biological means a biological that is mentioned in Schedule 16 as a Class 1 biological.

Note: At the time these Regulations commenced, there were no Class 1 biologicals.

Class 1 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class 2 biological means a biological:

(a) that:

(i) has been subjected to only minimal manipulation; and

(ii) is only for homologous use; and

(iii) is not mentioned in Schedule 16 as a Class 1, 3 or 4 biological; or

(b) that is mentioned in Schedule 16 as a Class 2 biological.

Class 2 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class 3 biological means a biological:

(a) that is not a Class 1, 2 or 4 biological; or

(b) that is mentioned in Schedule 16 as a Class 3 biological.

Class 3 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class III medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

Class 4 biological means a biological that is mentioned in Schedule 16 as a Class 4 biological.

Class 4 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.

designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.

designated orphan drug means a medicine in relation to which a designation under regulation 16J is in force.

designated therapeutic goods means therapeutic goods other than:

(a) therapeutic devices; and

(b) goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of that standard; and

(d) biologicals.

disinfectant means a substance:

(a) that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and

(b) that is not represented by the manufacturer to be suitable for internal use.

expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.

Finance Minister means the Minister who administers the Public Governance, Performance and Accountability Act 2013.

fungicide means a chemical agent that kills a fungus or spores of a fungus.

generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):

(a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and

(b) has the same pharmaceutical form; and

(d) has the same safety and efficacy properties.

gene therapy means the in vivo transfer of DNA or RNA into the cells of human recipients.

herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):

(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and

(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.

high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.

homoeopathic preparation means a preparation:

(a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and

(b) prepared according to the practices of homoeopathic pharmacy using the methods of:

(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or

(ii) serial trituration in lactose.

homologous use: see regulation 3B.

hospital grade disinfectant means a disinfectant that is represented to be suitable for therapeutic use:

(a) in premises used for:

(i) the investigation or treatment of a disease, ailment or injury; or

(ii) procedures that are carried out involving the penetration of the human skin; or

(b) in connection with:

(i) the business of beauty therapy or hairdressing; or

(ii) the practice of podiatry;

but does not include:

(d) a sanitary fluid; or

(e) a sanitary powder; or

(f) a sanitiser.

household grade disinfectant means a disinfectant that is not:

(a) an antibacterial clothes preparation; or

(b) a hospital grade disinfectant; or

(d) a sanitary powder; or

(e) a sanitiser.

immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.

IN1 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

IN2 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:

(a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and

(b) an independent evaluation of the quality of the ingredient.

IN3 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:

(a) an evaluation of the quality of an ingredient based on:

(i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or

(ii) a monograph contained in a default standard; and

(b) an independent evaluation of the safety of the ingredient.

IN4 application means an application made under subsection 26BE(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

in‑house IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

IVD device means an IVD medical device:

(a) that is:

(i) a Class 1 IVD medical device; or

(ii) a Class 2 IVD medical device; or

(iii) a Class 3 IVD medical device; or

(iv) a Class 4 IVD medical device; and

(b) that is not an in‑house IVD medical device.

IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

joint replacement medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.

L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).

L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:

(a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:

(i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and

(ii) has the same pharmaceutical form; and

(iii) is bioequivalent; and

(iv) has the same safety and efficacy properties; or

(b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:

(a) either:

(i) the application requires an independent evaluation of the efficacy of the medicine; or

(ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and

(b) the application is not an L(A)1 application or an L(A)2 application.

minimal manipulation: see regulation 3B.

mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.

N1 application has the meaning given by Part 1 of Schedule 9.

N2 application has the meaning given by Part 1 of Schedule 9.

N3 application has the meaning given by Part 1 of Schedule 9.

N4 application has the meaning given by Part 1 of Schedule 9.

N5 application has the meaning given by Part 1 of Schedule 9.

new dosage form medicine means a medicine that:

(a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and

(b) has an indication in common with that other medicine; and

new indications medicine means a prescription medicine that:

(a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and

(b) does not have the same indications as that other medicine.

new prescription medicine means a prescription medicine that contains:

(a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or

(b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.

NFAA means the Nutritional Foods Association of Australia.

nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:

(a) a standard applicable to the biological; or

(b) any manufacturing requirements under the Act for the biological.

official analyst means a person approved by the Secretary under regulation 25.

open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.

Note: For container, see Act, subs 3(1).

original cells or tissues: see regulation 3B.

OTC medicine means therapeutic goods mentioned in Part 3 of Schedule 10.

pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.

Poisons Standard has the same meaning as current Poisons Standard.

Practice Guidelines has the meaning given by paragraph 12AB(2)(a).

principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.

quarter means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year.

RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).

RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.

RCM3 application means an application made under section 23 of the Act to register a complementary medicine, if:

(a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or

(b) the application requires an independent evaluation of one of the following:

(i) the safety of the medicine;

(ii) the quality of the medicine;

(iii) the efficacy of the medicine.

RCM4 application means an application made under section 23 of the Act to register a complementary medicine, if:

(a) the application requires an independent evaluation of 2 of the following:

(i) the safety of the medicine;

(ii) the quality of the medicine;

(iii) the efficacy of the medicine; or

(b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or

(i) an extension of indications of the medicine;

(ii) new directions for use of the medicine;

(iii) an increase in the target population for the medicine.

RCM5 application means an application made under section 23 of the Act to register a complementary medicine, if:

(a) either:

(i) the application requires an independent evaluation of the safety, quality and efficacy of the medicine; or

(ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and

(b) the application is not an RCM1 application, an RCM2 application, an RCM3 application or an RCM4 application.

RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.

RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

(a) the application is for a change to the entry of a registered complementary medicine (the existing medicine), the effect of which (if approved) would result in the medicine becoming separate and distinct for the purposes of Part 3‑2 of the Act; and

(b) the change is of a kind specified in the changes table as an RCMC1 (section 23) level change; and

(c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.

RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

(b) the change is of a kind specified in the changes table as an RCMC2 (section 23) level change; and

(c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.

RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

(b) the change is of a kind specified in the changes table as an RCMC3 (section 23) level change; and

(c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.

RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:

(b) the change is of a kind specified in the changes table as an RCMC4 (section 23) level change; and

(c) the new medicine, if registered would form part of the same gazetted therapeutic goods group as the existing medicine.

Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.

sample includes part of a sample.

serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:

(a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or

(b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.

specialist has the same meaning as in the Health Insurance Act 1973.

sporicide means a chemical agent that:

(a) kills bacterial spores; and

(b) has the potential to act as a sterilising agent after prolonged contact with an inanimate object.

Standard AS/NZS means a joint Australian and New Zealand Standard published by, or on behalf of, Standards Australia and the body known as Standards New Zealand.

Note: Section 2B of the Acts Interpretation Act 1901 defines Standards Australia.

sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.

submission has the meaning given by subclause 1(2) in Part 1 of Schedule 9.

TGA notifications process guidance document means Version 3.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 1 July 2018).

Note: The TGA notifications process guidance document could in 2018 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).

the Act means the Therapeutic Goods Act 1989.

Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration.

therapeutic goods (priority applicant) determination has the meaning given by subsection 25AAA(2) of the Act.

trade name, for therapeutic goods of a particular kind, means the commercial name:

(a) given to goods of that kind by the manufacturer; and

(b) under which the goods are supplied.

traditional use, for a designated active ingredient, means use of the designated active ingredient that:

(a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and

(b) accords with well‑established procedures of preparation, application and dosage.

tuberculocide means a chemical agent that kills Mycobacterium tuberculosis and related acid‑fast bacteria.

turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).

unused emergency biological means a biological to which section 32CG of the Act applies.

unused emergency goods means goods to which section 30G of the Act applies.

virucide means a chemical agent that renders a virus non‑infective.

Note: For the definitions of the following terms, see subsection 3(1) of the Act:

 medicine

 poison

 product information

 Secretary.

2A Authorised officers

The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:

(a) an officer of the Department, of another Department or of an authority of the Commonwealth;

(b) an officer of:

(i) a Department of State of a State; or

(ii) a Department or administrative unit of the Public Service of a Territory; or

(iii) an authority of a State or of a Territory;

being a Department, unit or authority that has functions relating to health matters.

3 Corresponding State law

(1) In this regulation:

the Regulations means:

(a) the Therapeutic Goods Regulations 1990; and

(b) the Therapeutic Goods (Medical Devices) Regulations 2002.

(3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:

(a) the Poisons and Therapeutic Goods Act 1966 (NSW);

(b) the Poisons and Therapeutic Goods Regulation 2008 (NSW);

(ba) the Therapeutic Goods (Victoria) Act 2010 (Vic);

(bb) the Controlled Substances Act 1984 (SA);

(bc) the Controlled Substances (Poisons) Regulations 2011 (SA);

(d) the Therapeutic Goods Regulations 2002 (Tas);

(e) Medicines, Poisons and Therapeutic Goods Act 2008 (ACT);

(f) Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT);

(g) Medicines, Poisons and Therapeutic Goods Act (NT);

(h) Medicines, Poisons and Therapeutic Goods Regulations (NT).

3AA Unacceptable presentation of therapeutic goods—prescribed class of medicine

For paragraph 3(5)(ca) of the Act, a prescribed class of medicine is medicine for supply in Australia that is not:

(a) a product of a kind mentioned in Part 1 of Schedule 10; or

(b) a medicine that satisfies the following requirements:

(i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;

(ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);

(iii) the medicine complies with the terms of the Secretary’s consent mentioned in subparagraph (ii); or

(i) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act;

(ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or

(d) a medicine that satisfies the following requirements:

(i) the medicine only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act;

(ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.

3A Unacceptable presentations

(1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.

(2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.

3B Definitions relating to goods comprising etc. human cells and tissues

(1) This regulation applies to goods that comprise, contain, or are derived from human cells or tissues.

(2) The human cells or tissues are the original cells or tissues.

(3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.

(4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.

Part 2—Advertisements

Division 1—Application of Part

4 Application of Part 2

(1) This Part applies to advertisements to which Part 5‑1 of the Act applies.

(2) For subsection 42AA(2) of the Act, the bodies mentioned in Schedule 1 are prescribed.

4A Interpretation

A term used in this Part and in Part 5‑1 of the Act has the same meaning in this Part as it has in Part 5‑1 of the Act.

Note: See section 42B of the Act for definitions of terms used in Part 5‑1 of the Act.

Division 2—Advertisements for which approval is needed

5B Interpretation

In this Division:

applicant means an applicant for approval of an advertisement.

approval holder, in relation to an approved advertisement, means the person to whom notice of approval of the advertisement was given.

withdraw, in relation to an approved advertisement, includes withdrawal by any delegate under subregulation 5Q(2) or (3), whether or not that delegate gave the approval and, in the case of an approval given by the NFAA, includes a withdrawal by the CHCA.

5BA Means that are not broadcast media

For the definition of broadcast media in section 42B of the Act, in relation to an advertisement to which this Division applies, each of the following means is declared to be an exempted means:

(a) the Internet;

(b) electronic mail;

(i) by being targeted to special interest groups; or

(ii) by being intended only for limited locations (for example, arenas or business premises); or

(iii) by being provided during a limited period or to cover a special event; or

(iv) because it provides programs of limited appeal; or

(v) for any other reason;

(d) short message service (SMS), being a system enabling the transmission of short text messages from a digital mobile telephone to another digital mobile telephone;

(e) multimedia messaging service (MMS), being a system enabling the transmission of visual communication, voice communication or electronic mail from a digital mobile telephone to:

(i) another digital mobile telephone; or

(ii) an electronic mail address.

5C Application of Division

(1) This Division applies to advertisements for designated therapeutic goods published or inserted, or intended to be published or inserted, for valuable consideration, in specified media.

(2) However, this Division does not apply to an advertisement that consists only of one or more of the following:

(a) the brand name of the goods;

(b) the price of the goods;

(d) a photographic or other reproduction of the goods that does not contain any claim for therapeutic use in relation to the goods;

(e) the locations or times at which the goods are offered for sale;

(f) any other information reasonably necessary to identify the person offering the goods for sale.

5F Applications for approval of advertisements

An application for approval of an advertisement must be:

(a) made to the Secretary in writing, in a form approved by the Secretary; and

(b) signed by or on behalf of the applicant.

5G Approval of advertisements

(1) If an application for approval of an advertisement is made and the prescribed fee is paid, the Secretary must approve the advertisement if the Secretary is satisfied that it:

(a) complies with the Therapeutic Goods Advertising Code; and

(b) does not contain a prohibited representation (whether in express terms or by necessary implication) about the goods; and

(d) does not contain an unacceptable presentation of the goods within the meaning of regulation 3A; and

(e) does not contain a restricted representation about the goods the use of which has not been approved under section 42DF of the Act or permitted under subsection 42DK(1) of the Act.

(3) Otherwise, the Secretary must refuse to approve the advertisement.

(4) An approval may be subject to conditions imposed by the Secretary.

5H Notice of approval or refusal to approve an advertisement

(1) The Secretary must give written notice to the applicant of the approval of, or of the refusal to approve, an advertisement.

(2) If written notice is not given to the applicant within 60 days after the day on which the application was made, or within such longer period as may be agreed in writing between the applicant and the Secretary, the Secretary is taken to have approved the advertisement at the end of the period.

(3) If an approval is subject to conditions, the conditions must be set out in the notice.

(4) A notice of refusal to approve an advertisement must:

(a) give the Secretary’s reasons for the refusal; and

(b) inform the applicant of the applicant’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

5J Distinguishing numbers for approved advertisements

(1) The Secretary must allocate a distinguishing number (the approval number) to each approved advertisement.

(2) The Secretary must inform the applicant of the approval number at the time of giving notice of the approval of the advertisement.

(3) Unless the approval of the advertisement is withdrawn, an approval number expires at the end of 2 years from the date on which it is allocated.

5K Variation of conditions of approval

(1) The Secretary, by written notice to an approval holder, may vary any condition of approval of an approved advertisement.

(2) The notice must:

(a) give the Secretary’s reasons for the variation; and

(b) inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

5L Withdrawal of approval

(1) The Secretary, by written notice to an approval holder, may withdraw the approval of an approved advertisement if the Secretary is satisfied that:

(a) information given by the applicant in the application was false or incorrect and the Secretary or the Minister relied on the information in deciding to approve the advertisement; or

(b) a person has contravened section 42C of the Act in relation to the advertisement; or

(d) the advertisement does not comply with the Therapeutic Goods Advertising Code.

(3) The notice under subregulation (1) must:

(a) give the Secretary’s reasons for the decision; and

(b) inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

5M Review by Minister of decisions of the Secretary

(1) An applicant or approval holder who is dissatisfied with a decision of the Secretary under regulation 5G, 5K or 5L may request the Minister, in writing, to review the decision.

(2) The request must be made within 30 days after notice of the decision is given to the applicant or approval holder.

(2A) The request may be accompanied by information in support of the request.

