Federal Register of Legislation - Australian Government

Primary content

Regulations as made
This instrument amends the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to support the streamlining of applications for new ingredients for use in listed and assessed listed medicines, enhance the data protection scheme for such medicines, reduce regulatory burden and correct errors.
Administered by: Health
Registered 16 Apr 2021
Tabling HistoryDate
Tabled HR11-May-2021
Tabled Senate11-May-2021
To be repealed 12 Aug 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods Legislation Amendment (2021 Measures No. 1) Regulations 2021

I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.

Dated 15 April 2021

David Hurley

Governor‑General

By His Excellency’s Command

Greg Hunt

Minister for Health and Aged Care

 

 

 

  

  


Contents

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

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

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

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

Schedule 1—Amendments of Therapeutic Goods Regulations                                           2

Therapeutic Goods Regulations 1990                                                                                               2

Schedule 2—Amendments of Therapeutic Goods (Medical Devices) Regulations  3

Therapeutic Goods (Medical Devices) Regulations 2002                                                             3

 


1  Name

                   This instrument is the Therapeutic Goods Legislation Amendment (2021 Measures No. 1) Regulations 2021.

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

The day after this instrument is registered.

17 April 2021

2.  Schedule 1, items 1 and 2

At the same time as Schedules 5 and 6 to the Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021 commence.

19 April 2021

3.  Schedule 1, item 3

The day after this instrument is registered.

17 April 2021

4.  Schedule 2

The day after this instrument is registered.

17 April 2021

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 1Amendments of Therapeutic Goods Regulations

  

Therapeutic Goods Regulations 1990

1  After regulation 15

Insert:

15AA  Clinical trial registries

                   For the purposes of subparagraph 26AF(2)(b)(ii) of the Act, the following registries are prescribed:

                     (a)  a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;

                     (b)  the database known as ClinicalTrials.gov, as the database exists from time to time.

2  After regulation 16GI

Insert:

16GIA  Period for paying evaluation fee for application under subsection 26BD(1) of the Act

                   For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.

3  Regulation 43AAGG

Omit “For section 44A”, substitute “For the purposes of paragraph 63(3)(b)”.

Schedule 2Amendments of Therapeutic Goods (Medical Devices) Regulations

  

Therapeutic Goods (Medical Devices) Regulations 2002

1  Subregulation 11.51(3)

Repeal the subregulation, substitute:

             (3)  Item 2.14 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, applies in relation to a patient‑matched medical device if it is manufactured on or after 25 February 2021 and before 1 November 2024.

2  Part 2 of Schedule 4 (table item 2.14)

Omit “each kind of medical device covered by the description mentioned in paragraph 11.51(3)(b)”, substitute “each kind of patient-matched medical device”.