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Therapeutic Goods Amendment Regulations 2011 (No. 1)

Authoritative Version
  • - F2011L00434
  • No longer in force
SLI 2011 No. 30 Regulations as made
These Regulations amend the Therapeutic Goods Regulations 1990 to include biologicals or exclude biologicals from the scope of those provisions, to make consequential change and to provide for minor or technical amendments.
Administered by: Health
Registered 16 Mar 2011
Tabling HistoryDate
Tabled HR21-Mar-2011
Tabled Senate21-Mar-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Amendment Regulations 2011 (No. 1)1

Select Legislative Instrument 2011 No. 30

I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Therapeutic Goods Act 1989.

Dated 10 March 2011

QUENTIN BRYCE

Governor-General

By Her Excellency’s Command

CATHERINE KING


1              Name of Regulations

                These Regulations are the Therapeutic Goods Amendment Regulations 2011 (No. 1).

2              Commencement

                These Regulations commence on the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010.

3              Amendment of Therapeutic Goods Regulations 1990

                Schedule 1 amends the Therapeutic Goods Regulations 1990.


Schedule 1        Amendments

(regulation 3)

 

[1]           Regulation 2, after definition of CHCA

insert

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 2 biological means a biological that is:

                (a)    both:

                          (i)    processed using only one or more of the actions of minimal manipulation; and

                         (ii)    for homologous use; or

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

Class 3 biological means a biological that is:

                (a)    processed:

                          (i)    using a method in addition to any of the actions of minimal manipulation; and

                         (ii)    in a way that does not change an inherent biochemical, physiological or immunological property; or

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

Class 4 biological means a biological that is:

                (a)    processed:

                          (i)    using a method in addition to any of the actions of minimal manipulation; and

                         (ii)    in a way that changes an inherent biochemical, physiological or immunological property; or

               (b)    mentioned in Schedule 16 as a Class 4 biological.

[2]           Regulation 2, definition of designated therapeutic goods, paragraph (c)

omit

Poisons Standard.

insert

Poisons Standard; and

[3]           Regulation 2, definition of designated therapeutic goods, after paragraph (c)

insert

               (d)    biologicals.

[4]           Regulation 2, after definition of homoeopathic preparation

insert

homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with a biological that performs the same basic function in the recipient as in the donor.

[5]           Regulation 2, after definition of immediate family

insert

minimal manipulation means a process involving any of the following actions:

                (a)    centrifugation;

               (b)    trimming, cutting or milling;

                (c)    flushing or washing;

               (d)    refrigeration;

                (e)    freezing;

                (f)    freeze drying (of structural tissues only);

               (g)    the use of additives such as cryopreservatives, anticoagulants, antimicrobial agents;

               (h)    irradiation for the purpose of bioburden reduction;

                (i)    any other action that is similar to an action mentioned in paragraph (a), (b), (c), (d), (e), (f), (g) or (h).

[6]           Regulation 2, after definition of NFAA

insert

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.

[7]           Regulation 2, after definition of tuberculocide

insert

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

[8]           Regulation 10B

substitute

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

                (c)    medical devices.

         (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

                (c)    are a biological.

         (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.

[9]           After Division 2C.2

insert

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

         (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.

         (2)   If the person dies, that person’s legal personal representative:

                (a)    is taken to be the person in relation to whom the biological is included in the Register under that Part; and

               (b)    must notify the Secretary, in writing, of the death within 3 months after it occurred.

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

                (a)    is taken to be the person in relation to whom the biological is included in the Register under that Part; and

               (b)    must notify the Secretary, in writing, of the bankruptcy within 3 months after the person became bankrupt.

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

                (a)    is taken to be the person in relation to whom the biological is included in the Register under that Part; and

               (b)    must notify the Secretary, in writing, of the winding up within 3 months after the body corporate is wound up.

         (5)   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:

                (a)    notify the Secretary, in writing, of the new name of the person and the circumstance giving rise to it; and

               (b)    return the certificate of the inclusion of the biological in the Register given under subsection 32DB (3) or 32DF (3) of the Act.

         (6)   If the person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological, the person to whom the business or interest is transferred or assigned:

                (a)    is taken, to the extent of the business or interest transferred or assigned, 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 writing, of the transfer or assignment within 3 months after the transfer or assignment.