(4) The Minister must reconsider the decision of the Secretary as soon as practicable after receiving a request, and may:

(a) confirm the Secretary’s decision; or

(b) revoke the Secretary’s decision and make a decision (including a decision to impose conditions) in substitution for the Secretary’s decision; or

(c) if the decision is a decision of the Secretary under regulation 5K or 5L—revoke the decision without making a decision in substitution for the Secretary’s decision.

(4A) In making a decision under subregulation (4), the Minister:

(a) must take into account any information referred to in subregulation (2A); and

(b) must not take into account any other information provided by, or on behalf of, the applicant or approval holder after the making of the request, other than information provided in response to a request from the Minister.

(4B) Paragraph (4A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the decision of the Secretary.

(6) Until a decision is made by the Minister, the making of a request does not affect the operation of the Secretary’s decision.

5N Notice of Minister’s decisions

(1) The Minister must give written notice to the applicant or approval holder of the decision of the Minister under regulation 5M.

(3) If the Minister’s decision is to approve an advertisement subject to conditions, the conditions must be set out in the notice.

(4) The notice must:

(a) give the Minister’s reasons for the decision; and

(b) inform the applicant or approval holder of the right of the applicant or approval holder to apply to the Administrative Appeals Tribunal under regulation 5P for a review of the Minister’s decision.

5P Review by Tribunal of decisions of the Minister

An application may be made to the Administrative Appeals Tribunal for a review of a decision of the Minister under regulation 5M.

5Q Delegations

(1) The Minister may delegate, in writing, a power or function of the Minister under regulation 5M or 5N to an officer of the Department.

(2) The Secretary may delegate, in writing, the Secretary’s power under regulation 5G to:

(a) an officer of the Department; or

(b) a medical practitioner registered in a State or internal Territory who is employed by the government of a State or Territory.

(3) The Secretary may delegate to the CHCA the Secretary’s power under regulation 5G in relation to an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be published or used in specified media of the kind mentioned in paragraph (a), (c) or (d) of the definition of specified media in section 42B of the Act.

(4) The Secretary may delegate to the ASMI the Secretary’s power under regulation 5G in relation to:

(a) an advertisement about designated therapeutic goods that are complementary medicines if the advertisement is to be broadcast in broadcast media; and

(b) an advertisement about designated therapeutic goods that are not complementary medicines if the advertisement is to be published or broadcast in specified media.

(5) The Secretary may delegate the Secretary’s power under regulation 5K or 5L in relation to a class of advertisements to a person if the Secretary has delegated to the person the Secretary’s power under regulation 5G for the same class of advertisements.

(6) A person exercising a power under a delegation under this regulation must comply with any conditions imposed or directions given by the Minister or Secretary, as the case requires.

Division 3—General provisions about advertising therapeutic goods

6AA Prescribed committees

For paragraph 42DF(4)(b) of the Act, the following committees are prescribed:

(a) Advisory Committee on Medicines;

(b) Advisory Committee on Complementary Medicines;

(d) Advisory Committee on Vaccines.

6B Prohibited and required representations

(1) For subsection 42DJ(1) of the Act, the following representations are prohibited representations:

(a) the representations in column 2 of an item in Part 1 of Schedule 2 about therapeutic goods in column 3 of that item;

(b) the representations described in section 30 of the Therapeutic Goods Advertising Code.

(2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.

7 Prescribed goods for advertising offence and civil penalty

For the purposes of subsections 42DL(12) and 42DLB(9) of the Act, the therapeutic goods are the following:

(a) therapeutic goods that are the subject of an approval or authority under section 19 of the Act;

(b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;

(d) therapeutic goods specified in item 1 of Schedule 5;

(e) therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A;

(f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;

(g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;

(h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;

(i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act.

7A Publisher exception for civil penalty provisions

For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.

Division 4—Generic information about ingredients or components of therapeutic goods

8 Compliance with the Code

For section 42DO of the Act, sections 9, 10, 15, 16, 18, 19 and 21 of the Therapeutic Goods Advertising Code are prescribed.

Note: The application of those sections is affected by section 6 of the Code.

Part 2A—Patient information

9A Information about certain therapeutic goods to be supplied

(1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 12.

Penalty: 10 penalty units.

Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.

(1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.

Note: For strict liability, see section 6.1 of the Criminal Code.

(1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.

Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).

(1A) The sponsor of therapeutic goods that are:

(a) specified in Schedule 3 of the Poisons Standard; and

(b) are approved for registration on or after 4 July 1995;

must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 13.

Penalty: 10 penalty units.

(1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).

Note: For strict liability, see section 6.1 of the Criminal Code.

(2) For the purposes of subregulation (1) or (1A), information must be provided:

(a) in the primary pack in which the therapeutic goods are supplied; or

(b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.

9B Information about therapeutic goods manufactured using human embryos

(1) A sponsor of therapeutic goods (other than medical devices) commits an offence if:

(a) the sponsor supplies the goods on or after 1 July 2004; and

(b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and

(d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and

(e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.

Penalty: 10 penalty units.

(2) Strict liability applies to the physical elements mentioned in paragraphs (1)(c), (d) and (e).

(3) The information in relation to the therapeutic goods must be included in:

(a) the patient information document required under regulation 9A; and

(b) the product information in relation to the goods.

(4) In this regulation:

human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.

human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.

(5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.

Part 2C—Australian Register of Therapeutic Goods

Division 2C.1—Registered and listed therapeutic goods

10 Goods to be included in parts of the Register (Act s 9A)

For paragraph 9A(4)(a) of the Act:

(a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and

(aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and

(b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.

10AAA Variation of entries in Register—registered complementary medicines and registered OTC medicines

Kinds of variations

(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.

Conditions

(2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:

(a) the variation reflects a change that will be made to, or in relation to, the medicine;

(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.

Kinds of variations—registered complementary medicines and registered OTC medicines
Column 1	Column 2	Column 3
Item	Variation	Code
1	The addition of a flash including the term “new” or “value pack” to a label or package insert for the medicine	LLN
2	If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert for the medicine	LSP
3	A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive	PSC
4	A decrease in the shelf life of the medicine included in a label or package insert for the medicine	PSR
5	A reduction or removal of an overage for an active ingredient of the medicine	AOV
6	A change to the type of starch (if any) used as an excipient in the medicine	EST
7	Either of the following: (a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard; (b) if the specifications for the medicine include in‑house tests—the replacement of those tests with a default standard	QFP
8	Either of the following: (a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard; (b) if the specifications for the starting materials of the medicine include in‑house tests—the replacement of those tests with a default standard	QSP
9	If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made: (a) if the material is polyvinyl chloride—a change to: (i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or (ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene; (b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene; (c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability	KBL
10	If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made: (a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass; (b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass; (c) if the material is polyethylene: (i) an increase in the material’s density; or (ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre; (d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre; (e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre	KBT
11	A change to the closure system for the medicine, unless: (a) the closure system also functions as a metering component of the medicine; or (b) the change involves a change to the pump, or components of the pump, of a metered‑dose aerosol	KCL
12	If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack	KRR
13	If the medicine is non‑sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine	AMS
14	If the medicine is non‑sterile, the manufacture of the medicine at an additional site	MMA
15	The cessation of the manufacture of the medicine by a manufacturer	MMD
16	A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine	MSD
17	A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine	LFT
18	Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for: (a) use of the medicine; or (b) use of a measuring device; or (c) use of an applicator	RGN
19	A change to the location of a graphic on the panel of a label for the medicine if: (a) there is no change to the size, shape or colour of the graphic; and (b) the change does not involve reformatting text	LGM
20	If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine	PSN
21	If the medicine is in a liquid or semi‑solid dosage form, the addition of a new pack size that is within the pack size range for the medicine	PLN
22	The deletion of a pack size for the medicine	PSD
23	If the medicine is sterile: (a) the addition of a manufacturer of the medicine for the performance of any of the following steps: (i) release for supply; (ii) secondary packaging; (iii) chemical, physical or microbial testing; or (b) the inclusion of the performance of any of the steps mentioned in paragraph (a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine	MSS
24	If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if: (a) other means of accurately measuring the dose are readily available; and (b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and (c) there are no changes to the directions for use of the medicine	KMO

10AAB Variation of entries in Register—prescription medicines other than biological medicines

Kinds of variations

(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.

Conditions

(a) the variation reflects a change that will be made to, or in relation to, the medicine;

(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.

Kinds of variations—prescription medicines other than biological medicines
Column 1	Column 2	Column 3
Item	Variation	Code
1	A change to the container or closure system used to store a non‑sterile active pharmaceutical ingredient of the medicine	ACCS
2	A change to the synthesis of an active pharmaceutical ingredient of the medicine if: (a) the ingredient is not a synthetic polypeptide; and (b) the ingredient is not prepared by fermentation; and (c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and (d) the Directorate: (i) has issued a revised certificate of suitability in relation to the ingredient; or (ii) has declared that the ingredient does not require a revised certificate of suitability	ACEP
3	A change to the size of a manufacturing batch of a non‑sterile active pharmaceutical ingredient, or a non‑sterile intermediate of such an ingredient, of the medicine	AMBS
4	The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site	AMCS
5	The introduction, revision or discontinuation of: (a) an in‑process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or (b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate	AMIT
7	If an active pharmaceutical ingredient of the medicine is manufactured by multi‑step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation): (a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or (b) the manufacture of such an intermediate at an additional site	AMMF
8	The transfer of the manufacture of a non‑sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if: (a) the ingredient is not prepared by fermentation; and (b) the ingredient is a pure chemical entity; and (c) the ingredient is prepared: (i) by chemical synthesis; or (ii) through isolation from a natural source	AMTA
9	A change to a non‑biological method used for assaying or residual solvent testing (including testing for water) any of the following: (a) an active pharmaceutical ingredient of the medicine; (b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient	ASAM
10	Either of the following: (a) a shortening of the re‑test period for an active pharmaceutical ingredient of the medicine; (b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine	ASDR
11	A change to an identification test used in relation to: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient	ASID
12	A change to the specifications for: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient; if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent	ASNL
13	A change, resulting from the addition of a new test and its associated limits, to the specifications for: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient	ASNT
14	A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine	ASPT
15	A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form	DMBS
16	A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) semi‑solid or liquid; and (b) not a modified release dosage form	DMEL
17	A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) nasal or oral inhalation; and (b) not a modified release dosage form	DMEO
18	A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) solid; and (b) not a modified release dosage form	DMES
19	The introduction, revision or discontinuation of: (a) an in‑process control test applied during the manufacture of the medicine; or (b) a limit associated with an in‑process control test applied during the manufacture of the medicine	DMIT
20	A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form	DMRO
21	A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) sterile; and (b) not a modified release dosage form	DMSE
22	The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site	DMDM
23	Any of the following: (a) if the dosage form of the medicine is sterile: (i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or (ii) the performance of those things at an additional site; (b) if the dosage form of the medicine is not sterile: (i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or (ii) the performance of those things at an additional site	DMPL
24	If the dosage form of the medicine is: (a) non‑sterile semi‑solid or non‑sterile liquid; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site	DMSL
25	If the dosage form of the medicine is: (a) non‑sterile oral, or non‑sterile nasal, inhalation; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site	DMSO
26	If the dosage form of the medicine is: (a) non‑sterile solid; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site	DMSS
27	Either of the following: (a) a change to the location of a site where either of the following are performed in relation to the medicine: (i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing); (ii) release for supply; (b) the performance of either of the following in relation to the medicine at an additional site: (i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing); (ii) release for supply	DMTR
28	A change to a non‑biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical	DSAM
29	A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine	DSID
30	A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine	DSIP
31	A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent	DSNL
32	The addition of a new test and limits associated with the test to the specifications for the medicine	DSNT
33	A minor change to a method used to test physiochemical parameters of the medicine	DSPL
34	A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine	DSPT
35	A change to a method used to test the sterility of the medicine	DSST
36	If: (a) the medicine is not administered by the parenteral, ophthalmic or intra‑tracheal route; and (b) the source of an excipient in the medicine is Category IC ruminant tissue; any of the following: (c) a change in the source of the excipient to a non‑animal source; (d) a change in the manufacturing process of the excipient; (e) a change to the location of a manufacturing site	EMRS
37	A change to a method used to assay an excipient in the medicine	ESAM
38	A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient	ESIP
39	A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent	ESNL
40	A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine	ESNT
41	A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine	ESPT
42	A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine	CCCA
43	A change to the size or shape of a container or closure system for the medicine if the medicine is non‑sterile	CCSS
44	Any of the following changes to the specifications for a container or closure system for the medicine: (a) the inclusion of a new test; (b) making a limit more stringent; (c) the deletion of a test procedure; (d) a minor change to a test method	CCST
45	If the dosage form of the medicine is non‑sterile, and solid or semi‑solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine	CMDT
46	An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is: (a) non‑sterile; and (b) solid, semi‑solid, semi‑liquid or liquid	CMIT
47	A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection 10(1) of the Act that applies to the medicine)	LQAE
48	A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation	LQAT
49	A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large‑volume injection	LQHI
50	A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch	LQRT
51	A change to a label for the medicine to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous	LWAH
52	A change to a label for the medicine to include a warning or cautionary statement if: (a) the Secretary, under subsection 9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and (b) the Secretary, under subsection 25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection 25AA(1) of the Act to add that warning or cautionary statement	LWSR
53	A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine	ASPC
54	A minor change to: (a) the manufacture of an active pharmaceutical ingredient of the medicine; or (b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine; if the change does not affect any step taken to sterilise the ingredient or intermediate	AMMC
55	A change to a label for the medicine that deletes text from side or rear panels if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine	LPDR
56	A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine	LPCS
57	A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery	LPCL
58	A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form	LPDG
59	A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form	LPCP
60	A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form	LPIA
61	A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine	LPOP
62	A change to a label for the medicine as a consequence of: (a) a variation, under subsection 9D(3) of the Act, of the entry in the Register that relates to the medicine; or (b) a condition imposed, under subsection 28(3) of the Act, on the listing or registration of the medicine	LOCI
63	A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”	LPRP
64	A change to a label for the medicine to include a QR code, if the link is: (a) to a website owned by the person in relation to whom the medicine is included in the Register; and (b) to information that is non‑promotional	LPQR
65	A change to a label for the medicine to include information about a patient support program	LPPS

10AAC Variation of entries in Register—biological medicines

Kinds of variations

(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.

Conditions

(a) the variation reflects a change that will be made to, or in relation to, the medicine;

(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.

