Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This regulation amends the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 and relates to recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation, conducted in 2014-15 and agreed to by the Australian Government in its response to the Review.
Administered by: Health
Registered 30 Jun 2017
Tabling HistoryDate
Tabled HR08-Aug-2017
Tabled Senate08-Aug-2017
Date of repeal 05 Dec 2017
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

 

Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017

I, General the Honourable Sir Peter Cosgrove AK MC (Ret’d), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 27 June 2017

Peter Cosgrove

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health

 

 

 

 

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Variation of entries in Register                                                                                   2

Part 1—Registered complementary medicines and registered OTC medicines         2

Therapeutic Goods Regulations 1990                                                                                               2

Part 2—Prescription medicines                                                                                                           5

Therapeutic Goods Regulations 1990                                                                                               5

Schedule 2—Exemptions                                                                                                                            13

Therapeutic Goods (Medical Devices) Regulations 2002                                                           13

Therapeutic Goods Regulations 1990                                                                                             14

Schedule 3—Permissible ingredients                                                                                                  16

Therapeutic Goods Regulations 1990                                                                                             16

Schedule 4—Approval of medicines                                                                                                   17

Therapeutic Goods Regulations 1990                                                                                             17

Schedule 5—Record‑keeping etc.                                                                                                         22

Therapeutic Goods Regulations 1990                                                                                             22

Schedule 6—Public notification and recalls                                                                                   23

Therapeutic Goods (Medical Devices) Regulations 2002                                                           23

Therapeutic Goods Regulations 1990                                                                                             23

Schedule 7—Orphan drugs                                                                                                                      24

Therapeutic Goods Regulations 1990                                                                                             24

Schedule 8—Miscellaneous amendments                                                                                         29

Therapeutic Goods (Medical Devices) Regulations 2002                                                           29

Therapeutic Goods Regulations 1990                                                                                             31

Schedule 9—Transitional provisions                                                                                                  32

Therapeutic Goods Regulations 1990                                                                                             32

 


1  Name

                   This instrument is the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

1 July 2017.

1 July 2017

2.  Schedule 1, Part 1

1 July 2017.

1 July 2017

3.  Schedule 1, Part 2

1 January 2018.

4 December 2017

4.  Schedules 2 to 9

1 July 2017.

1 July 2017

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under the Therapeutic Goods Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Variation of entries in Register

Part 1Registered complementary medicines and registered OTC medicines

Therapeutic Goods Regulations 1990

1  After regulation 10

Insert:

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 Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected (as in force on the day this regulation commences) in relation to the code listed in column 3 of the item are satisfied.

Note:          Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected can be found on the Therapeutic Goods Administration website at http://www.tga.gov.au.

 

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

2  Clause 3 of Schedule 9 (table item 2A, column 2)

After “section 9D”, insert “(other than subsection 9D(2C)”.

3  Clause 3 of Schedule 9 (after table item 2CA)

Insert:

 

2CB

Fee for a request under subsection 9D(2C) of the Act (other than a request to which item 2CC or 2CD applies) to make one or more variations of one or more entries in the Register in relation to a medicine—for each entry

780

2CC

Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register that each relate to a registered complementary medicine—for each group of up to 7 entries

780

2CD

Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register that each relate to a registered OTC medicine—for each group of up to 7 entries

780

Part 2Prescription medicines

Therapeutic Goods Regulations 1990

4  Regulation 2

Insert:

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.

5  After regulation 10AAA

Insert:

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

             (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 Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected (as in force on the day this regulation commences) in relation to the code listed in column 3 of the item are satisfied.

Note:          Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected can be found on the Therapeutic Goods Administration website at http://www.tga.gov.au.

 

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

6

A minor change to the manufacture of an active pharmaceutical ingredient of the medicine, or an intermediate of such an ingredient, if the change does not affect any step taken to sterilise the ingredient or intermediate

AMMC

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

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

             (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 Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected (as in force on the day this regulation commences) in relation to the code listed in column 3 of the item are satisfied.