         (7)   If a person notifies the Secretary of an event mentioned in paragraph (2) (b), (3) (b), (4) (b) or (6) (b), or a change of name under subregulation (5), the person must give the Secretary sufficient documentary evidence to establish the matter asserted in the notification.

         (8)   If, under subregulation (5), the Secretary is notified of a new name for a person, the Secretary must:

                (a)    enter the new name in the Register as the name of the person in relation to whom the biological is included in the Register under that Part; and

               (b)    as soon as practicable after entering the new name, give to the person a new certificate of the inclusion of the biological in the Register under that Part.

         (9)   If, at any time, the Secretary becomes aware that he or she has not been informed of a change in the name of a person in accordance with subregulation (5), the Secretary may cancel the entry in the Register in relation to the biological.

       (10)   If, under this regulation, the Secretary changes the name of a person in relation to whom a biological is included in the Register under Part 3-2A of the Act or cancels an entry in the Register in relation to a biological, the Secretary must, as soon as practicable after changing the name or cancelling the entry:

                (a)    notify the person that the name has been changed or the entry in the Register has been cancelled; and

               (b)    ask the person to return to the Secretary the certificate of the inclusion of the biological in the Register given under subsection 32DB (3) or 32DF (3) of the Act.

       (11)   If a person receives a notice under subregulation (10), the person must return to the Secretary, as soon as practicable after receiving the notice, the certificate of the inclusion of the biological in the Register under that Part that was given before the change of name or cancellation.

Penalty:   5 penalty units.

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.

[10]         Part 3, heading

substitute

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

  

[11]         Regulation 12

substitute

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.

         (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.

[12]         Regulation 12A, heading

substitute

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

[13]         After subregulation 12A (1)

insert

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

[14]         Subregulation 12A (2)

after each mention of

medicine

insert

or biological

[15]         Regulation 12AAB, heading

substitute

12AAB   Disposal of unused emergency goods and unused emergency biologicals

[16]         Subregulation 12AAB (1)

substitute

         (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.

[17]         After subregulation 12AAB (2)

insert

         (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.

[18]         Regulation 12AA

omit everything before paragraph (a), insert

                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:

[19]         Subregulation 12AB (1)

omit

subsection 19 (1A)

insert

subsections 19 (1A) and 32CK (8)

[20]         Regulation 12AD

omit

subsection 19 (4A)

insert

subsections 19 (4A) and 32CL (1)

[21]         Regulation 12B, heading

substitute

12B         Exemptions for special and experimental uses — medicines

[22]         After regulation 12B

insert

12C         Exemptions for special and experimental uses — 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.

[23]         After regulation 16AA

insert

16AB      Specified periods

                For paragraphs 32DQ (1) (c) and (2) (c) of the Act, 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 biological 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 biological or another person — within 30 days after the person first becomes aware of the event or occurrence.

[24]         Part 3A, after Division 2

insert

Division 3              Class 2, Class 3 and Class 4 biologicals

16GB      Notification of acceptance or rejection of application

         (1)   This regulation applies to an application:

                (a)    under section 32DD of the Act that requires an evaluation to which regulation 16GC applies; and

               (b)    to which regulation 16GD applies.

         (2)   The Secretary must send a notification in writing to the applicant that states whether the application has been accepted or rejected.

         (3)   A notification must be sent within 40 days after the Secretary receives the application.

16GC      Periods within which certain evaluations must be made

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

         (2)   The evaluation must be completed within 365 days after the Secretary sends a notification to the applicant under regulation 16GB that indicates acceptance of the application for the evaluation.

16GD      Periods 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 asks 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)   The application must be decided, and notification given to the applicant, within 365 days after the Secretary sends a notification to the applicant under regulation 16GB that indicates acceptance or rejection of the application.

16GE      Failure to decide an application within specified time

                The failure to decide, within the time mentioned in subregulation 16GD (2), 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 32DD 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.

[25]         After Part 5

insert

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

                (c)    a nonconforming biological that is included in the Register under Part 3-2A of the Act is available; 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.

[26]         After subparagraph 34A (1) (a) (vi)    

insert

                       (vii)    matters relating to standards for biologicals;

[27]         Part 6, after Division 1E

insert

Division 1EA         Advisory Committee on Biologicals

39C         Establishment

                The Advisory Committee on Biologicals is established.