Kinds of variations—biological medicines
Column 1	Column 2	Column 3
Item	Variation	Code
1	A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent	PSNL
2	A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine	PSQC
3	The release for supply of the medicine at an additional site	PMRS
4	A reduction in the column life of columns used in the purification process for the medicine	PPCR
5	A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma‑derived	PPHR
6	A change to the manufacturer of a filter used in a fermentation process for the medicine	FPFM
7	The introduction of more stringent internal controls on a fermentation process for the medicine	FPNC
8	A reduction in the time required to culture and harvest the cell line for the medicine	FPRP
9	A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine	PFCR
10	The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine	PFSC
11	A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent	ISNL
12	A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the drug substance or excipient; or (b) an order in force under subsection 10(1) of the Act that applies to the drug substance or excipient	ISPT
13	A change to a method used for testing a drug substance or excipient of the medicine if: (a) the change is to adopt a method in a default standard; and (b) the test is not for viral safety	ISAM
14	A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard	PSNT
15	A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine	PSPT
16	A minor change to a physicochemical test method used for testing the medicine	PMPL
17	The replacement of an in‑house reference standard with another if the protocol and acceptance criteria for establishing a replacement in‑house reference standard have been approved by the Therapeutic Goods Administration	IRSR
18	A change to a label for the medicine that deletes text from a side or rear panel if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine	LPDR
19	A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine	LPCS
20	A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery	LPCL
21	A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form	LPDG
22	A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form	LPCP
23	A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form	LPIA
24	A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine	LPOP
25	A reduction in the shelf life of the drug substance of the medicine	ASRS
26	A reduction in the shelf life of the medicine	PSLD
27	The introduction of anti‑tamper packaging if the packaging material is not in contact with the medicine	PPAT
28	Either or both of the following changes to the manufacture of the medicine: (a) removal of a temperature excursion; (b) reduction in the time spent out of refrigeration or freezer storage	PSET
29	The addition of a storage condition for the medicine	PSAR
30	A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed	OAMS

10AAD Variation of entries in Register—biologicals

Kinds of variations

(1) For the purposes of paragraph 9D(3AC)(b) of the Act, a variation:

(a) of an entry in the Register that relates to a biological; and

(b) that is listed in the table in subregulation (2);

is specified.

Conditions

(2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:

(a) the variation reflects a change that will be made to, or in relation to, the biological;

(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.

Kinds of variations—biologicals
Item	Column 1 Variation	Column 2 Code
1	A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the biological; or (b) an order in force under subsection 10(1) of the Act that applies to the biological	PT
2	A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent	DS
3	A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease	TK
4	A change to a critical material used in the manufacture of the biological if: (a) the critical parameters for the changed material are equivalent or of greater quality; and (b) the material is not of human or animal origin; and (c) the material is not an excipient; and (d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material	SM
5	The introduction of more stringent limits to an in‑process control test applied during the manufacture of the biological	MI
6	The removal of a product if the biological is a Class 2 biological	BR
7	The addition of a site at which secondary packaging or storage of the biological is performed	MA
8	A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological: (a) quality control testing; (b) infectious disease testing	MT
9	The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site	MR
10	The introduction of more stringent limits to a release test applied during the manufacture of the biological	BS
11	A reduction in the shelf life or shipping timeframe of the biological	BT
12	A change to the label or supporting documentation for the biological to: (a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or (b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient	LC

10AA Prescribed requests for variations of entries in Register

(1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:

(a) the definition of C1 (section 9D) application;

(b) the definition of C2 (section 9D) application;

(d) the definition of C4 (section 9D) application;

(e) the definition of RCMC1 (section 9D) request;

(f) the definition of RCMC2 (section 9D) request;

(g) the definition of RCMC3 (section 9D) request;

(h) the definition of RCMC4 (section 9D) request.

(2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.

10AB Change of person in whose name goods are listed or registered

Application

(1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.

Death of person

(2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

(3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

(4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

(5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

(a) is taken to be the person in relation to whom the therapeutic goods are registered or listed; and

(b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.

Secretary may request further information

(6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.

Secretary must amend the Register and provide new certificate

(7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:

(a) amend the Register accordingly; and

(b) as soon as practicable after amending the Register:

(i) inform the person of the amendment; and

(ii) make available to the person a certificate of registration or listing.

10AC Change of name of person

Application

(1) This regulation applies in relation to a person in relation to whom therapeutic goods are registered or listed.

Change of name of person

(2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

Secretary may request further information

(3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

Secretary must amend the Register and provide new certificate

(4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:

(a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and

(b) as soon as practicable after entering the new name:

(i) inform the person that the new name has been entered in the Register; and

(ii) make available to the person a new certificate of registration or listing.

10B Transfers within the Register

(1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:

(a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or

(b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.

(2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:

(a) to transfer the entry for the goods to the part of the Register for listed goods; or

(b) to retain the entry in the part of the Register for registered goods.

(3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.

(4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:

(a) listed goods; or

(b) registered goods; or

(5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.

(6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:

(a) are included in the Register as a medical device under Chapter 4 of the Act; and

(b) cease to be a medical device because of a declaration under subsection 41BD(3) of the Act; and

(7) An application under subregulation (1), (3), (4) or (6) must be made:

(a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or

(b) in any other case—within 15 months after the day when the goods:

(i) became subject to inclusion in the part of the Register for registered goods; or

(ii) were specified by the Secretary to be a biological under subsection 32A(2) of the Act.

Penalty: 5 penalty units.

(8) An offence under subregulation (7) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(9) In determining a period of notice for paragraph (7)(a), the Secretary must consider:

(a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and

(b) the reasons for the transfer in relation to the protection of the public.

(10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:

(a) expiry of the time for making the application under subregulation (7); or

(b) if an application is made—when the application is determined.

(11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.

10C Re‑assignment of registration or listing numbers

(1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.

(2) An application:

(a) must be made in writing to the Secretary and delivered to an office of the Department; and

(b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and

(3) The Secretary may assign to therapeutic goods that:

(a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and

(b) are not grouped therapeutic goods when:

(i) the application is decided; or

(ii) an order is made under section 16 of the Act in relation to the goods;

a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.

(4) The Secretary must assign to grouped therapeutic goods that:

(a) were in a gazetted therapeutic devices group or a gazetted therapeutic goods group when a registration or listing number was assigned, or last assigned, to the goods; and

(b) are in a gazetted therapeutic devices group, or a gazetted therapeutic goods group, other than a group referred to in paragraph (a), when:

(i) the application is decided; or

(ii) an order is made under section 16 of the Act in relation to the goods;

a registration or listing number that is not assigned to other therapeutic goods or grouped therapeutic goods.

(5) The Secretary must assign to therapeutic goods that:

(a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and

(b) are grouped therapeutic goods when:

(i) the application is decided; or

(ii) an order is made under section 16 of the Act in relation to the goods;

a registration or listing number in accordance with subregulation (6).

(6) The Secretary:

(a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and

(b) must assign to those goods a registration or listing number that:

(i) was assigned, or last assigned, to the goods; and

(ii) is nominated by the person in whose name the goods are registered or listed;

not being a registration or listing number that is assigned to other therapeutic goods or grouped therapeutic goods.

10D Notice of reassignment of registration or listing numbers

The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.

Division 2C.2—Medical devices included in the Register under Chapter 4

10E Goods to be included in part of the Register for medical devices (Act s 9A)

For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.

10F Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act

Application

(1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.

Death of person

(2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

(a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

(3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

(a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

(4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

(a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

(5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

(a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and

(b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.

Secretary may request further information

Secretary must amend the Register and provide new certificate

(a) amend the Register accordingly; and

(b) as soon as practicable after amending the Register:

(i) inform the person of the amendment; and

(ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.

10FA Change of name of person

Application

(1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.

Change of name of person

(2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

Secretary may request further information

(3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

Secretary must amend the Register and provide new certificate

(4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:

(a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

(b) as soon as practicable after entering the new name:

(i) inform the person that the new name has been entered in the Register; and

(ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.

Division 2C.3—Biologicals included in the Register

10G Goods to be included in the part of the Register for biologicals

For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.

10H Change of person for whom a biological is included in the Register under Part 3‑2A of the Act

Application

(1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.

Death of person

(2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:

(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person

(3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:

(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate

(4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:

(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business

(5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:

(a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

(b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.

Secretary may request further information

Secretary must amend the Register and provide new certificate

(7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:

(a) amend the Register accordingly; and

(b) as soon as practicable after amending the Register:

(i) inform the person of the amendment; and

(ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.

10HA Change of name of person

Application

(1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.

Change of name of person

(2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

Secretary may request further information

(3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

Secretary must amend the Register and provide new certificate

(a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and

(b) as soon as practicable after entering the new name:

(i) inform the person that the new name has been entered in the Register; and

(ii) make available to the person a new certificate of the inclusion of the biological in the Register under that Part.

10I Re‑assignment of biological numbers

(1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.

(2) The application:

(a) must be made in writing to the Secretary and delivered to an office of the Department; and

(b) must have with it written information in sufficient detail to allow the application to be properly considered.

(3) The Secretary may assign to the biological a biological number that is not assigned to another biological.

10J Notice of reassignment of biological numbers

The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.

Part 2D—Provisional determinations for medicine

10K Applications for provisional determinations

For the purposes of subsection 22C(1) of the Act, the kinds of medicine are the following:

(a) new prescription medicine;

(b) new indications medicine.

10L Provisional determinations

For the purposes of subsection 22D(2) of the Act, the criteria are all of the following:

(a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;

(b) either:

(i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or

(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;

(d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.

Part 3—Registration, inclusion, listing and exemption of therapeutic goods

11 Characteristics that separate and distinguish certain medicines from other therapeutic goods

(1) For paragraph 16(1A)(d) of the Act, different characteristics are:

(a) a different name; or

(b) different indications; or

(d) for medicines that contain any restricted ingredients:

(i) a different quantity of a restricted ingredient that is an excipient; or

(ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or

(iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.

(2) A substance is a restricted ingredient if:

(a) it is an ingredient in a relevant medicine; and

(b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:

(i) Schedule 4;

(ii) the Poisons Standard;

(iii) a condition imposed under section 28 of the Act;

(iv) a standard under section 10 of the Act;

(vi) any other provision in these Regulations or in the Act that deals with eligibility of medicines for listing.

(3) In this regulation:

relevant medicine means a medicine that is listable goods or listed goods and that is not an export only medicine.

11A Characteristics that separate and distinguish certain biologicals from other biologicals

(1) For section 32AB of the Act:

(a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:

(i) applicable standards;

(ii) intended clinical use;

(iii) principal manufacturer; and

(b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:

(i) product name;

(ii) dosage form;

(iii) formulation or composition;

(iv) therapeutic indication;

(v) type of container, regardless of container size;

(vi) principal manufacturer.

(1A) However, a biological is not separate and distinct from other biologicals under subregulation (1) if:

(a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and

(b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.

(2) In this regulation:

principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.

12 Exempt goods

(1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:

(a) Part 3‑2 (except sections 30EA, 31A and 31C to 31F);

(b) Division 4 of Part 3‑2A.

(2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:

(a) Part 3‑2 (except sections 30EA, 31A and 31C to 31F);

(b) Division 4 of Part 3‑2A.

(3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.

(4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.

12A Unapproved medicines and biological—exemption in life‑threatening cases

(1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in the 9th Schedule to the Poisons Standard, as in force from time to time, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).

(1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.

(2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:

(a) the medicine or biological is to be given to a person who satisfies the following criteria:

(i) the person is a Category A patient (as defined in subregulation (5)); and

(ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and

(iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and

(b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.

(2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

(3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.

Penalty: 10 penalty units.

(3A) An offence under subregulation (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) This regulation does not affect the operation of regulation 12.

(5) In this regulation:

Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.

informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.

12AAB Disposal of unused emergency goods and unused emergency biologicals

(1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.

(2) Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of unused emergency goods if:

(a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):

(i) registered goods or listed goods; or

(ii) exempt goods under section 18 of the Act; or

(iii) goods that are the subject of an approval or authority under section 19 of the Act; or

(iv) goods that are the subject of an approval under section 19A of the Act; and

(b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the goods.

(3) Nothing in this regulation or in Schedule 5B is taken to prevent a disposal of an unused emergency biological if:

(a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):

(i) included in the Register under Part 3‑2A of the Act; or

(ii) exempt under subsection 32CA(2) of the Act; or

(iii) the subject of an approval or authority under section 32CK or 32CM of the Act; or

(iv) the subject of an approval under section 32CO of the Act; and

(b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the biological.

12AA Applications for special and experimental uses

Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:

(a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and

(b) the name of, and the contact details for, the principal investigator for each trial; and

(c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and

(d) information about whether or not any conditions specified by the committee have been met.

12AB Goods imported etc for experimental uses

(1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.

(2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:

(a) a written assurance that clinical trials will be conducted in accordance with the Guidelines for Good Clinical Practice (the Practice Guidelines), as in force from time to time, published jointly by the International Conference on Harmonisation on Technical Requirements for Registration of Pharmaceuticals for Human Use and the Committee for Medicinal Products; and

(b) a written undertaking:

(i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and

(ii) allow an authorised officer to do the things mentioned in regulation 12AC.

12AC Powers of authorised officers in relation to goods imported etc for experimental uses

(1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB:

(a) enter the site of the trial; and

(b) search the site and any thing on the site; and

(c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and

(d) take photographs, make video recordings or make sketches of the site or any thing on the site; and

(e) inspect any book, record or document on the site that relates to the trial; and

(f) request the principal investigator to:

(i) answer any questions put by the authorised officer; and

(ii) produce any book, record or document requested by the authorised officer.

(2) An authorised officer is not entitled to do a thing mentioned in subregulation (1) if:

(a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and

(b) the authorised officer fails to comply with the request.

Note: For identity cards, see section 52 of the Act.

(3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.

(4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.

12AD Use of goods for experimental purposes—specified conditions

For subsections 19(4A) and 32CL(1) of the Act, the following conditions are specified:

(a) the use of therapeutic goods in a clinical trial must be in accordance with the Practice Guidelines;

(b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;

(c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;

(d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:

(i) the protocol mentioned in paragraph (b); or

(ii) any condition subject to which approval for the use was given.

12B Exemptions for certain uses—medicines and therapeutic devices

(1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.

(1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:

(a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and

(b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.

(2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.

(3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.

(4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a therapeutic device, or a class of therapeutic devices, may be supplied in accordance with an authority under subsection 19(5) of the Act are:

(a) that, in each case, the medical practitioner authorised under subsection 19(5) of the Act:

(i) is a specialist engaged in clinical practice at a hospital; and

(ii) is endorsed by the relevant ethics committee of the hospital; and

(b) that the authority states the particular therapeutic intervention, or class of therapeutic intervention, for which the medical practitioner may supply the therapeutic device or class of therapeutic devices.

(5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.

(6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:

(a) the person’s initials, date of birth and gender;

(b) each medical condition in relation to which the medicine was supplied;

(d) each active ingredient of the medicine;

(e) the dosage form of the medicine;

(f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;

(g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;

(h) the practitioner’s name, AHPRA number and contact details;

(i) the health profession in which the practitioner is registered or licensed to practise;

(j) the address of the practitioner’s principal place of practice.

12C Exemptions for health practitioners—biologicals

(1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.

(2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:

(a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and

(b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.

(3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.

(4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.

