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

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

2  Commencement

3  Authority

4  Definitions

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

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

7  Repeals

Schedule 1—Members of the European Community and EFTA

Part 1—Members of the European Community

Part 2—Members of the European Free Trade Association

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

Schedule 3—Repeals

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.

Note: This table relates only to the provisions of this instrument as originally made.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.

5  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

Part 2—Members of the European Free Trade Association

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

Note: See section 6.

Schedule 3—Repeals

Note: See section 7.