39D         Functions

         (1)   The committee’s functions are to advise and make recommendations to the Minister or Secretary about the following matters:

                (a)    inclusion of a biological in the Register under Part 3-2A of the Act;

               (b)    variation of an entry for a biological included in the Register under Part 3-2A of the Act;

                (c)    removal or continued inclusion of a biological in the Register under Part 3-2A of the Act;

               (d)    any other matter concerning a biological;

                (e)    any other matter referred to the committee by the Minister or Secretary (whether or not related to biologicals).

         (2)   The Minister or Secretary may require the committee to give its advice to other persons or bodies.

         (3)   The committee must publish its recommendations.

39E         Membership

         (1)   The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (2) and (3).

         (2)   Each member of the committee must have expertise in at least one of the following fields:

                (a)    infectious diseases;

               (b)    tissue products;

                (c)    blood products;

               (d)    cellular therapies, including tissue engineering;

                (e)    stem cell transplantation;

                (f)    organ and tissue transplantation;

               (g)    clinical expertise;

               (h)    epidemiology or biostatistics;

                (i)    toxicology;

                (j)    consumer issues.

         (3)   Membership of the committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).

[28]         Regulation 40

omit

1D and 1E.

insert

1D, 1E and 1EA.

[29]         Part 7, Division 1, Subdivision 1, heading

substitute

Subdivision 1              Charges for registration, listing and inclusion of medical devices and biologicals

[30]         Regulation 43AAB

substitute

43AAB   Definitions

                In this Subdivision:

approved person means a person who is a qualified accountant under section 88B of the Corporations Act 2001, but does not include:

                (a)    a person who, under this Subdivision, is required to submit to the Secretary a statement signed by an approved person; or

               (b)    an employee of that person.

existing entry, for a therapeutic good (other than a biological), means an entry for registration, listing or inclusion of the therapeutic good (other than a biological) in the Register that is not a new entry.

low value turnover means a turnover of not more than 15 times the annual registration charge, the annual listing charge or the annual charge for inclusion in the Register (other than the annual charge for inclusion in the Register of a biological under Part 3-2A of the Act) payable for a financial year.

new entry, for a therapeutic good (other than a biological), means an entry for registration, listing or inclusion of the therapeutic good (other than a biological) in the Register that commenced in the financial year.

turnover, for a therapeutic good (other than a biological), means gross dollar receipts (excluding GST) from sales of the therapeutic good (other than a biological) in Australia for a financial year, including retail and wholesale sales.

[31]         Subregulations 43AAC (1) and 43AAE (1)

after each mention of

therapeutic good

insert

(other than a biological)

[32]         Subregulation 43AAG (5)

omit

subregulaton

insert

subregulation

[33]         Subregulation 43 (1)

substitute

         (1)   Subject to the other provisions of this Part:

                (a)    the fee mentioned in column 3 of an item in Part 2 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 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.

[34]         Subregulations 45 (2) and (4)

omit

Schedule 9

insert

Schedules 9 and 9A

[35]         Paragraph 45 (4) (b)

omit

Register;

insert

Register; or

[36]         After paragraph 45 (4) (b)

insert

                (c)    to include goods in the part of the Register for biologicals; or

               (d)    for a biological included in the Register under Part 3-2A of the Act — to vary the information included in the Register;

[37]         Subregulation 45AA (1)

after

Schedule 9

insert

item 4, 5, 6, 10 or 11 in Schedule 9A

[38]         Subparagraph 46 (2) (a) (i)

omit

listing number

insert

listing number, biological number

[39]         Paragraph 46 (2) (e)

omit each mention of

medicines,

insert

medicines or biologicals,

[40]         Paragraph 46 (2) (e)

after

medicine

insert

or biological

[41]         Paragraph 46 (2) (g)

omit

drug.

insert

drug;

[42]         After paragraph 46 (2) (g)

insert

               (h)    if the goods are a biological — which class.

[43]         Regulation 47A, heading

substitute

47A         Delegation — powers under paragraphs 19 (1) (a), 32CK (1) (d) and 41HB (1) (d) of the Act

[44]         Subregulation 47A (1)

substitute

         (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;

                (c)    paragraph 41HB (1) (d), relating to a specified medical device or a kind of medical device.