(5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:

(a) the person’s initials, date of birth and gender;

(b) each medical condition in relation to which the biological was supplied;

(d) a description of the biological, including the following:

(i) the product name of the biological;

(ii) each active ingredient of the biological;

(iii) the route of administration of the biological;

(e) the practitioner’s name, AHPRA number and contact details;

(f) the health profession in which the practitioner is registered or licensed to practise;

(g) the address of the practitioner’s principal place of practice.

15 Application of registration or listing number to goods

(1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:

(a) in the case of a therapeutic device included in the part of the Register for registered goods—by writing the number so that it is clearly visible to the user:

(i) on the label on the device; or

(ii) on the label on the outermost level of packaging in which the device is to be supplied to its user;

and, where more than one device is packaged for supply together, on the label on the outermost surface of the outermost package; and

(b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and

(c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:

(i) “AUST R” in the case of registered goods; and

(ii) unless subparagraph (iii) applies—“AUST L” in the case of listed goods; and

(iii) “AUST L(A)” in the case of goods listed under section 26AE of the Act;

the numbers and letters in each case being not less than 1 millimetre in height.

(2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.

15A Conditions of registration and listing of medicines

For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.

16 Listing of Therapeutic Goods

(1) For the purposes of paragraph 26(1)(g) of the Act, the therapeutic devices specified in Schedule 6 are prescribed.

16AA Information or documents that Secretary may require

Information or documents relating to registered goods

(1) For paragraph 31(1)(k) of the Act, the following matters are prescribed:

(a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;

(b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.

Information or documents relating to listed goods

(2) For paragraph 31(2)(h) of the Act, the following matters are prescribed:

(a) the efficacy of the goods for the purposes for which the goods are to be used;

(b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;

(c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.

Information or documents relating to biologicals

(3) For paragraph 32JA(1)(p) of the Act, the following matters are prescribed:

(a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;

(b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.

16AB Specified periods

For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:

(a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;

(b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;

(c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.

Part 3A—Applications for evaluation

Division 1—Preliminary

16A Interpretation—working day

(1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.

(2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:

(a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:

(i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or

(ii) if subsection 31(1B) or (1C) of the Act applies:

(A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or

(B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.

(b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and

Division 1A—Goods mentioned in Part 1 of Schedule 10

16C Applications for registration—notification of effectiveness and period for completing evaluations—general

Application of this regulation

(1) This regulation applies if the Secretary receives an application:

(a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and

(b) to which regulation 16G does not apply.

Giving notification whether application has passed preliminary assessment

(2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.

Period for completing evaluation in relation to application

(3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:

(a) if the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or

(b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or

beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.

16D Applications for variations—notification of effectiveness and period for deciding applications—general

Application of this regulation

(1) This regulation applies if the Secretary receives an application:

(a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and

(b) to which regulation 16F does not apply.

Giving notification of effectiveness of application

(2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.

Period for completing evaluation in relation to application

(3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:

(a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or

(b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or

beginning on the day the Secretary sends the notification that states that the application is effective.

16DA Conditions for periods for regulations 16C and 16D

Conditions for 175 day period

(1) For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (b), the conditions are the following:

(a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;

(c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;

(d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;

(e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;

(f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;

(g) if the evaluation medicine is a generic product in comparison to a registered medicine:

(i) the indications of the evaluation medicine are identical to the indications of the registered medicine; and

(ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;

(h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;

(i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;

(j) the assessment mentioned in paragraph (i):

(i) is complete and unredacted; and

(ii) is in English; and

(iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and

(iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and

(v) includes the competent regulatory authority’s final decision; and

(vi) includes any certifications or authentications of reports relating to the approval; and

(vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).

Conditions for 120 day period

(2) For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (b), the conditions are the following:

(aa) the approval for the acceptable foreign approved medicine:

(i) is in force; and

(ii) was given not more than 12 months before the date of the application in relation to the evaluation;

(a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;

(b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;

(c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;

(d) no additional information is required to complete the evaluation, other than:

(i) the label and product information for the evaluation medicine; and

(ii) the risk management plan (if any) for the evaluation medicine.

Determining foreign countries or foreign jurisdictions

(3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.

16E Applications for variations—effect of failure to decide applications within specified period

The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16F Applications for variations—shorter period for deciding applications

(1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:

(a) the specifications for the active ingredient, finished product or excipients; or

(b) the method of manufacture of the active ingredient; or

(d) the site of manufacture of the active ingredient or the finished product; or

(e) the shelf life; or

(f) the storage conditions; or

(g) the labelling; or

(h) any other particular that is not a particular mentioned in subsection 16(1) of the Act.

(2) This regulation does not apply to an application that:

(a) in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data; or

(b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.

(3) In the case of an application to which this regulation applies, the Secretary must:

(a) decide the application and notify the applicant of the decision; or

(b) raise an objection concerning the application;

within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.

(4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.

(5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.

16G Applications for registration—shorter period for completing evaluations

(1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:

(a) the application is received by the Secretary on or after 1 July 1992; and

(b) the application requires an evaluation under section 25 of the Act; and

(c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.

(2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.

(3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.

Division 2—Applications for evaluation of substances

16GA Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act

(1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:

(a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;

(b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.

(2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.

Exemption from fee

(3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.

Division 3—Class 2, Class 3 and Class 4 biologicals

16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made

(1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.

(2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.

(3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).

16GD Notification of effective request and period within which certain applications must be decided

(1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.

(2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.

(3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.

16GE Failure to decide an application within specified time

The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GF Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act

(1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:

(a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;

(b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.

(2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.

Division 4—Complementary medicines and certain other listed medicines

16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made

(1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.

(2) If the Secretary receives a request of a kind mentioned in column 1 of an item in the following table:

(a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and

(b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.

Notification of effective requests and period within which decisions must be made
Item	Column 1 Kind of request	Column 2 Notification of effective requests	Column 3 Decision on request
1	RCMC2 (section 9D) request	Within 40 working days after the Secretary receives the request	Within 64 working days after the Secretary notifies the applicant that the request has been accepted
2	RCMC3 (section 9D) request	Within 40 working days after the Secretary receives the application	Within 120 working days after the Secretary notifies the applicant that the request has been accepted
3	RCMC4 (section 9D) request	Within 40 working days after the Secretary receives the application	Within 170 working days after the Secretary notifies the applicant that the request has been accepted

(3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed

(1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:

(a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and

(b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.

Notification of preliminary assessment of application and period within which evaluations must be completed
Item	Column 1 Kind of application	Column 2 Notification of preliminary assessment	Column 3 Completion of evaluation
1	L(A)1 application	Within 40 working days after the Secretary receives the application	Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
2	L(A)2 application	Within 40 working days after the Secretary receives the application	Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
3	L(A)3 application	Within 40 working days after the Secretary receives the application	Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
4	RCM1 application	Within 40 working days after the Secretary receives the application	Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
5	RCM2 application	Within 40 working days after the Secretary receives the application	Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
6	RCM3 application	Within 40 working days after the Secretary receives the application	Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
7	RCM4 application	Within 40 working days after the Secretary receives the application	Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
8	RCM5 application	Within 40 working days after the Secretary receives the application	Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
9	RCMC1 (section 23) application	Within 40 working days after the Secretary receives the application	Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
10	RCMC2 (section 23) application	Within 40 working days after the Secretary receives the application	Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
11	RCMC3 (section 23) application	Within 40 working days after the Secretary receives the application	Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment
12	RCMC4 (section 23) application	Within 40 working days after the Secretary receives the application	Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment

(2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GI Variation of section 26BB determinations—notification of acceptance or rejection of applications and period within which recommendation decisions must be made

(1) If the Secretary receives an application of a kind mentioned in column 1 of an item in the following table:

(a) the Secretary must notify the applicant in writing as to whether the application has been accepted or rejected within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and

(b) if the application is accepted—a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.

Notification of acceptance or rejection of application and period within which decisions on recommendations must be made
Item	Column 1 Kind of application	Column 2 Notification of acceptance or rejection	Column 3 Decision on recommendation
1	IN1 application	Within 40 working days after the Secretary receives the application	Within 70 working days after the Secretary notifies the applicant that the application has been accepted
2	IN2 application	Within 40 working days after the Secretary receives the application	Within 120 working days after the Secretary notifies the applicant that the application has been accepted
3	IN3 application	Within 40 working days after the Secretary receives the application	Within 150 working days after the Secretary notifies the applicant that the application has been accepted
4	IN4 application	Within 40 working days after the Secretary receives the application	Within 180 working days after the Secretary notifies the applicant that the application has been accepted

(2) A failure to decide an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.

16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications

The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:

(a) an IN1 application;

(b) an IN2 application;

(d) an L(A)2 application;

(e) an RCM2 application;

(f) an RCM3 application;

(g) an RCM4 application.

Part 3B—Designated orphan drugs

16H Application to designate medicine as orphan drug

(1) The sponsor of a medicine may apply to the Secretary to designate, in writing, the medicine as an orphan drug.

(2) An application under subregulation (1) must be in a form approved, in writing, by the Secretary.

16J Designation of medicine as orphan drug

(1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:

(a) consider the application; and

(b) decide either:

(i) to designate the medicine as an orphan drug; or

(ii) to refuse to designate the medicine as an orphan drug.

(2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:

(a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or

(b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.

General criteria

(3) The following criteria are specified in relation to a medicine that is not a new dosage form medicine:

(a) the application is for only one indication of the medicine;

(b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);

(c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;

(d) at least one of the following applies:

(i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;

(ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;

(iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;

(e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:

(i) the Secretary;

(ii) the United States Food and Drug Administration;

(iii) the European Medicines Agency;

(iv) Health Canada;

(v) the Medicines and Healthcare products Regulatory Agency of the United Kingdom;

(f) either:

(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.

New dosage form medicines

(4) The following criteria are specified in relation to a new dosage form medicine:

(a) the application is for only one indication of the medicine;

(b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;

(c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;

(d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:

(i) the Secretary;

(ii) the United States Food and Drug Administration;

(iii) the European Medicines Agency;

(iv) Health Canada;

(v) the Medicines and Healthcare products Regulatory Agency of the United Kingdom;

(e) either:

(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.

Publication of decision

(5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:

(a) the name of the sponsor of the medicine;

(b) the indication referred to in paragraph (3)(a) or (4)(a);

(d) that the medicine is a designated orphan drug.

Notification of decision

(6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.

(7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.

16K Period during which designation is in force

(1) A designation under regulation 16J of a medicine as an orphan drug:

(a) comes into force when it is made; and

(b) remains in force for a period of 6 months.

(2) Subregulation (1) has effect subject to regulations 16L and 16M.

16L Extension of designation

(1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.

(2) An application under subregulation (1) to extend a designation must:

(a) be in a form approved, in writing, by the Secretary; and

(b) be made at least 28 days before the designation would cease to be in force.

(3) On receiving an application under subregulation (1) to extend a designation, the Secretary must decide either:

(a) to extend the designation; or

(b) to refuse to extend the designation.

(4) The Secretary may extend the designation if:

(a) the Secretary has not previously extended the designation; and

(b) the Secretary is satisfied that:

(i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or

(ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and

(c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.

Notification of decision

(5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.

(6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.

16M Revocation of designation

(1) The Secretary may, by written notice given to the sponsor of a designated orphan drug, revoke the designation:

(a) on application by the sponsor; or

(b) if the Secretary is satisfied that:

(i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug; or

(ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug.

(2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.

Part 3C—Therapeutic goods (priority applicant) determinations

16P Application of Part

For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.

16Q Application for therapeutic goods (priority applicant) determination

(1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.

(2) An application under subregulation (1) must:

(a) be in writing; and

(b) be in a form approved, in writing, by the Secretary; and

(c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.

(3) An application under subregulation (1) is taken not to have been made unless:

(a) the application meets the requirements in subregulation (2); and

(b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.

Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.

16R Making of therapeutic goods (priority applicant) determination

(1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:

(a) consider the application; and

(b) decide either:

(i) to make the determination; or

(ii) to refuse to make the determination.

Criteria

(2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:

(a) the medicine is:

(i) a new prescription medicine; or

(ii) a new indications medicine;

(b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;

(ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;

(d) there is substantial evidence demonstrating that the medicine provides a major therapeutic advance.

Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.

Information to be specified in determination

(3) The determination must specify:

(a) the person who, as a result of section 25AAA of the Act, is the priority applicant; and

(b) each active ingredient of the medicine to which the determination relates; and

Notification of decision

(4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.

(5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.

16S Period during which therapeutic goods (priority applicant) determination is in force

(1) A therapeutic goods (priority applicant) determination in relation to a medicine:

(a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and

(b) subject to subregulation (2) and regulation 16T, remains in force for 6 months.

(2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:

(a) the priority applicant withdraws the application; or

(b) the application lapses in accordance with subsection 24(2) of the Act; or

(c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or

(d) the application is finally determined.

Note: See subsection 23B(3) of the Act for when an application passes preliminary assessment.

16T Revocation of therapeutic goods (priority applicant) determination

(1) The Secretary may revoke a therapeutic goods (priority applicant) determination in relation to a medicine if:

(a) either:

(i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or

(ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and

(b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.

Note: See subsection 23B(3) of the Act for when an application passes preliminary assessment.

(2) The revocation must be by written notice given by the Secretary to the priority applicant.

Part 4—Licensing of manufacturers

17 Exempt goods for the purposes of subsection 34(1) of the Act

(1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.

(2) If:

(a) therapeutic goods that are exempt from the operation of Part 3‑3 of the Act cease to be exempt; and

(b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;

the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.

18 Exempt Persons

For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.

19 Requirements for licence holders

For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:

(a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and

(b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:

(i) the production of the goods; and

(ii) the quality control measures that are to be employed in the manufacture of the goods.

20 Conditions of licences

For the purposes of section 40 of the Act, the following are conditions to which each licence is subject:

(a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;

(b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:

(i) keep records showing:

(A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and

(B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and

(D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and

(ii) where the goods to which the licence relates are produced in identifiable batches:

(A) assign a batch number to each batch of the goods; and

(B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and

(iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and

(iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control;

(c) the licence holder must comply with the provisions of Part 5 in relation to the taking of samples by authorised officers.

21 Persons having control of production etc to be named

If:

(a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and

(b) the licence is granted; and

then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.

22 Transfer of licences

(1) If a person who was the holder of a licence dies, the legal personal representative of the dead person:

(a) is taken to be the holder of the licence; and

(b) must notify the Secretary, in writing, of the death not later than 3 months after it occurred.

(2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:

(a) is taken to be the holder of the licence; and

(b) must notify the Secretary, in writing, of the bankruptcy not later than 3 months after the person became bankrupt.

(3) If a body corporate that is the holder of a licence is being wound up, the liquidator of the body corporate:

(a) is taken to be the holder of the licence; and

(b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.

(4) If:

(a) a person agrees to dispose of a business relating to the manufacture, distribution or sale of therapeutic goods; and

(b) it is agreed that the disposal of that business is to include a transfer of a licence held by that person;

then:

(d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.

(4A) If a person who is the holder of a licence:

(a) changes his, her or its name; or

(b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;

the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.

(4B) The licence has effect as if it had been granted to the holder in the holder’s new name.

