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This instrument specifies countries that are declared to be a member of the European Community or the European Free Trade Association or covered by a non-EC/EFTA MRA under sections 3A and 3B of the Therapeutic Goods Act 1989.
Administered by: Health and Aged Care
General Comments: This notifiable instrument repeals declarations published in Gazette No. GN 43 on 29 October 2003, Gazette No. GN 38 on 28 September 2005, Gazette No. S 332 on 21 July 1999 and Gazette No. GN 47 on 26 November 2008.
Registered 29 Sep 2022
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (European Community and non-EC/EFTA MRA) Declaration 2022

I, Jennifer Burnett, as delegate of the Minister for Health and Aged Care, make the following declaration.

Dated 28 September 2022

Jennifer Burnett

Acting First Assistant Secretary
Medical Devices and Product Quality Division
Health Products Regulation Group
Department of Health

 

 

 


Contents

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

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

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

4  Definitions................................................................................................................................ 1

5  Declaration—member of the European Community or European Free Trade Association....... 2

6  Declaration—country covered by non-EC/EFTA MRA.......................................................... 2

7  Repeals..................................................................................................................................... 2

Schedule 1—Members of the European Community and EFTA     3

Part 1—Members of the European Community                                                        3

Part 2—Members of the European Free Trade Association                                    4

Schedule 2—Countries covered by non-EC/EFTA MRA                 5

Schedule 3—Repeals                                                                                                     6

 

 


1  Name

                   This instrument is the Therapeutic Goods (European Community and non‑EC/EFTA MRA) Declaration 2022.

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.  The whole of this instrument

The day after this instrument is registered.

 

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 sections 3A and 3B of the Therapeutic Goods Act 1989.

4  Definitions

Note:          A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)    Australia-UK Mutual Recognition Agreement;

(b)    member of EFTA;

(c)    member of the European Community;

(d)    non-EC/EFTA MRA.

                   In this instrument:

Act means the Therapeutic Goods Act.

Australia-Canada Mutual Recognition Agreement means the Mutual Recognition Agreement on Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification between the Government of Australia and the Government of Canada, as in force or existing at the commencement of this instrument.

Australia-Singapore Mutual Recognition Agreement means the Mutual Recognition Agreement on Conformity Assessment between the Government of Australia and the Government of the Republic of Singapore, as in force or existing at the commencement of this instrument.

Declaration—member of the European Community or European Free Trade Association

             (1)  For paragraph 3A(1)(a) of the Act, a country specified in the table in Part 1 of Schedule 1 is declared to be a member of the European Community.

             (2)  For paragraph 3A(1)(b) of the Act, a country specified in the table in Part 2 of Schedule 1 is declared to be a member of the European Free Trade Association.

6  Declaration—country covered by non-EC/EFTA MRA

                   For subsection 3B(1) of the Act, a country specified in column 2 of an item in the table in Schedule 2, is covered by the non-EC/EFTA MRA specified in column 3 of that item.

7  Repeals

                   Each instrument specified in the table in Schedule 3 is repealed.


 

Schedule 1—Members of the European Community and EFTA

Note:       See section 5.

Part 1—Members of the European Community

Member of the European Community

Column 1

Column 2

Item

Country

1

Austria

2

Belgium

3

Bulgaria

4

Croatia

5

Cyprus

6

Czech Republic

7

Denmark

8

Estonia

9

Finland

10

France

11

Germany

12

Greece

13

Hungary

14

Ireland

15

Italy

16

Latvia

17

Lithuania

18

Luxembourg

19

Malta

20

Netherlands

21

Poland

22

Portugal

23

Romania

24

Slovak Republic

25

Slovenia

26

Spain

27

Sweden


 

Part 2—Members of the European Free Trade Association

Member of EFTA

Column 1

Column 2

Item

Country

1

Iceland

2

Liechtenstein

3

Norway


 

Schedule 2—Countries covered by non-EC/EFTA MRA

Note:       See section 6.

 

Country covered by non-EC/EFTA MRA

Column 1

Column 2

Column 3

Item

Country

non-EC/EFTA MRA

1

Canada

Australia-Canada Mutual Recognition Agreement

2

Singapore

Australia-Singapore Mutual Recognition Agreement

3

United Kingdom

Australia-UK Mutual Recognition Agreement


 

Schedule 3—Repeals

Note:       See section 7.

 

Repeal of instruments

Column 1

Column 2

Column 3

Column 4

Item

Name of instrument

Delegate

Date of making

1

DECLARATION UNDER SECTION 3B - COUNTRY COVERED BY NON‑EC/EFTA MRA

Rita Maclachlan

23 October 2003

2

DECLARATION UNDER SECTION 3B - COUNTRY COVERED BY NON‑EC/EFTA MRA

Rita Maclachlan

20 September 2005

3

SECTION 3A DECLARATION – MEMBER OF EUROPEAN COMMUNITY

Grant Tambling

6 July 1999

4

SECTION 3A DECLARATION – MEMBER OF EUROPEAN COMMUNITY

Michael Lok

17 November 2008