[45]         Subregulation 47A (4)

omit

goods

insert

goods, biologicals or devices

[46]         Paragraph 47A (5) (b)

after

goods;

insert

or

[47]         After paragraph 47A (5) (b)

insert

                (c)    a particular biological; or

               (d)    a particular class of biologicals; or

                (e)    a particular medical device; or

                (f)    a particular kind of medical device;

[48]         Paragraphs 47A (6) (a) and (b)

substitute

                (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.

[49]         Regulation 47B, heading

substitute

47B         Provision of information concerning medicines, biologicals and medical devices

[50]         Paragraph 47B (1) (b)

substitute

               (b)    a person authorised under subsection 19 (5), 32CM (1) or 41HC (1) of the Act to supply a medicine, biological or medical device;

[51]         Paragraph 47B (3) (a)

omit

item of therapeutic goods (including medical devices)

insert

biological, kind of medical device and other item of therapeutic goods

[52]         Paragraph 47B (3) (b)

omit

medicines

insert

medicines, biologicals

[53]         Subregulation 47B (4)

omit

item of therapeutic goods (including medical devices)

insert

biological, kind of medical device and other item of therapeutic goods

[54]         Subparagraphs 47B (5) (b) (i) to (iv)

substitute

                          (i)    to which section 18, subsection 32CA (2) or section 41HA of the Act applies; and

                         (ii)    to which paragraph 19 (1) (a), 32CK (1) (d) or 41HB (1) (d) of the Act applies; and

                        (iii)    to which paragraph 19 (1) (b), 32CK (1) (e) or 41HB (1) (e) of the Act applies; and

                        (iv)    to which subsection 19 (5), 32CM (1) or 41HC (1) of the Act applies.

[55]         Subregulation 48 (1), definition of initial decision, after paragraph (d)

insert

             (da)    subregulation 10H (9);

[56]         Schedule 4, Part 1, item 2

omit

3 or 4, paragraph 7 (e) or (q) or item

insert

3, 4, 7 or

[57]         Schedule 4, Part 1, item 12

substitute

12

kits (to be known as medicine kits) consisting as follows:

   (a)  solely of medicines — if Part 3‑2 of the Act applies to any of the individual therapeutic goods contained in the kit;

  (b)  of medicines and biologicals — if:

         (i)   Part 3-2 of the Act applies to any of the individual therapeutic goods (other than biologicals) contained in the kit; and

        (ii)   Part 3-2A of the Act applies to any of the biologicals contained in the kit

[58]         Schedule 5, heading

substitute

Schedule 5        Therapeutic goods exempt from the operation of Parts 3-2 and 3-2A of the Act

(subregulation 12 (1))

  

[59]         Schedule 5, item 1, paragraph (b)

substitute

 

  (b)  for injections that contain material of human or animal origin — the goods are the subject of an approval under section 19 of the Act, or are insulin preparations; and

(ba)  for a biological — the biological is the subject of an approval under section 32CK of the Act; and

[60]         Schedule 5, item 7

substitute

7

manufacturing, laboratory and dispensary equipment used in the preparation of therapeutic goods

[61]         Schedule 5, item 9

substitute

9

medicines or biologicals that are starting materials used in the manufacture of therapeutic goods, except when:

   (a)  prepackaged for supply for other therapeutic purposes; or

  (b)  formulated as a dosage form

10

medicines that are blood and blood components manufactured by the holder of a licence to manufacture blood and blood components

[62]         Schedule 5A, heading

substitute

Schedule 5A      Therapeutic goods exempt from the operation of Parts 3-2 and 3-2A of the Act subject to conditions

(subregulation 12 (1A))

  

[63]         Schedule 5A, items 1 and 1A

substitute

1

Therapeutic goods imported into Australia that are held under the direct control of the sponsor, until the goods are:

   (a)  the subject of a notification under item 3; or

  (b)  approved for importation into Australia under subsection 19 (1) or 32CK (1) of the Act; or

   (c)  authorised for supply under subsection 19 (5) or 32CM (1) of the Act; or

  (d)  dispensed as a medicine or biological prescribed for a Category A patient within the meaning of subregulation 12A (5)