(5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.

(6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.

(7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.

(8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.

Part 5—Examination, testing and analysis of goods

23 Interpretation

(1) In this Part, unless the contrary intention appears:

relevant test:

(a) in relation to the analysis of therapeutic goods (other than medical devices), means a test that, under subregulation 28(1), is a relevant test for the purpose of determining whether goods of a class in which the first‑mentioned goods are included are goods that conform with a standard applicable to the goods; and

(b) in relation to the analysis of a medical device, means a test that, under subregulation 28(2), is a relevant test for the purpose of determining whether a medical device of that kind complies with the applicable provisions of the essential principles.

responsible analyst, in relation to the analysis of a sample of therapeutic goods, means an official analyst who is nominated as a responsible analyst for the sample under paragraph 25(3)(c).

samples officer means an officer of the Department performing duties under the direction of an official analyst.

(2) For this Part, a sample of therapeutic goods is appropriately fastened and sealed if the sample is fastened and sealed:

(a) in a vessel or package that is marked with the name and address of:

(i) the person from whom the sample was taken; or

(ii) for a sample delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act—the sponsor of the goods; and

(b) so as to prevent the opening of the vessel or package, and the removal of the name and address, without breaking the seal.

24 Authorised officer—powers and duties

(1) An authorised officer may, during normal business hours:

(a) for the purpose of exercising the powers and performing the duties of an authorised officer under this regulation, enter the premises of a licence holder, manufacturer in respect of whom a conformity assessment certificate has been issued, or wholesaler on which therapeutic goods are kept for supply; and

(b) inspect the place at which those goods are kept; and

(d) ask the owner of therapeutic goods, or the person apparently in charge of those goods, for information relevant to the manufacture and testing of those goods.

(2) If the entry of goods in the Register is subject to the condition that the sponsor of the goods comply with this regulation, the powers of an authorised officer referred to in subregulation (1) extend to the sponsor as if the sponsor were a licence holder or a manufacturer in respect of whom a conformity assessment certificate has been issued.

25 Official analysts

(1) The Secretary may, in writing, appoint a person who has appropriate qualifications and experience to be an official analyst for the purposes of these Regulations.

(2) The Secretary is to maintain a register of the names of official analysts and is to cause those names to be published in the Gazette or on the Department’s website from time to time.

(3) In addition to the other powers and functions of an official analyst, an official analyst may:

(a) ask an authorised officer to take samples of therapeutic goods; and

(b) determine the tests that are to be performed on a sample taken under paragraph (a) or delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act; and

(c) nominate an official analyst to be the responsible analyst for a sample taken under paragraph (a) or delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act.

26 Taking of samples for testing

(1) When an authorised officer takes a sample of therapeutic goods (other than a further sample taken under the circumstances described in subregulation 30(6)), the authorised officer:

(a) must notify the person from whom the sample was taken that the authorised officer is going to send the sample to a laboratory operated by the Department for analysis; and

(b) must give the person from whom the sample was taken a notice setting out details of the goods taken and, if the person from whom the sample was taken was not the sponsor of the goods, send a copy of that notice to the sponsor of the goods; and

(2) An authorised officer must ensure that any sample of goods taken (including further samples taken under the circumstances described in subregulation 30(6)) is:

(a) appropriately packaged, fastened and sealed; and

(b) stored and transported in accordance with the instructions (if any) specified on the label of the goods.

26A Receiving samples for testing

(1) When a sample of therapeutic goods is delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act, the Secretary must as soon as practicable:

(a) determine whether the sample is appropriately packaged, fastened and sealed; and

(b) do either of the following:

(i) if the sample is appropriately packaged, fastened and sealed—send the sample, in the form in which it was received, to the relevant laboratory operated by the Department for analysis;

(ii) if the sample is not appropriately packaged, fastened and sealed—return the sample to the sponsor of the goods, with a statement explaining in what way the sample is not appropriately packaged, fastened or sealed.

(2) In complying with subregulation (1), the Secretary must ensure that the sample is stored and transported in accordance with the instructions (if any) specified on the label of the goods.

27 Examination and testing of sample

(1) A samples officer must, as soon as practicable after receiving a sample of goods at a laboratory operated by the Department:

(a) determine whether the sample is appropriately packaged, fastened and sealed; and

(b) if the sample is appropriately packaged, fastened and sealed—store the sample under the officer’s control and under secure conditions that are appropriate to the kind of goods.

(2) The responsible analyst must, as soon as practicable, collect the sample from the samples officer and arrange for:

(a) an analysis of the sample by relevant tests to the extent the analyst considers necessary to establish:

(i) the quantity and quality of the goods comprising the sample; and

(ii) any other matter relevant to determining whether:

(A) for goods other than medical devices—the goods from which the sample was taken conform with any standard applicable to the goods and any conditions relating to matters mentioned in paragraph 28(2)(d) of the Act; and

(B) for medical devices—the goods from which the sample was taken comply with the applicable provisions of the essential principles and any conditions relating to matters mentioned in paragraph 41FO(2)(d) of the Act; and

(b) an examination of the goods, the label (if any) relating to the goods and the packaging of the goods, to determine whether the goods comply with the labelling, packaging and other requirements (including requirements relating to advertising) applicable to the goods.

28 Relevant tests

(1) Each of the following is a relevant test for determining whether particular therapeutic goods (other than medical devices) are goods that conform with a standard applicable to the goods:

(a) a test specified by the Minister in an order under section 10 of the Act for those goods in relation to that standard; and

(b) a test specified in a monograph in the British Pharmacopoeia in relation to that standard if:

(i) those goods are for use in humans; and

(ii) the Minister has not specified a test in an order under section 10 of the Act for those goods in relation to that standard; and

(i) those goods are for veterinary use; and

(ii) the Minister has not specified a test in an order under section 10 of the Act for those goods in relation to that standard; and

(d) a test accepted for the purposes of registration of the goods under Part 3‑2 of the Act; and

(e) any other suitable test that the Secretary requires to be carried out in respect of those goods in relation to that standard.

(2) Each of the following is a relevant test for determining whether a particular kind of medical device complies with the applicable provisions of the essential principles:

(a) a test specified in a medical device standard or conformity assessment standard for the kind of device;

(b) a test accepted for the purpose of issuing a conformity assessment certificate in respect of the kind of device;

(c) a test required under paragraph 41FO(2)(d) of the Act as a condition of inclusion of the kind of device in the Register;

(d) any other suitable test that the Secretary requires to be carried out in respect of the kind of device for the purpose of demonstrating compliance with the applicable provisions of the essential principles.

29 Certificate of official analyst

(1) The responsible analyst must send to the sponsor of the goods a certificate signed by the analyst setting out the results of the examination and analysis.

(2) The responsible analyst must send a copy of the certificate, signed by the analyst, to:

(a) the Secretary; and

(b) if the sample was taken under subregulation 25(3)—the person from whom the sample was taken, if that person is not the sponsor of the goods.

(3) The certificate and copies of the certificate of the official analyst must be sent to the persons referred to in subregulations (1) and (2) within a reasonable time of the completion of the analysis.

(4) If the certificate referred to in subregulation (1) states:

(a) for relevant goods other than medical devices—that the goods do not conform with a specified standard or comply with a requirement that is applicable to the goods under regulation 27; or

(b) for medical devices—that the goods do not comply with the applicable provisions of the essential principles or a requirement that is applicable to the goods under regulation 27;

the certificate, and the copy of it referred to in subregulation (2), must be accompanied by a notice that complies with subregulation (4A).

(4A) For subregulation (4), the notice must:

(a) state that the person to whom the certificate or copy is sent may ask for the results of the analysis referred to in the certificate to be reviewed in accordance with regulation 30; and

(b) specify the time within which a request for a review of the results may be made; and

(c) state that the person may ask for an extension of that time if it is not reasonable to expect the person to comply with regulation 30 within the specified time.

(5) In proceedings under the Act or these Regulations, a certificate of an official analyst issued under subregulation (1), or a copy of that certificate, is, in the absence of evidence to the contrary, conclusive proof of the matters set out or stated in it.

(6) A document purporting to be:

(a) a certificate of an official analyst issued under subregulation (1); or

(b) a copy of that certificate;

and purporting to be signed by an official analyst is, in the absence of evidence to the contrary, to be taken to be the certificate or a copy of the certificate and to have been issued under subregulation (1) or (2), as the case requires.

30 Review of findings of official analyst

(1) A person:

(a) to whom a certificate, setting out the results of an examination and analysis of goods, is issued under subregulation 29(1); and

(b) who sends to the Secretary evidence in writing establishing that the goods do conform with the specified standard or comply with an applicable requirement, or, for medical devices, do comply with the applicable provisions of the essential principles or an applicable requirement;

may ask for the results of the analysis to be reviewed.

(2) A request for review of the results of the analysis is to be made not later than 21 days after the person receives the certificate, or the copy of the certificate, as the case may be.

(3) The Secretary must extend the period of 21 days if it is not reasonable to expect the person to provide the evidence within the period referred to in subregulation (2).

(4) A person is not to be regarded as having sent the Secretary evidence establishing that goods conform with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, unless that person has sent to the Secretary a certificate of an analyst who has appropriate qualifications and experience setting out:

(a) a statement that the analyst has analysed a part of the same sample, or a similar sample from the same batch (if any), of those goods; and

(b) the results of that analysis; and

(5) If the certificate referred to in subregulation (4) shows that an analysis of goods for the purpose of establishing that the goods conform with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, was carried out in accordance with the relevant tests in relation to the goods, subregulation (6) applies to those goods.

(6) Unless the results of the analysis of a sample of goods to which this subregulation applies, or other information available to the Secretary in relation to those goods, shows lack of homogeneity in the sample, the Secretary, at the request of the sponsor of the goods, must direct:

(a) if part of the sample remains unimpaired—the official analyst to send so much of the sample as remains unimpaired; or

(b) if no part of the sample remains unimpaired—that a further sample be taken by an authorised officer from the same batch as the original sample and that that further sample be sent;

to an analyst agreed upon by the person who requested the review and the official analyst, or, in the absence of agreement, to an analyst nominated by the Secretary.

(7) If a sample is forwarded to an analyst referred to in subregulation (6), the analyst is to:

(a) analyse the sample of the goods in accordance with any relevant tests;

(b) send to the Secretary a certificate, signed by the analyst, setting out the results of the analysis; and

(8) A certificate under regulation 29 setting out the results of the analysis of a sample of goods ceases to have effect when the Secretary receives the certificate in relation to those goods under subregulation (7).

(9) If the findings of the official analyst are upheld, the sponsor must pay any charges payable to the analyst referred to in subregulation (6) in respect of the analysis of the sample.

(10) In proceedings under the Act or these Regulations, a certificate of an analyst issued under subregulation (7) or a copy of that certificate is, in the absence of evidence to the contrary, conclusive proof of the matters stated in it.

(11) A document purporting to be:

(a) a certificate of an analyst issued under subregulation (7); or

(b) a copy of that certificate, and purporting to be signed by the analyst;

is, in the absence of evidence to the contrary, to be regarded as the certificate, or a copy of the certificate, and to have been issued under that subregulation.

31 Payment for samples

(1) If a sample of therapeutic goods is taken by an authorised officer, the Commonwealth is liable to pay the owner of the goods from which the sample was taken an amount equal to the value of any part of the sample removed by the authorised officer.

(1A) If a sample of therapeutic goods delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act is sent to a laboratory for analysis, the Commonwealth is liable to pay to the person in relation to whom the goods are entered on the Register an amount equal to the value of the sample.

(2) The amount the Commonwealth is liable to pay is to be worked out on the basis of the market value of the sample when the sample was taken by the authorised officer or delivered under paragraph 28(5)(h) or subsection 41FN(2) of the Act.

32 Offences relating to analysis etc

(1) A person must not:

(a) molest, obstruct or try to intimidate or influence an authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or

(b) on being asked by an authorised officer, fail:

(i) to show the authorised officer the place where any therapeutic goods are kept; or

(ii) to admit the authorised officer to a place where therapeutic goods are kept; or

(iii) to show the authorised officer, or let the authorised officer inspect, therapeutic goods kept by the person; or

(iv) to allow a sample of therapeutic goods to be taken in accordance with these Regulations; or

(v) to give an authorised officer information required by the authorised officer, being information relevant to the manufacture and testing of therapeutic goods that the person is able to provide; or

(vi) to assist the authorised officer in the execution of his or her powers or the performance of his or her duties under these Regulations; or

(c) on being asked by an official analyst, fail to give any information required by the official analyst, being information relevant to the testing of therapeutic goods, that that person is able to provide.

Penalty: 10 penalty units.

(1A) For the purposes of an offence under paragraph (1)(a), strict liability applies to the physical element that the duties mentioned in that paragraph are duties under these Regulations.

Note: For strict liability, see section 6.1 of the Criminal Code.

(1B) An offence under paragraph (1)(b) or (c) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(1C) It is a defence to a prosecution under paragraph (1)(b) or (c) if the person has a reasonable excuse.

Note: A defendant bears an evidential burden in relation to the matter mentioned in subregulation (1C) (see section 13.3 of the Criminal Code).

(2) It is a reasonable excuse for a person to fail to comply with a request for information under paragraph (1)(b) or (c) if compliance with that request would tend to incriminate that person.

33 Identity cards

(1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.

(2) Where the authorised officer enters premises in the course of his or her duties under this Part, the authorised officer must, if requested to do so by any person at those premises, produce his or her identity card for inspection by that person.

(3) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.

Penalty: 1 penalty unit.

(4) An offence under subregulation (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

Part 5A—Exceptional release

33A Prescribed circumstances under which biologicals may be imported, exported or supplied

For paragraphs 14(5A)(b), (9A)(b), (13A)(b), 14A(1A)(b), (2A)(b) and (3A)(b) of the Act, the circumstances are:

(a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and

(b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and

(d) no other treatment option is suitable for the patient; and

(e) the nonconforming biological is assessed as the most suitable treatment for the patient; and

(f) the nonconforming biological is to be used only for the treatment of one patient.

33B Conditions for supply of biologicals

(1) For subsection 15AB(1) of the Act, the conditions are that:

(a) all the circumstances mentioned in regulation 33A have occurred; and

(b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:

(i) the proposal to use the nonconforming biological;

(ii) that the patient or guardian has been told about the likely risks and benefits from the use of the biological;

(iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and

(c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and

(d) before the biological is used:

(i) the patient or the patient’s guardian must give written informed consent; or

(ii) the treating medical practitioner must give written statement of the reasons that consent cannot be given; and

(e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.

(2) Within 28 days after the release of the nonconforming biological, the sponsor must give to the Secretary:

(a) a notification of use of the nonconforming biological, on a form approved by the Secretary; and

(b) a copy of the documents mentioned in paragraphs (1)(b) to (d); and

(c) any other information requested by the Secretary, including any information requested after submission of the notification.

(3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.

