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 Note: This table relates only to the provisions of this instrument as originally made.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