   (a)  the supply of the goods must be in accordance with the relevant notification, approval, authorisation or prescription; and

  (b)  the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and

   (c)  if the goods are not used within 12 months of importation:

         (i)   in the case of therapeutic goods other than therapeutic devices and biologicals — the goods must be destroyed within 1 month of the end of that period; and

        (ii)   in the case of therapeutic devices or biologicals — the devices or biologicals must be destroyed or returned to the consignor of the devices or biologicals within 1 month of the end of that period; and

  (d)  the sponsor must:

         (i)   keep records relating to the source and supply of the goods; and

        (ii)   if the goods are destroyed under paragraph (c), keep records relating to the destruction; and

       (iii)   if requested by the Secretary, give the records to the Secretary

1A

Therapeutic goods imported into Australia and held under the direct control of the sponsor, until a decision is made under section 25, 26, 26A, 32DB, 32DC, 32DF or 32DG of the Act about the goods

   (a)  the sponsor must:

         (i)   keep records about the source of the goods; and

        (ii)   if requested by the Secretary — supply the records to the Secretary; and

       (iii)   have lodged an application under section 23, 32DA or 32DD of the Act for the goods before their importation; and

  (b)  if the goods are not registered, listed, or included in the Register under Part 3‑2A of the Act:

         (i)   in the case of therapeutic goods other than therapeutic devices and biologicals — the goods must be destroyed; or

 

 

        (ii)   in the case of therapeutic devices or biologicals — the devices or biologicals must be destroyed or returned to the consignor of the devices or biologicals within 1 month of the decision not to register, list or include the devices or biologicals

[64]         Schedule 5A, item 3, paragraph (b)

omit

Schedule 9;

insert

Schedule 9 or item 17 of Schedule 9A;

[65]         Schedule 5A, item 3, paragraph (g)

omit

item

insert

item; and

[66]         Schedule 5A, item 3, after paragraph (g)

insert

  (h)  the goods are not any of the following:

         (i)   a Class 4 biological that has not received clinical trial approval for an equivalent indication from a national regulatory agency with comparable regulatory requirements;

        (ii)   a Class 4 biological that does not have a history of previous usage that is supported by clinical evidence received by the TGA

[67]         Schedule 5A, item 4, paragraph (g)

omit

device —

insert

device or biological —

[68]         Schedule 5A, item 5

omit

item 3,

insert

item 3 or biologicals,

[69]         Schedule 5A, item 8

omit

device —

insert

device or biological —

[70]         Schedule 5A, item 9

substitute

9

Unused emergency goods or unused emergency biologicals directed by the Secretary, under clause 7 of Schedule 5B, to be exported

the provisions of Schedule 5B continue to apply to the goods or biologicals, as if the goods or biologicals were not exempt from the operation of section 30G or 32CG of the Act

[71]         Schedule 5A, items 10 to 12

omit

device —

insert

device or biological —

[72]         Schedule 5B, heading

substitute

Schedule 5B      Disposal of unused emergency goods and unused emergency biologicals

(regulation 12AAB)

  

[73]         Schedule 5B, after clause 1

insert

1A           Early cessation of exemption — notice of biologicals held

         (1)   A person who is given notice under paragraph 32CE (b) of the Act must give to the Secretary:

                (a)    notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and

               (b)    a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep.

         (2)   Subclause (1) must be complied with:

                (a)    if the notice under paragraph 32CE (b) of the Act is given before the exemption ceases to have effect for the biologicals — within 7 days after the exemption ceases; or

               (b)    in any other case — within 7 days after the notice is given.

[74]         Schedule 5B, after clause 2

insert

2A           Expiration of period of exemption — notice of biologicals held

                A person who has been importing, manufacturing, supplying or exporting biologicals under an exemption under subsection 32CB (1) of the Act must, within 7 days after the end of the period specified in the exemption under subsection 32CB (4), give to the Secretary:

                (a)    notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and

               (b)    a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep.