Note:          Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected can be found on the Therapeutic Goods Administration website at http://www.tga.gov.au.

 

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

6  Clause 3 of Schedule 9 (table item 2CB, column 2)

Omit “item 2CC or 2CD”, substitute “item 2CC, 2CD or 2CE”.

7  Clause 3 of Schedule 9 (after table item 2CD)

Insert:

 

2CE

Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register if:

(a) each entry relates to a prescription medicine or a biological medicine; and

(b) 2 or more of those medicines have the same active ingredient

The sum of:

(a) for each group of entries relating to medicines with the same active ingredient—780; and

(b) for any other entry—780

Schedule 2Exemptions

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Regulation 7.7

Omit “section 41HC”, substitute “subsection 41HC(1)”.

2  At the end of Division 7.3 of Part 7

Add:

7.8  Information to be notified in relation to supply of certain medical devices

                   For the purposes of paragraph 41HC(6C)(b) of the Act, the information that must be contained in a notification under subsection 41HC(6B) of the Act in relation to the supply by a health practitioner of a medical device 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 device was supplied;

                     (c)  each intended use of the device in relation to which the device was supplied;

                     (d)  the product name of the device;

                     (e)  the name of the manufacturer of the device;

                      (f)  a brief description of the device including whether the device is a variant;

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

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

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

3  Subregulation 8.2(2)

Omit “20 working days after signing it”, substitute “28 days after the use of the exempt device to which the statement relates”.

4  Subclause 8(3) of Schedule 3A (paragraph (c) of the definition of authorised person)

Omit “section 41HC”, substitute “subsection 41HC(1)”.

5  Subclause 8(3) of Schedule 3A (at the end of the definition of authorised person)

Add:

               ; or (d)  for an authority given by rules made under subsection 41HC(6) of the Act—a health practitioner included in the class of health practitioners specified in the rules.

6  Dictionary

Insert:

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

Therapeutic Goods Regulations 1990

7  Regulation 2

Insert:

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

8  Subregulation 12A(3)

After “subparagraph (2)(a)(iii)”, insert “in relation to a medicine or biological to be given to a person”.

9  Subregulation 12A(3)

Omit “4 weeks of signing it”, substitute “28 days after the medicine or biological is given to the person”.

10  Regulation 12B (heading)

Repeal the heading, substitute:

12B  Exemptions for certain uses—medicines and therapeutic devices

11  At the end of regulation 12B

Add:

             (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;

                     (c)  each indication of the medicine 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.

12  Regulation 12C (heading)

Repeal the heading, substitute:

12C  Exemptions for health practitioners—biologicals

13  At the end of regulation 12C

Add:

             (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;

                     (c)  each indication of the biological 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.

14  Paragraph 47B(1)(c)

Omit “a person (a sponsor) to whom”, substitute “a sponsor of therapeutic goods in relation to which”.

15  Paragraph 47B(5)(b)

Omit “medical”, substitute “health”.

16  At the end of paragraph 47B(5)(b)

Add:

                    ; and (v)  to which rules made under subsection 19(7A), 32CM(7A) or 41HC(6) of the Act apply.

17  Schedule 5A (table item 1, column 2, after paragraph (c))

Insert:

(ca) authorised for supply under rules made under subsection 19(7A) or 32CM(7A) of the Act; or

18  Subclause 8(3) of Schedule 5B (paragraph (b) of the definition of authorised person)

Omit “or authority under section 19, 32CK or 32CM of the Act”, substitute “under subsection 19(1) or section 32CK of the Act, or the authority under subsection 19(5) or 32CM(1) of the Act,”.