33C Report on release of nonconforming biological

For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:

(a) within 6 months after the release—a report that includes the following information:

(i) date of release;

(ii) product identification details;

(iii) name and address of transplant centre or medical practitioner to whom the nonconforming biological was released;

(iv) initials, gender and date of birth of patient;

(v) any adverse events relating to the use of the nonconforming biological; and

(b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:

(i) the decision making process leading to the supply; and

(ii) any adverse events related to the supply.

Part 6—Committees

Division 1A—Advisory Committee on Medicines

35 Establishment

The Advisory Committee on Medicines is established.

35A Functions

(1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:

(a) the safety, quality and efficacy of medicines, including in relation to pharmacovigilance;

(b) the entry of a medicine in the Register;

(d) the continued retention of a medicine in, or the removal of a medicine from, the Register;

(e) risk assessment and risk management of medicines;

(f) any other matter (whether or not related to a medicine), including a matter related to standards.

(2) The Minister or Secretary may require the committee to give its advice to other persons or bodies.

35B Membership

(1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).

(1A) Subject to subregulation (1B):

(a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and

(b) each member of the committee must have expertise in at least one of those fields.

(1B) One member of the committee may have expertise in consumer health issues.

(2) For the purposes of subregulation (1A), the fields are as follows:

(a) general medical practice in Australia;

(b) specialist medical practice of a kind that is relevant to the committee’s functions;

(d) clinical pharmacology or pharmacokinetics;

(e) paediatrics;

(f) gerontology;

(g) internal medicine, including the following:

(i) haematology;

(ii) oncology;

(iii) infectious diseases;

(iv) cardiology;

(v) gastroenterology or hepatology;

(vi) renal disease;

(vii) endocrinology;

(viii) neurology;

(ix) immunology;

(x) rheumatology;

(xi) respiratory disease;

(h) intensive care;

(i) anaesthetics;

(j) psychiatry;

(k) toxicology;

(l) pharmaceutical chemistry;

(m) microbiology;

(n) community or clinical pharmacy;

(o) manufacture of medicines;

(p) dermatology;

(q) obstetrics or gynaecology;

(r) ophthalmology;

(s) radiology;

(t) medical genetics;

(u) developmental or reproductive toxicology;

(v) medicines in pregnancy;

(w) medical ethics.

Division 1D—Advisory Committee on Medical Devices

38 Establishment

The Advisory Committee on Medical Devices is established.

38A Functions

(aa) the safety, performance and manufacturing of a medical device;

(a) the inclusion of a medical device or other therapeutic goods in the Register;

(b) the variation of an entry for a medical device or other therapeutic goods in the Register;

(c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;

(d) risk assessment and risk management of medical devices;

(e) any other matter (whether or not related to a medical device or other therapeutic goods).

(2) The Minister or Secretary may require the committee to give its advice to other persons or bodies.

38B Membership

(1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).

(2) Subject to subregulation (3):

(a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and

(b) each member of the committee must have either or both of the following:

(i) medical or surgical expertise in one of the fields mentioned in subregulation (4);

(ii) expertise in at least one of the fields mentioned in subregulation (5).

(3) One member of the committee may have expertise in consumer health issues.

(4) For the purposes of paragraph (2)(a) and subparagraph (2)(b)(i), the fields are as follows:

(a) anaesthetics;

(b) cardiology;

(d) dentistry or oro‑maxillofacial surgery;

(e) ear, nose and throat;

(f) gastroenterology;

(g) neurology;

(h) obstetrics or gynaecology;

(i) ophthalmology;

(j) orthopaedics;

(k) pathology;

(l) plastic and reconstructive surgery;

(m) renal;

(n) respiratory medicine;

(o) vascular medicine;

(p) any other medical or surgical field of expertise that is relevant to the committee’s functions.

(5) For the purposes of paragraph (2)(a) and subparagraph (2)(b)(ii), the fields are as follows:

(a) biomedical engineering or biomaterials;

(b) epidemiology or biostatistics;

(d) human factors analysis;

(e) interventional cardiology;

(f) interventional radiology;

(g) manufacture of medical devices;

(h) medical device software engineering;

(i) nursing;

(j) any other clinical or technical field of expertise that is relevant to the committee’s functions.

Division 1E—Advisory Committee on Complementary Medicines

39 Establishment

The Advisory Committee on Complementary Medicines is established.

39A Functions

(a) the safety, efficacy and manufacturing quality of a complementary medicine;

(b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;

(c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;

(d) the registration or listing of a complementary medicine;

(e) the variation of an entry for a complementary medicine in the Register;

(f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;

(g) any other matter (whether or not related to a complementary medicine), including a matter related to standards.

(2) The Minister or Secretary may require the committee to give its advice to other persons or bodies.

39B Membership

(1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).

(1A) Subject to subregulation (1B):

(a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and

(b) each member of the committee must have expertise in at least one of those fields.

(1B) One member of the committee may have expertise in consumer health issues.

(2) For the purposes of subregulation (1A), the fields are as follows:

(a) complementary medical practice;

(b) manufacture of medicines;

(d) general medical practice in Australia;

(e) herbal medicine;

(f) naturopathy;

(g) nutrition and nutritional medicine;

(h) pharmacology;

(i) pharmacognosy;

(j) toxicology;

(k) epidemiology.

Division 1EA—Advisory Committee on Biologicals

39C Establishment

The Advisory Committee on Biologicals is established.

39D Functions

(aa) the safety and efficacy of a biological;

(a) the inclusion of a biological in the Register under Part 3‑2A of the Act;

(b) the variation of an entry for a biological included in the Register under Part 3‑2A of the Act;

(d) any other matter (whether or not related to a biological), including a matter related to standards.

(2) The Minister or Secretary may require the committee to give its advice to other persons or bodies.

39E Membership

(1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).

(1A) Subject to subregulation (1B):

(a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and

(b) each member of the committee must have expertise in at least one of those fields.

(1B) One member of the committee may have expertise in consumer health issues.

(2) For the purposes of subregulation (1A), the fields are as follows:

(a) infectious diseases;

(b) tissue products;

(d) cellular therapies, including tissue engineering;

(g) clinical expertise;

(h) epidemiology or biostatistics;

(i) toxicology.

Division 1EB—Advisory Committee on Vaccines

39F Establishment

The Advisory Committee on Vaccines is established.

39G Functions

(a) the safety, quality and efficacy of vaccines, including in relation to pharmacovigilance;

(b) the registration of a vaccine;

(d) the continued retention of a vaccine in, or the removal of a vaccine from, the Register;

(e) risk assessment and risk management of vaccines;

(f) any other matter (whether or not related to a vaccine), including a matter related to standards.

(2) The Minister or Secretary may require the committee to give its advice to other persons or bodies.

39H Membership

(1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).

(1A) Subject to subregulations (1B) and (2):

(a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and

(b) each member of the committee must have expertise in at least one of those fields.

(1B) One member of the committee may have expertise in consumer health issues.

(2) The Minister may appoint one member from each of the following:

(a) the Australian Technical Advisory Group on Immunisation;

(b) the National Immunisation Committee;

(d) the National Centre for Immunisation Research and Surveillance.

(3) For the purposes of subregulation (1A), the fields are as follows:

(a) immunology;

(b) virology;

(d) infectious diseases in adults or children;

(e) public health;

(f) epidemiology or biostatistics;

(g) vaccine program implementation;

(h) the provision of immunisation treatment by an individual;

(i) paediatrics;

(j) nursing.

Division 1F—General

40 Application of this Division

This Division applies to committees mentioned in Divisions 1A, 1D, 1E, 1EA and 1EB.

41 Appointment of members

(1) A member is appointed to a committee for the term stated in the member’s instrument of appointment.

(2) A term of appointment must not be longer than 3 years.

(3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.

(4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.

41A Appointment of the chair

The Minister must appoint, in writing, a member of a committee to be its chair.

41B Resignation or vacancy

(1) A member or chair may resign by giving written notice to the Minister.

(2) If a chair ceases to be a member of a committee, the position is taken to be vacant.

41C Termination of appointment

(1) The Minister may terminate a member’s appointment on any of the following grounds:

(a) physical or mental incapacity;

(b) misbehaviour;

(d) bankruptcy;

(e) failing to comply with the disclosure of interest requirements mentioned in regulation 42.

(2) The Minister must terminate a member’s appointment if:

(a) the member is convicted of an offence punishable by imprisonment for at least 1 year; or

(b) if the member is absent without leave of absence from 3 consecutive meetings of the committee.

41D Leave of absence

(1) The Minister may grant leave of absence to the chair.

(2) The chair may grant leave of absence to another committee member.

41E Acting members

(1) The Minister may appoint a person to act as a member of a committee.

(2) A person may act as a member of a committee:

(a) during a vacancy in the office, whether or not an appointment has previously been made to the office; or

(b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.

(3) A person appointed to act in an office must, to the extent reasonably practicable:

(a) if a particular qualification is required for a substantive member—hold that qualification; or

(b) if different qualifications are required for all members of the committee—hold 1 of those qualifications.

(4) A person appointed to act during a vacancy must not continue to act for more than 12 months.

41F Committee procedures

In performing its functions, a committee:

(a) must act in accordance with this Division; and

(b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and

(d) may obtain information about an issue in any way it considers appropriate (subject to subregulation 42(9)); and

(e) may receive information or submissions orally or in writing; and

(f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).

41G Meetings

(1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.

(2) The procedure of a meeting must be determined by the committee in accordance with this Division.

41H Presiding member

(1) The chair must preside at a committee meeting or nominate a member of the committee to preside at the meeting.

(2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.

(3) A member chosen to preside under subregulation (2) may exercise the powers and functions of the chair.

41I Quorum

A quorum exists at a committee meeting when:

(a) at least half of the members are present; or

(b) at least half of the members who have been directed to hold the meeting under subregulation 41G(1) are present.

41J Voting

(1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.

(2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.

42 Miscellaneous

Sitting fees and travel entitlements

(1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.

When committee may establish subcommittees

(2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.

(3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.

Disclosure of interests

(4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.

(5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.

(6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.

(7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.

Seeking further advice

(8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.

(9) In performing its functions, a committee may seek advice from other persons.

Validity of acts of members

(10) Anything done by a person purporting to be or act as a member (including a chair) is not invalid because:

(a) the person had not yet been appointed; or

(b) there is a defect or irregularity in connection with the person’s appointment; or

Records and reports

(11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.

Publication of recommendations of committees

(12) The Secretary must publish the recommendations of each committee.

Division 3A—Advisory Committee on Medicines Scheduling

Subdivision 3A.1—Preliminary

42ZCA Definitions for Division 3A

In this Division:

appointed member means a member of the Committee appointed by the Minister under subregulation 42ZCD(1).

Committee means the Advisory Committee on Medicines Scheduling.

Note: The Committee is established by section 52B of the Act.

Committee member means an appointed member or a nominated member.

nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.

Subdivision 3A.2—Constitution of Committee

42ZCB Membership of Committee

For subsection 52B(2) of the Act, the Committee is to be constituted in accordance with this Subdivision.

42ZCC Committee members

(1) The Committee comprises each nominated member and no more than 8 appointed members.

(2) A Committee member must have expertise in at least one of the following fields:

(a) the regulation of scheduled medicines in Australia;

(b) toxicology or pharmacology;

(d) pharmacy practice;

(e) medical practice;

(f) consumer health issues relating to the regulation of therapeutic goods;

(g) industry issues relating to the regulation of therapeutic goods.

(3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).

42ZCD Appointed members

(1) An appointed member must be appointed in writing by the Minister.

(2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.

(3) An appointed member must not be appointed for more than 3 consecutive terms.

42ZCE Nominated members

(1) This regulation is made for subsection 52B(3) of the Act.

(2) A nomination must be in writing.

(3) The nomination must specify the term of the nominee’s membership of the Committee.

(4) The nominee becomes a member of the Committee when the nomination is given to the Minister.

(5) A nominated member stops being a member if:

(a) the body that nominated the member gives the Minister written notice that the member’s nomination is withdrawn; or

(b) the member, by written notice given to the Minister under subregulation 42ZCG(1), resigns from the Committee.

(6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:

(a) during a vacancy in the existing member’s office; or

(b) during any period, or all periods, when the existing member is:

(i) absent from duty or from Australia; or

(ii) for any other reason unable to perform the functions of a nominated member.

(7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:

(a) when the circumstance giving rise to the temporary replacement commences; and

(b) until that circumstance ends.

42ZCF Appointment of the Chair and acting Chair

(1) The Minister must, in writing, appoint a Committee member to be the Chair of the Committee.

(2) The Chair is appointed for the term stated in the appointment but may be reappointed for further terms.

(3) The Minister may, in writing, appoint a Committee member to act as the Chair:

(a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or

(b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.

Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.

42ZCG Resignation or vacancy

(1) A Committee member or Chair may resign by giving written notice to the Minister.

(2) If the Chair ceases to be a Committee member, the position is taken to be vacant.

42ZCH Termination of appointment

(1) The Minister may terminate an appointed member’s appointment on any of the following grounds:

(a) physical or mental incapacity;

(b) misbehaviour;

(d) bankruptcy;

(e) failing to comply with the disclosure of interest requirements mentioned in regulation 42ZCP.

(2) The Minister must terminate an appointed member’s appointment if:

(a) the member is convicted of an offence punishable by imprisonment for at least 1 year; or

(b) if the member is absent without leave of absence from 3 consecutive meetings of the Committee.

42ZCI Leave of absence

(1) The Minister may grant leave of absence to the Chair.

(2) The Chair may grant leave of absence to a Committee member.

42ZCJ Acting members

(1) The Minister may, in writing, appoint a person to act as an appointed member:

(a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or

(b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.

(2) A person appointed to act as an appointed member must have the expertise required for a substantive member.

Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.

Subdivision 3A.3—Committee meetings

42ZCK Committee meetings

For subsection 52B(2) of the Act, the Committee is to hold meetings in accordance with this Subdivision.

42ZCL Meeting procedure

(1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.

(2) The procedure of a meeting must be determined by the Committee in accordance with this Subdivision.

(3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.

(4) At a meeting, the Committee:

(a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and

(b) is not bound by the rules of evidence; and

(d) may receive information in any way it considers appropriate; and

(e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).

(5) For this regulation:

out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.

42ZCM Presiding member

(1) The Chair must preside at a Committee meeting at which he or she is present.

(2) If the Chair is unable to preside at a meeting, he or she must:

(a) select a member of the Committee to preside at the meeting; and

(b) advise the other Committee members of the selection.

(3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.

(4) A member presiding under subregulation (2) or (3) may exercise the powers and functions of the Chair.

42ZCN Quorum

A quorum exists at a Committee meeting when at least half of the Committee members are present.

42ZCO Voting

(1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.

Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.

(2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.

42ZCP Miscellaneous

Sitting fees and travel entitlements

(1) An appointed member is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.

When Committee may establish subcommittees

(2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.

(3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.

Disclosure of interests

(4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.

(5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.

(6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.

(7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.

Seeking and providing further advice

(8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.

(9) In performing its functions, the Committee may seek advice from other persons.