[75]         Schedule 5B, clause 3, heading

substitute

3              Storage and disposal of unused emergency goods and unused emergency biologicals

[76]         Schedule 5B, subclause 3 (1)

omit

must ensure that those goods

insert

or unused emergency biologicals must ensure that those unused emergency goods or unused emergency biologicals

[77]         Schedule 5B, paragraphs 3 (1) (a) to (c)

after each mention of

goods

insert

or biologicals

[78]         Schedule 5B, subclause 3 (2)

after

unused emergency goods

insert

or unused emergency biologicals

[79]         Schedule 5B, clause 4, heading

substitute

4              Direction for disposal of unused emergency goods and unused emergency biologicals

[80]         Schedule 5B, subclause 4 (1)

omit

to dispose of the goods

insert

or unused emergency biologicals to dispose of the unused emergency goods or unused emergency biologicals

[81]         Schedule 5B, clause 5, heading

substitute

5              Relocation of unused emergency goods and unused emergency biologicals

[82]         Schedule 5B, clause 5

after

unused emergency goods

insert

or unused emergency biologicals

[83]         Schedule 5B, clause 5

after

the goods

insert

or biologicals

[84]         Schedule 5B, clause 6, heading

substitute

6              Disposal of unused emergency goods and unused emergency biologicals — destruction

[85]         Schedule 5B, subclause 6 (1)

after

unused emergency goods

insert

or unused emergency biologicals

[86]         Schedule 5B, paragraphs 6 (1) (a) to (d)

after each mention of

goods

insert

or biologicals

[87]         Schedule 5B, paragraph 6 (1) (e)

omit

within

insert

for unused emergency goods — within

[88]         Schedule 5B, after paragraph 6 (1) (e)

insert

              (ea)    for unused emergency biologicals — within 12 months after the exemption ceases to have effect in relation to the biologicals, the biologicals have not become (whether in relation to an indication for which the biologicals 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 biologicals under section 32CA of the Act; or

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

                        (iv)    biologicals that are the subject of an approval under section 32CO of the Act;

[89]         Schedule 5B, paragraph 6 (1) (f)

after each mention of

goods

insert

or biologicals

[90]         Schedule 5B, subclause 6 (2)

after each mention of

goods

insert

or biologicals

[91]         Schedule 5B, clause 7, heading

substitute

7              Disposal of unused emergency goods and unused emergency biologicals — export

[92]         Schedule 5B, subclause 7 (1)

after

unused emergency goods

insert

or unused emergency biologicals

[93]         Schedule 5B, subclauses 7 (2) and (3)

after each mention of

the goods

insert

or biologicals

[94]         Schedule 5B, clause 8, heading

substitute

8              Disposal of unused emergency goods and unused emergency biologicals — supply

[95]         Schedule 5B, subclause 8 (1)

omit

goods that have become (whether in relation to an indication for which the goods

insert

goods or unused emergency biologicals that have become (whether in relation to an indication for which the unused emergency goods or unused emergency biologicals

[96]         Schedule 5B, after paragraph 8 (1) (a)

insert

              (aa)    biologicals included in the Register under Part 3-2A of the Act; or

[97]         Schedule 5B, after paragraph 8 (1) (b)

insert

              (ba)    biologicals that are the subject of an approval or authority under section 32CK or 32CM of the Act; or

[98]         Schedule 5B, paragraph 8 (1) (c)

omit

Act.

insert

Act; or

[99]         Schedule 5B, after paragraph 8 (1) (c)

insert

               (d)    biologicals that are the subject of an approval under section 32CO of the Act.

[100]       Schedule 5B, subclause 8 (2)

after

goods

insert

or biologicals

[101]       Schedule 5B, subclause 8 (3), definition of authorised person, after paragraph (a)

insert

              (aa)    in relation to whom the biologicals are included in the Register under Part 3-2A of the Act; or

[102]       Schedule 5B, subclause 8 (3), definition of authorised person, paragraph (b)

omit

section 19

insert

section 19, 32CK or 32CM

[103]       Schedule 5B, subclause 8 (3), definition of authorised person, paragraph (c)

after

section 19A

insert

or 32CO

[104]       Schedule 5B, clause 9, heading

substitute

9              Owner to be paid for goods or biologicals supplied

[105]       Schedule 5B, clause 9

after each mention of

the goods

insert

or biologicals

[106]       Schedule 5B, clause 10, heading

substitute

10            Records about unused emergency goods and unused emergency biologicals

[107]       Schedule 5B, clause 10

after

unused emergency goods

insert

or unused emergency biologicals

[108]       Schedule 5B, subparagraphs 10 (a) (i) to (iv) and (c) (ii)

after

the goods

insert

or biologicals

[109]       Schedule 5B, clause 11

substitute

11            Failure to comply with this Schedule

                If a person who has control over any unused emergency goods or unused emergency biologicals has not complied with a provision of this Schedule, the Secretary may direct, in writing, that the unused emergency goods or unused emergency biologicals be destroyed by another person.