19  Subclause 8(3) of Schedule 5B (after paragraph (b) of the definition of authorised person)

Insert:

                   (ba)  who is included in a class of health practitioners specified in rules made under subsection 19(7A) or 32CM(7A) of the Act; or

Schedule 3Permissible ingredients

  

Therapeutic Goods Regulations 1990

1  Clause 3 of Schedule 9 (table item 7C, column 2)

Omit “for a variation of a determination under subsection 26BD(1)”, substitute “under subsection 26BE(1) of the Act”.

2  Clause 3 of Schedule 9 (table item 7D, column 2)

Omit “for a variation of a determination under subsection 26BD(1)”, substitute “under subsection 26BE(1) of the Act”.

Schedule 4Approval of medicines

  

Therapeutic Goods Regulations 1990

1  Regulation 2

Insert:

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.

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

2  After Part 3B

Insert:

Part 3CTherapeutic 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;

                     (c)  either:

                              (i)  no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register; or

                             (ii)  if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register—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

                     (c)  the priority indication of the medicine.

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 effective application under section 23 of the Act for the registration of the medicine 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 23(2) of the Act for when an application under section 23 of the Act is effective.

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 is not effective; 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 23(2) of the Act for when an application under section 23 of the Act is effective.

             (2)  The revocation must be by written notice given by the Secretary to the priority applicant.

3  After regulation 43AC

Insert:

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

                     (c)  the person pays the fee prescribed in item 1B of Part 2 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).

4  At the end of subregulation 45(12)

Add:

                   ; (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.

5  Subregulation 48(1) (before paragraph (f) of the definition of initial decision)

Insert:

                    (ec)  subparagraph 16R(1)(b)(ii);

                   (ed)  subregulation 16T(1);

6  After subregulation 48(2)

Insert:

       (2AA)  Despite subregulation (2), only the following persons may make a request under that subregulation in relation to a therapeutic goods (priority applicant) determination:

                     (a)  if the initial decision was to refuse to make the determination—the person who applied for the determination;

                     (b)  if the initial decision was to revoke the determination—the priority applicant specified in the determination.

7  Clause 3 of Schedule 9 (after table item 1)

Insert:

 

1B

Application fee for the purposes of paragraph 25AAA(3)(d) of the Act for therapeutic goods (priority applicant) determination in relation to a medicine

12 300

8  Clause 3 of Schedule 9 (after paragraph (bc) of table item 2)

Insert:

 

 

(bca) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ab) of item 4

49 800

9  Clause 3 of Schedule 9 (after paragraph (bf) of table item 2)

Insert:

 

 

(bfa) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bd) of item 4

29 600

10  Clause 3 of Schedule 9 (table item 4, column 2, paragraph (a))

After “paragraph (aa)”, insert “or (ab)”.

11  Clause 3 of Schedule 9 (after paragraph (aa) of table item 4)

Insert:

 

 

(ab) a new prescription medicine in relation to which a therapeutic goods (priority applicant) determination is in force

199 000

12  Clause 3 of Schedule 9 (table item 4, column 2, paragraph (b))

Omit “or (bc)”, substitute “, (bc) or (bd)”.

13  Clause 3 of Schedule 9 (after paragraph (bc) of table item 4)

Insert:

 

 

(bd) a new indications medicine in relation to which a therapeutic goods (priority applicant) determination is in force

118 400

Schedule 5Record‑keeping etc.

  

Therapeutic Goods Regulations 1990

1  Regulation 15A

Omit “For paragraph 28(5)(e)”, substitute “For the purposes of paragraphs 28(5)(ca) and (e)”.

2  Regulation 15A

Omit “the requirements, if any,”, substitute “the record‑keeping requirements (if any) and the reporting requirements (if any)”.

3  Regulation 15A

Omit “Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines”, substitute “Pharmacovigilance Responsibilities of Medicine Sponsors”.