Validity of acts of members

(10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:

(a) the person had not yet been appointed; or

(b) there is a defect or irregularity in connection with the person’s appointment; or

Records and reports

(11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.

Publication

(12) The Committee must publish details of any recommendations it makes.

Division 3B—Advisory Committee on Chemicals Scheduling

Subdivision 3B.1—Preliminary

42ZCQ Definitions for Division 3B

In this Division:

appointed member means a member of the Committee appointed by the Minister under subregulation 42ZCT(1).

Committee means the Advisory Committee on Chemicals Scheduling.

Note: The Committee is established by section 52C of the Act.

Committee member means an appointed member or a nominated member.

nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.

Subdivision 3B.2—Constitution of Committee

42ZCR Membership of Committee

For subsection 52C(2) of the Act, the Committee is to be constituted in accordance with this Subdivision.

42ZCS Committee members

(1) The Committee comprises each nominated member and no more than 8 appointed members.

(2) A Committee member must have expertise in at least one of the following fields:

(a) the regulation of scheduled chemicals in Australia;

(b) veterinary medicine or veterinary pathology;

(d) industrial or domestic chemicals;

(e) agricultural or veterinary chemicals;

(f) clinical aspects of human poisoning;

(g) occupational health, particularly as a medical practitioner;

(h) consumer health issues relating to the regulation of chemicals;

(i) industry issues relating to the regulation of chemicals.

(3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).

42ZCT Appointed members

(1) An appointed member must be appointed in writing by the Minister.

(2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.

(3) An appointed member must not be appointed for more than 3 consecutive terms.

42ZCU Nominated members

(1) This regulation is made for subsection 52C(3) of the Act.

(2) A nomination must be in writing.

(3) The nomination must specify the term of the nominee’s membership of the Committee.

(4) The nominee becomes a member of the Committee when the nomination is given to the Minister.

(5) A nominated member stops being a member if:

(a) the body that nominated the member gives the Minister written notice that the member’s nomination is withdrawn; or

(b) the member, by written notice given to the Minister under subregulation 42ZCW(1), resigns from the Committee.

(a) during a vacancy in the existing member’s office; or

(b) during any period, or all periods, when the existing member is:

(i) absent from duty or from Australia; or

(ii) for any other reason unable to perform the functions of a nominated member.

(7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:

(a) when the circumstance giving rise to the temporary replacement commences; and

(b) until that circumstance ends.

42ZCV Appointment of the Chair and acting Chair

(1) The Minister must, in writing, appoint a Committee member to be the Chair of the Committee.

(2) The Chair is appointed for the term stated in the appointment but may be reappointed for further terms.

(3) The Minister may, in writing, appoint a Committee member to act as the Chair:

(a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or

(b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.

Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.

42ZCW Resignation or vacancy

(1) A Committee member or Chair may resign by giving written notice to the Minister.

(2) If the Chair ceases to be a Committee member, the position is taken to be vacant.

42ZCX Termination of appointment

(1) The Minister may terminate an appointed member’s appointment on any of the following grounds:

(a) physical or mental incapacity;

(b) misbehaviour;

(d) bankruptcy;

(e) failing to comply with the disclosure of interest requirements mentioned in regulation 42ZCZF.

(2) The Minister must terminate an appointed member’s appointment if:

(a) the member is convicted of an offence punishable by imprisonment for at least 1 year; or

(b) if the member is absent without leave of absence from 3 consecutive meetings of the Committee.

42ZCY Leave of absence

(1) The Minister may grant leave of absence to the Chair.

(2) The Chair may grant leave of absence to a Committee member.

42ZCZ Acting members

(1) The Minister may, in writing, appoint a person to act as an appointed member:

(a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or

(b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.

(2) A person appointed to act as an appointed member must have the expertise required for a substantive member.

Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.

Subdivision 3B.3—Committee meetings

42ZCZA Committee meetings

For subsection 52C(2) of the Act, the Committee is to hold meetings in accordance with this Subdivision.

42ZCZB Meeting procedure—general

(2) The procedure of a meeting must be determined by the Committee in accordance with this Subdivision.

(4) At a meeting, the Committee:

(a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and

(b) is not bound by the rules of evidence; and

(d) may receive information in any way it considers appropriate; and

(5) For this regulation:

42ZCZC Presiding member

(1) The Chair must preside at a Committee meeting at which he or she is present.

(2) If the Chair is unable to preside at a meeting, he or she must:

(a) select a member of the Committee to preside at the meeting; and

(b) advise the other Committee members of the selection.

(3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.

(4) A member presiding under subregulation (2) or (3) may exercise the powers and functions of the Chair.

42ZCZD Quorum

A quorum exists at a Committee meeting when at least half of the Committee members are present.

42ZCZE Voting

(1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.

Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.

(2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.

42ZCZF Miscellaneous

Sitting fees and travel entitlements

(1) An appointed member is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.

When Committee may establish subcommittees

(2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.

(3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.

Disclosure of interests

Seeking and providing further advice

(8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.

(9) In performing its functions, the Committee may seek advice from other persons.

Validity of acts of members

(10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:

(a) the person had not yet been appointed; or

(b) there is a defect or irregularity in connection with the person’s appointment; or

Records and reports

(11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.

Publication

(12) The Committee must publish details of any recommendations it makes.

Division 3C—Joint meetings

42ZCZG Joint meetings

For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.

42ZCZH Procedure for joint meetings

(1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.

(2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.

(3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.

(4) There is a quorum at a joint meeting if there is a quorum for each Committee.

(5) At a joint meeting:

(a) decisions are to be made by a majority of the votes cast by the members present and voting; and

(b) each member has one vote in respect of each Committee of which he or she is a member.

(6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.

Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.

(7) Each Committee must keep a record of the proceedings of the joint meeting.

Division 3D—Procedure for amending the current Poisons Standard

Subdivision 3D.1—Preliminary

42ZCZI Definitions for Division 3D

In this Division:

business day means a day that is not a Saturday, Sunday or public holiday in the Australian Capital Territory.

Committee member means a member of:

(a) the Advisory Committee on Medicines Scheduling; or

(b) the Advisory Committee on Chemicals Scheduling.

expert advisory committee means:

(a) the Advisory Committee on Medicines Scheduling; or

(b) the Advisory Committee on Chemicals Scheduling; or

first closing date has the meaning given by paragraph 42ZCZK(1)(d).

interim decision means:

(a) in Subdivision 3D.2—a decision of the Secretary under regulation 42ZCZN; and

(b) in Subdivision 3D.3—a decision of the Secretary under paragraph 42ZCZV(a).

proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.

public submission means a submission under this Division by a person who is not a Committee member.

relevant submission has the meaning given by paragraph 42ZCZQ(1)(a).

second closing date has the meaning given by paragraph 42ZCZP(1)(c).

Note: For current Poisons Standard see s 52A of the Act.

Subdivision 3D.2—Procedure if proposed amendment referred to expert advisory committee

42ZCZJ Application

(1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:

(a) if:

(i) a person applies to the Secretary under section 52EAA of the Act to amend the current Poisons Standard; and

(ii) the Secretary decides to refer the proposed amendment to an expert advisory committee; or

(b) if the Secretary decides:

(i) to amend the current Poisons Standard on his or her own initiative; and

(ii) to refer the proposed amendment to an expert advisory committee.

Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.

42ZCZK Proposed amendment to be referred to expert advisory committee

(1) The Secretary must publish, in a manner the Secretary considers appropriate, a notice:

(a) specifying the expert advisory committee to which the proposed amendment will be referred; and

(b) specifying the date of the meeting of the committee; and

(d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).

(2) The first closing date must be at least 20 business days after publication of the notice.

(3) The date of the meeting must be at least 10 business days after the first closing date.

42ZCZL Consideration of public submissions

(1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:

(a) address a matter mentioned in section 52E of the Act; and

(b) are relevant to the proposed amendment.

(2) The committee is not required to consider a public submission received after the first closing date.

(3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.

(4) The Secretary must not publish any information that the Secretary considers to be confidential information.

42ZCZM Committee to advise Secretary

After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.

42ZCZN Interim decision of Secretary

After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.

42ZCZO Secretary may make final decision if no interim decision required

(1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).

(2) The Secretary must comply with regulation 42ZCZS after making the final decision.

42ZCZP Call for further submissions

(1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:

(a) setting out the interim decision and the reasons for making the interim decision; and

(b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and

(c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and

(d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.

(2) The second closing date must be at least 10 business days after publication of the notice.

42ZCZQ Reconsideration of interim decision

(1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:

(a) consider all public submissions (the relevant submissions) made by the second closing date that:

(i) address a matter mentioned in section 52E of the Act; and

(ii) are relevant to the Secretary’s interim decision; and

(b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).

(2) In reconsidering the interim decision, the Secretary:

(a) may request advice from any committee or any person; and

(b) is not required to engage in further public consultation.

(3) The Secretary need not consider a public submission made after the second closing date.

(4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.

(5) The Secretary must not publish any information that the Secretary considers to be confidential information.

42ZCZR Final decision if there is an interim decision

The Secretary may make a final decision by confirming, varying or setting aside the interim decision only:

(a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or

(b) if there are no such submissions or advice.

42ZCZS Publication of final decision

After making a final decision under regulation 42ZCZR or 42ZCZO, the Secretary must:

(a) publish, in a manner that the Secretary considers appropriate:

(i) the decision; and

(ii) the reasons for the decision; and

(iii) the date of effect of the decision; and

(b) if the decision is to amend the current Poisons Standard—make the amendment.

Note: The Secretary must comply with section 52E of the Act when amending the current Poisons Standard.

Subdivision 3D.3—Procedure if proposed amendments not referred to expert advisory committee

42ZCZT Application

This Subdivision applies if the Secretary:

(a) receives an application under section 52EAA of the Act to amend the current Poisons Standard; and

(b) decides not to refer the proposed amendment to an expert advisory committee.

Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.

42ZCZU Final decision without interim decision

(1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.

(2) The Secretary must comply with regulation 42ZCZX after making the final decision.

42ZCZV Interim decision required if Secretary decides not to amend as requested

If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:

(a) make an interim decision on the application having regard to the information provided by the applicant; and

(b) give the applicant a written notice:

(i) setting out the interim decision and the reasons for the decision; and

(ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.

42ZCZW Final decision if there is interim decision

If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:

(a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or

(b) if no submission is received from the applicant within that time.

42ZCZX Publication of final decision

After making a final decision under regulation 42ZCZU or 42ZCZW, the Secretary must:

(a) publish, in a manner that the Secretary considers appropriate:

(i) the decision; and

(ii) the reasons for the decision; and

(iii) the date of effect of the decision; and

(b) if the decision is to amend the current Poisons Standard—make the amendment.

Note: The Secretary must comply with section 52E of the Act when amending the current Poisons Standard.

Part 7—Charges for registration, listing and inclusion, licences, exemptions, costs and fees

Division 1—Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences

Subdivision 1—Preliminary

43AAA Meaning of turnover and when turnover is of low value

(1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.

(2) For this Division (other than Subdivision 3) and subject to regulation 43AABB:

(a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and

(b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.

Subdivision 1A—Time for payment of certain annual charges

43AAB Time for payment of certain annual charges

Entry of goods in Register commencing in financial year

(1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:

(a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or

(b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.

Entry of goods in Register commencing before start of financial year

(2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.

Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:

(a) the person is exempt from liability to pay the charge for that financial year under Subdivision 2; or

(b) the Secretary has waived the charge for that financial year under regulation 43AAH.

Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.

Subdivision 2—Exemption from liability to pay certain annual charges—therapeutic goods other than IVD devices

43AAAA Application

This Subdivision does not apply to IVD devices.

43AABA Purpose of this Subdivision

For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.

43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015

(1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.

(2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.

(3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:

(a) low value turnover;

(b) turnover.

43AAC Exemption from liability to pay certain annual charges—2015‑16 financial year

Therapeutic goods other than biologicals

(1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.

Entry of goods in Register commencing in 2015‑2016 financial year

(2) The requirements in this subregulation are met if:

(a) the registration, listing or inclusion in the Register of the goods commenced in the 2015‑16 financial year; and

(b) the person’s turnover of the goods for the 2015‑16 financial year is of low value; and

(c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

Entry of goods in Register commencing on or after 1 May 2015 and on or before 30 June 2015

(3) The requirements in this subregulation are met if:

(a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and

(b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and

(d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and

(e) the person’s turnover of the goods for the 2015‑16 financial years was of low value; and

(f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

Entry of goods in Register commencing on or after 1 July 2014 and on or before 30 April 2015

(4) The requirements in this subregulation are met if:

(a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and

(b) either:

(i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or

(ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and

(e) the person’s turnover of the goods for the 2015‑16 financial years was of low value; and

Entry of goods in Register commencing on or before 30 June 2014

(5) The requirements in this subregulation are met if:

(a) the registration, listing or inclusion in the Register of the goods commenced on or before 30 June 2014; and

(b) for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015, either:

(d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and

(e) the person’s turnover of the goods for the 2015‑16 financial years was of low value; and

Inclusion in Register of certain joint replacement medical devices on or after 1 July 2014 and on or before 30 June 2015

(5A) The requirements in this subregulation are met if:

(a) the therapeutic goods are a joint replacement medical device; and

(b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and

(c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and

(d) the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and

(e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and

(f) the person’s turnover of the medical device for the 2015‑16 financial year was of low value; and

(g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.

Inclusion in Register of certain joint replacement medical devices on or before 30 June 2014

(5B) The requirements in this subregulation are met if:

(a) the therapeutic goods are a joint replacement medical device; and

(b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and

(c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and

(d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and

(f) the person’s turnover of the medical device for the 2015‑16 financial year was of low value; and

Biologicals

(6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:

(a) the inclusion of the biological in the Register commenced in the 2015‑16 financial year; and

(b) the person’s turnover of the goods for the 2015‑16 financial year is of low value; and

Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.

Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.

Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.

Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.

43AAD Exemption from liability to pay certain annual charges—financial years commencing on or after 1 July 2016

A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:

(a) either:

(i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or

(ii) the registration, listing or inclusion in the Register of the goods commenced in the current financial year;

(b) the person’s turnover of the goods for the current financial year is of low value;

(c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.

Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.

Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.

Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.

Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.

43AAE Exemption from liability to pay certain annual charges—late notice that turnover was of low value

(1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.

(2) The person may, on or before 15 September in the next financial year, give the Secretary, in writing:

(a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and

(b) a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and

(c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.

Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

(3) The documents given under subregulation (2) must be accompanied by the fee payable.

(4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:

(a) the notice referred to in paragraph (2)(a); and

(b) the declaration referred to in paragraph (2)(b); and

(c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and

(d) the fee referred to in subregulation (3).

(5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.

(6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:

(a) states that the person is liable to pay the charge for the relevant financial year; and

(b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:

(i) the person did not give the documents to the Secretary by the required date;

(ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);

(iii) the documents were not accompanied by the correct fee; and

43AAF Person may notify Secretary that turnover of goods for financial year will not be of low value

(1) This regulation applies in relation to the following:

(a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;

(b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;

(c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.