[110]       Schedule 8, items 2 and 3

omit

goods

insert

goods, other than biologicals,

[111]       Schedule 8, item 5

omit

a name and address or the registration or listing number of goods

insert

a name and address, the registration or listing number of goods, or the biological number of a biological

[112]       Schedule 9, heading

substitute

Schedule 9        Fees — therapeutic goods other than biologicals

(regulation 43)

  

[113]       After Schedule 9

insert

Schedule 9A      Fees — biologicals

(regulation 43)

Part 1          Interpretation of table

1              Definitions

                In this table:

major variation, for a biological, means a change to the entry of the biological in the Register for any of the following:

                (a)    a change requiring submission and evaluation of clinical data;

               (b)    extension of an indication;

                (c)    a new strength;

               (d)    a new route of administration;

                (e)    a change in the intended patient group;

                (f)    a change in dosage.

minor variation, for a biological, means a change (other than a change that is a major variation) to the entry of the biological in the Register for any of the following:

                (a)    a change requiring evaluation of quality and manufacturing information;

               (b)    a new manufacturing site;

                (c)    a change in specification;

               (d)    a change in container.

Part 2          Table of fees

Item

Matter

Fee

1

Application for inclusion of a Class 1 biological in the Register for paragraph 32DA (2) (d) of the Act

$900 for each application

2

Application for inclusion of a Class 2, Class 3 or Class 4 biological in the Register for paragraph 32DD (2) (e) of the Act

$900 for each application

3

Application for a manufacturing licence for paragraph 37 (1) (g) of the Act

$900 for each application

4

Evaluation of a Class 2 biological for inclusion in the Register for subsection 32DI (1) of the Act

$60 000 for each evaluation

5

Evaluation of a Class 3 biological for inclusion in the Register for subsection 32DI (1) of the Act

$120 000 for each evaluation

6

Evaluation of a Class 4 biological for inclusion in the Register for subsection 32DI (1) of the Act

$195 000 for each evaluation

7

Evaluation of an ingredient or component of a biological under regulation 16GF, for use in multiple biologicals (for which application for registration would later be made)

$19 400 for each evaluation

8

Application for variation to information about a biological included in the Register under subsection 9D (3AA) or (3A) of the Act

$900 for each application

9

Evaluation of a product dossier for variation to information of a Class 2 biological included in the Register under subsection 9D (3AA) or (3A) of the Act

$5 500 for each evaluation

10

Evaluation of a product dossier for a minor variation to information about a Class 3 or Class 4 biological included in the Register under subsection 9D (3AA) or (3A) of the Act

$14 500 for each evaluation

11

Evaluation of a product dossier for a major variation to information about a Class 3 or Class 4 biological included in the Register under subsection 9D (3A) of the Act

$28 500 for each evaluation

12

Inspection fee — initial manufacturing audit (Australia and overseas) for paragraphs 32DE (1) (e), 38 (1) (c) and 58 (3) (b) of the Act

$17 900 for each inspection

13

Inspection fee – subsequent Manufacturing Audit (Australia and overseas) for paragraphs 41 (1) (f) and 58 (3) (b) of the Act

$13 500 for each inspection

14

Inspection fee — in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia

$550 for each hour of preparation by each inspector

15

Inspection fee — in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia

Amount of costs and reasonable expenses of travel by each inspector, including costs for accommodation and allowance outside Australia

16

Evaluation fee for subsection 32CK (4) of the Act

$21 600 for each evaluation

17

Notification fee for a biological mentioned in item 3 of Schedule 5A

$280 for each evaluation

[114]       After Schedule15

insert

Schedule 16      Classes of biologicals

  

Note   This Schedule is reserved for future use.


Note

1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.