Schedule 6Public notification and recalls

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Amendments of listed provisions—recall

Omit “recover” and substitute “recall” in the following provisions:

                     (a)  subparagraph 1.4(3)(c)(ii) of Schedule 3;

                     (b)  subparagraph 3.4(2)(c)(ii) of Schedule 3;

                     (c)  subparagraph 4.4(3)(c)(ii) of Schedule 3;

                     (d)  subparagraph 5.4(3)(c)(ii) of Schedule 3;

                     (e)  subparagraph 6.5(2)(c)(ii) of Schedule 3;

                      (f)  paragraph 7.2(6)(b) of Schedule 3;

                     (g)  subparagraph 7.5(4)(c)(ii) of Schedule 3.

Therapeutic Goods Regulations 1990

2  Subregulation 3A(2)

Omit “recovery”, substitute “recall”.

Schedule 7Orphan drugs

  

Therapeutic Goods Regulations 1990

1  Regulation 2 (definition of designated orphan drug)

Omit “an orphan drug designated under subregulation 16J(2)”, substitute “a medicine in relation to which a designation under regulation 16J is in force”.

2  Regulation 2

Insert:

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

                     (c)  does not have the same dosage form as that other medicine.

3  Regulation 2

Repeal the following definitions:

                     (a)  definition of orphan drug;

                     (b)  definition of rare disease.

4  Part 3B

Repeal the Part, substitute:

Part 3BDesignated 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:

                              (i)  no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register; or

                             (ii)  if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register—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:

                              (i)  no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register; or

                             (ii)  if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register—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);

                     (c)  the dosage form of the medicine;

                     (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.

5  Paragraphs 45(12)(a) and (b)

Repeal the paragraphs.

6  Subregulation 48(1) (paragraph (e) of the definition of initial decision)

Repeal the paragraph, substitute:

                     (e)  subparagraph 16J(1)(b)(ii);

                    (ea)  paragraph 16L(3)(b);

                   (eb)  paragraph 16M(1)(b);

Schedule 8Miscellaneous amendments

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  At the end of Division 5.2 of Part 5

Add:

5.9  Conditions applying automatically—storage and transport of medical devices (Act s 41FN)

                   For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must ensure that, while the person has control over a device of that kind, the device is stored and transported in accordance with the manufacturer’s instructions for use of the device and any other information provided with the device by the manufacturer.

5.10  Conditions applying automatically—record‑keeping (Act s 41FN)

             (1)  For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must:

                     (a)  create a record of information of a kind referred to in regulation 5.8 that relates to that kind of device as soon as practicable after the person becomes aware of the information; and

                     (b)  create a record of information in relation to the distribution by the person of each device of that kind as soon as practicable after the distribution.

             (2)  A record created under subregulation (1) must be kept:

                     (a)  for 10 years if the record relates to one of the following kinds of device:

                              (i)  a Class AIMD medical device;

                             (ii)  a Class III medical device;

                            (iii)  a Class IIb medical device that is an implantable medical device;

                            (iv)  a Class 4 IVD medical device; or

                     (b)  for 5 years if the record relates to any other kind of device.

5.11  Conditions applying automatically—reporting (Act s 41FN)

             (1)  This regulation applies in relation to the following kinds of medical devices:

                     (a)  a Class AIMD medical device;

                     (b)  a Class III medical device;

                     (c)  a Class IIb medical device that is an implantable medical device;

                     (d)  a Class 4 IVD medical device.

             (2)  For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must, before 1 October after each reporting period for that kind of device, give the Secretary a report about that kind of device for the reporting period.

             (3)  The report must include the following:

                     (a)  if no device of that kind was supplied in Australia or a foreign country during the reporting period—a statement to that effect;

                     (b)  if the person became aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device—that information;

                     (c)  if the person did not become aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device—a statement to that effect.

             (4)  For the purposes of this regulation, each of the following is a reporting period for a kind of medical device:

                     (a)  the period:

                              (i)  beginning on the day when that kind of device is included in the Register; and

                             (ii)  ending at the end of the next 30 June;

                     (b)  each of the next 2 financial years.

5.12  Conditions applying automatically—notification of information relating to certain IVD medical devices (Act s 41FN)

             (1)  This regulation applies in relation to a kind of medical device specified in paragraph 5.3(1)(j).

             (2)  For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must give the Secretary a written notice if:

                     (a)  the person intends to import, supply or export a medical device of that kind; and

                     (b)  either of the following is not included in the Register:

                              (i)  the product name of the device;

                             (ii)  information in relation to the manufacturer’s intended purpose of the device.

             (3)  The notice must:

                     (a)  specify the information mentioned in paragraph (2)(b) that is not included in the Register; and

                     (b)  be given to the Secretary no later than 20 business days before the intended import, supply or export of the device.

2  Regulation 10.6A

Omit “paragraph 57(9)(b)”, substitute “subsection 57(9)”.

3  Paragraph 10.6A(c)

Omit “Regulatory Services Group”, substitute “Health Products Regulation Group”.

4  Part 1 of Schedule 4 (table item 1.3, column headed “Kinds of medical devices”, paragraph (d))

Omit “or laboratory testing procedures”, substitute “, evaluation or laboratory testing procedures”.

5  Part 1 of Schedule 4 (at the end of table item 1.3, column headed “Kinds of medical devices”)

Add:

(e) use in the manufacture of goods including therapeutic goods;

(f) testing performed on a specimen taken from a cadaver (except to assess whether a part of the cadaver is suitable for transfusion or transplantation)

6  Part 1 of Schedule 5 (before table item 1.7)

Insert:

 

1.6B

Request for the revocation of the cancellation of an entry of a kind of medical device from the Register:

Paragraph 41GLB(1)(d) of the Act

 

 

(a) if the request relates to one entry;

 

150

 

(b) if the request relates to more than one entry

 

150 for the first entry plus 50 for each additional entry

Therapeutic Goods Regulations 1990

7  Subregulation 46A(2)

Omit “paragraph 57(8)(b)”, substitute “subsection 57(8)”.

8  Clause 3 of Schedule 9 (before table item 6C)

Insert:

 

6BB

Application fee for a request, under subsection 30AA(1) of the Act, for the revocation of the cancellation of the registration or listing of therapeutic goods:

 

 

(a) if the request relates to one registration or listing;

150

 

(b) if the request relates to more than one registration or listing

150 for the first registration or listing plus 50 for each additional registration or listing

9  Part 2 of Schedule 9A (before table item 17)

Insert:

 

16B

Application fee for a request, under subsection 32GDA(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register:

 

 

(a) if the request relates to one entry;

$150

 

(b) if the request relates to more than one entry

$150 for the first entry plus $50 for each additional entry

Schedule 9Transitional provisions

  

Therapeutic Goods Regulations 1990

1  In the appropriate position in Part 9

Insert:

Division 5Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017

52  Definitions

                   In this Division:

2017 Amendment Regulations means the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017.

commencement day means the day on which Part 1 of Schedule 1 to the 2017 Amendment Regulations commences.

53  Transitional—continuing application of evaluation fees for variations of permissible ingredients determinations

             (1)  This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:

                     (a)  an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and

                     (b)  no decision had been made in relation to the application; and

                     (c)  the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.

             (2)  Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.

54  Transitional—existing orphan drug designations

             (1)  This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.

             (2)  The designation continues in force for 12 months beginning on the commencement day.

55  Transitional—pending orphan drug designation applications

             (1)  This regulation applies if, before the commencement day:

                     (a)  a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and

                     (b)  the application had not been finally determined.

             (2)  Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.

             (3)  If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):

                     (a)  the designation:

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

                             (ii)  remains in force for 12 months; and

                     (b)  while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.

56  Transitional—fee waivers in relation to certain designations

             (1)  This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.

             (2)  The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:

                     (a)  paragraphs 45(12)(c) and (d);

                     (b)  paragraph 46(2)(g);

                     (c)  items 1 to 2B in Part 1 of Schedule 3;

                     (d)  Part 3 of Schedule 3.