(2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.

(3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.

Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).

43AAG Secretary may notify person that annual charge is payable if turnover is not of low value

Goods entered in Register at any time in 2015‑16 financial year

(1) If:

(a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and

(b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and

(c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and

(d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;

the Secretary must give the person a written notice in accordance with subregulation (2).

(2) A notice given to a person under subregulation (1) must:

(a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:

(i) for the 2015‑16 financial year; or

(ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and

(b) specify the date on which the relevant charge, or charges, become payable.

Goods entered in Register at any time in financial year commencing on or after 1 July 2016

(3) If:

(a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and

(b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and

(c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and

(d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;

the Secretary must give the person a written notice in accordance with subregulation (4).

(4) A notice given to a person under subregulation (3) must:

(a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:

(i) for the relevant financial year; or

(b) specify the date on which the relevant charge, or charges, become payable.

Subdivision 2A—Exemption from liability to pay annual charge—IVD devices

43AAGA Purpose of this Subdivision

For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.

43AAGB Exemption from liability to pay annual charge—2017‑18 financial year

Inclusion of IVD device in Register commencing in 2017‑18 financial year

(1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:

(a) the inclusion of the device in the Register commenced in the 2017‑18 financial year; and

(b) the person’s turnover of the device for the 2017‑18 financial year is of low value; and

(c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.

Inclusion of IVD device in Register on or before 30 June 2017

(2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:

(a) the inclusion of the device in the Register commenced on or before 30 June 2017; and

(b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and

(c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and

(d) the person’s turnover of the device for the 2017‑18 financial year was of low value; and

(e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.

Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.

Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.

Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.

Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.

43AAGC Exemption from liability to pay annual charge—financial years commencing on or after 1 July 2018

A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:

(a) either:

(i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or

(ii) the inclusion in the Register of the device commenced in the current financial year;

(b) the person’s turnover of the device for the current financial year is of low value;

(c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.

Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.

Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.

Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.

43AAGD Exemption from liability to pay annual charge—late notice that turnover was of low value

(1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.

(2) The person may, on or before 15 September in the next financial year, give the Secretary, in writing:

(a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and

(b) a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and

(c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).

Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

(3) The documents given under subregulation (2) must be accompanied by the fee payable.

(4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:

(a) the notice referred to in paragraph (2)(a); and

(b) the declaration referred to in paragraph (2)(b); and

(c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and

(d) the fee referred to in subregulation (3).

(a) states that the person is liable to pay the charge for the relevant financial year; and

(b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:

(i) the person did not give the documents to the Secretary by the required date;

(ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);

(iii) the documents were not accompanied by the correct fee; and

43AAGE Person may notify Secretary that turnover of IVD device for financial year will not be of low value

(1) This regulation applies in relation to the following:

(a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;

(b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.

(2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.

Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).

43AAGF Secretary may notify person that annual charge is payable if turnover is not of low value

IVD device entered in Register at any time in 2017‑18 financial year

(1) If:

(a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and

(b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and

(c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and

(d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;

the Secretary must give the person a written notice in accordance with subregulation (2).

(2) A notice given to a person under subregulation (1) must:

(a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:

(i) for the 2017‑18 financial year; or

(ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and

(b) specify the date on which the relevant charge, or charges, become payable.

IVD device entered in Register at any time in financial year commencing on or after 1 July 2018

(3) If:

(a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and

(b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and

(c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and

(d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;

the Secretary must give the person a written notice in accordance with subregulation (4).

(4) A notice given to a person under subregulation (3) must:

(a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:

(i) for the relevant financial year; or

(b) specify the date on which the relevant charge, or charges, become payable.

Subdivision 2B—Waiver of certain annual charges

43AAGG Purpose of Subdivision

For section 44A of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.

43AAH Waiver of certain annual charges

Scope

(1) This regulation applies in relation to a person who is liable to pay:

(a) an annual registration charge for registered goods that are medicines; or

(b) an annual charge for inclusion in the Register for a financial year of:

(i) a biological; or

(ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or

(iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.

Application for waiver of charge

(2) The person may apply to the Secretary, in writing, for the charge to be waived for a financial year.

(3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:

(a) be made:

(i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and

(ii) in any other case—at any time during the relevant financial year; and

(b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).

Note 1: No application fee is payable.

Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Decision by Secretary

(4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:

(a) to waive the charge for the financial year; or

(b) to refuse to waive the charge for the financial year.

(5) In considering the application, the Secretary:

(a) must take into account the information referred to in paragraph (3)(b); and

(b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.

(6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.

(7) The Secretary may decide to waive the charge for a financial year only if the Secretary is satisfied that:

(a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and

(b) it is in the interest of public health for the entry in relation to the goods to remain on the Register; and

(c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.

(8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:

(a) the population who use the goods;

(b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;

(i) obtaining the goods through alternative means; or

(ii) the use of alternative goods;

(d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.

(9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).

Notice of decision

(10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.

(11) If the decision is to refuse to waive the charge for the financial year, the notice under subregulation (10) must:

(a) set out the reasons for the decision; and

(b) specify the date on which the charge for the financial year becomes payable.

Period during which decision has effect

(12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.

(13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.

Subdivision 3—Charges for licensing

43AAJ Licensing charge—reduction in certain circumstances

(1) This regulation applies to a person if:

(a) the person is required to hold a licence under Part 3‑3 of the Act; and

(b) the person’s turnover of therapeutic goods is not more than $97,900 in a financial year.

(2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.

Division 2—Fees and costs

43 Fees

(1) Subject to the other provisions of this Part:

(a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and

(aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and

(b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.

(2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:

(a) an application to carry out steps in the manufacture of therapeutic goods at particular premises; or

(b) the inspection of licensed manufacturing premises for the purposes of section 40 of the Act;

the fee that is the greatest applicable fee is the only fee that applies in respect of that application or inspection.

43A When is no application fee payable?

Certain applications to transfer entries of kinds of medical devices

(2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.

Certain applications for the listing of medicines

(4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:

(a) the application is for the listing of medicine (the relisted medicine) under section 26A of the Act; and

(b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and

(c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and

(d) the application is made within the period of 18 months beginning on 6 March 2018.

43AA Fee for evaluation—refund in certain circumstances

If:

(a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and

(b) the Secretary has notified the applicant of the decision; and

then 25% of the evaluation fee must be refunded to the applicant.

43AB Circumstances in which inspection fee covered by annual charge

(1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.

(2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.

(3) In this regulation:

inspection means an inspection in relation to a metropolitan site.

43AC Refund of fees where no evaluation undertaken—registered OTC medicines

(1) This regulation applies if:

(a) a person makes an application of a kind mentioned in item 6 of the table in Part 3 of Schedule 9; and

(b) the person has paid the application fee required under that item in respect of the application; and

(2) The Secretary must refund to the person the following amount:

(a) for a C2 (section 9D) application—$4,000;

(b) for a C3 (section 9D) application—$6,710;

43ACA Refund of fees where no evaluation undertaken—registered complementary medicines

(1) This regulation applies if:

(a) a person makes an application of a kind mentioned in item 2, 3 or 4 of the table in Part 4 of Schedule 9; and

(b) the person has paid the application fee required under the item in respect of the application; and

(2) The Secretary must refund to the person the following amount:

(a) for an RCMC2 (section 9D) request—$4,040;

(b) for an RCMC3 (section 9D) request—$6,310;

43AD Fee for therapeutic goods (priority applicant) determination application—refund in certain circumstances

(1) This regulation applies if:

(a) a person applies to the Secretary under regulation 16H to designate a medicine as an orphan drug; and

(b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and

(d) after the person pays the fee, the Secretary designates the medicine as an orphan drug under regulation 16J.

(2) The Secretary must refund the fee to the person (whether or not the Secretary makes the determination).

43AE Fee for application for provisional determination relating to medicine—refund in certain circumstances

(1) This regulation applies if:

(a) a person applies to the Secretary under regulation 16H to designate a medicine as an orphan drug; and

(b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and

(c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and

(d) after the person pays the fee, the Secretary designates the medicine as an orphan drug under regulation 16J.

(2) The Secretary must refund the fee to the person (whether or not the Secretary makes the determination).

43AF Fee for request for variation of registered complementary medicines—refund in certain circumstances

If:

(a) a person (the applicant) makes a request under section 9D of the Act; and

(b) the request is:

(i) an RCMC2 (section 9D) request; or

(ii) an RCMC3 (section 9D) request; or

(iii) an RCMC4 (section 9D) request; and

(c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;

then 25% of the application fee must be refunded to the applicant.

44 Testing of samples—recovery of costs

If a person asks the Department to analyse a sample of goods, the costs incurred by the Department in carrying out that analysis are recoverable from that person as a debt due to the Commonwealth.

45 Waiver or reduction of fees

Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable

(1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:

(a) is in the interest of public health; and

(b) would not be commercially viable for the sponsor of the goods if the full amount of the fee were paid.

Waiver or reduction of evaluation fee for certain goods—goods with same active ingredient and common information

(2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:

(a) the goods to which each application relates contain the same active ingredient;

(b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.

Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information

(3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:

(a) the application is of a kind mentioned in subregulation (3B); and

(b) the applicant makes one or more additional applications of the same kind; and

(d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.

(3B) The applications are as follows:

(a) an L(A)1 application;

(b) an L(A)2 application;

(d) an RCM1 application;

(e) an RCM2 application;

(f) an RCM3 application;

(g) an RCM4 application;

(h) an RCM5 application.

Waiver or reduction of evaluation fees for certain goods—abridged evaluation procedure

(4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):

(a) to register goods; or

(aa) to list goods under section 26AE of the Act; or

(b) in relation to registered goods that are a medicine—to vary the information entered in the Register; or

(d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;

if the Secretary has information relating to the goods that enables the evaluation procedure to be abridged.

Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure

(4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:

(a) supply of the goods in Australia is necessary because of a public health emergency; and

(b) the waiver or reduction is necessary to enable the goods to be supplied in Australia; and

Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure

(5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:

(a) the medicine is a product of a kind specified in Part 1 of Schedule 10; and

(b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and

(i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and

(ii) neither non‑clinical nor quality data needs to be evaluated in the evaluation of the medicine for registration; and

(d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.

(6) The Secretary may:

(a) reduce the application fees specified in Schedule 9 that are payable in relation to the application to $1,100; and

(b) reduce the evaluation fees specified in Schedule 9 that are payable in relation to the application to $4,360.

Waiver of application and registration fees for designated orphan drugs

(12) The Secretary must waive the following fees:

(a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;

(b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;

(c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;

(d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.

45AA Payment of fees in instalments

(1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 6 or 7 in Part 2 of Schedule 9 or item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:

(a) the applicant has applied in writing to pay the amount in instalments; and

(b) the amount payable exceeds $10,000; and

(c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and

(d) any information or material to which subregulation (3) applies has been provided to the Secretary.

(2) An application under subregulation (1) must:

(a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and

(b) have with it documents or other material in support of the statement.

(3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.

(4) If the Secretary approves an application under subregulation (1):

(a) 50% of the fee is due for payment before the commencement of the evaluation of the application; and

(b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and

(i) if the application for evaluation is withdrawn—at the time of withdrawal; or

(ii) if the Secretary decides not to register the therapeutic device or refuses the application to include the biological in the Register—when the applicant is notified under subsection 25(3) or section 32DG of the Act; or

(iii) if the evaluation is completed—before the therapeutic device is registered or the biological is included in the Register.

(5) If:

(a) the Secretary approves an application under subregulation (1); and

(b) any amount of the fee payable by the applicant is not paid when it becomes due for payment;

the balance of the fee becomes due for payment.

(6) If the Secretary receives an application under subregulation (1), he or she must:

(a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and

(b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.

(7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.

Part 8—Miscellaneous

46A Delegation under the Act

(1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.

(2) For subsection 57(8) of the Act, the following positions are prescribed:

(a) First Assistant Secretary, Medicines Regulation Division;

(b) First Assistant Secretary, Medical Devices and Product Quality Division;

(d) each position classified as Medical Officer Class 5, Health Products Regulation Group.

46 Release of information

(1) In this regulation, therapeutic goods information has the same meaning as in section 61 of the Act.

(2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:

(a) whether the goods are included in the Register and, if so:

(i) the registration number, listing number, biological number or device number of the goods; and

(ii) the date when the goods were registered, listed or included in the Register; and

(iii) the class in which the goods are included in the Register;

(b) the name of the goods and the name and address of the sponsor of the goods;

(d) if the goods are supplied in a sterile state, the type of sterilisation used;

(e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:

(i) the quantity of goods to be in the primary pack; and

(ii) the entry relating to the goods in the Poisons Standard; and

(iii) the indications for the goods; and

(iv) the dosage form of the goods and their physical appearance; and

(v) the names and quantities of therapeutically active substances in the goods; and

(vi) the presence or absence of any specific excipient in the goods; and

(vii) the routes of administration of the goods; and

(viii) the type of container in which the goods are to be packed; and

(f) if the goods are a kind of medical device:

(i) the intended purpose of the device; and

(ii) the device nomenclature system code specified for the device under subsection 41BE(3) of the Act; and

(iii) the medical device classification applying to the device;

(g) whether the goods are a designated orphan drug;

(h) if the goods are a biological—which class.

(4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.

47 Delegation—powers and functions under these Regulations

(1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.

(2) The delegation must be by instrument signed by the Secretary.

(3) Nothing in subregulation (1) affects the Secretary’s power to delegate a power or function of the Secretary under regulation 5Q.

47A Delegation—powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act

(1) In this regulation:

delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:

(a) paragraph 19(1)(a), relating to specified therapeutic goods;

(b) paragraph 32CK(1)(d), relating to specified biologicals;

(2) A delegation may only be to a person who:

(a) is a medical practitioner registered in a State or Territory and employed by an institution that has an ethics committee; and

(b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.

(3) If:

(a) a person proposes another person under paragraph (2)(b) as a person to be a delegate; and

(b) that other person becomes a delegate;

the first‑mentioned person must supervise each approval that the delegate grants under the delegation.

(4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.

(5) A delegation may be made for the purpose of allowing the delegate to grant an approval in relation to:

(a) a particular item of therapeutic goods; or

(b) a particular class of therapeutic goods; or

(d) a particular class of biologicals; or

(e) a particular medical device; or

(f) a particular kind of medical device;

for treating a specific illness or condition.

(6) A delegate may grant an approval under a delegation only if:

(a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and

(b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.

47B Provision of information concerning medicines, biologicals and medical devices

(1) The following persons must provide a report to the Secretary every 6 months:

(a) a delegate under subsection 57(3) of the Act;

(b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;

(i) an exemption under section 18, 32CA or 41HA of the Act;

(ii) an approval under section 19, 32CK or 41HB of the Act;

(iii) an authority under section 19, 32CM or 41HC of the Act.

(2) The report must be in a form approved by the Secretary.

(3) A report by a person mentioned in paragraph (1)(a) must:

(a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and

(b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.

(4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.

(5) A report by a sponsor of therapeutic goods must: