Therapeutic Goods (Mercury - Form for Application to Import or Export) Approval 2023

I, John Jamieson, as delegate of the Secretary of the Department of Health and Aged Care, make the following approval.

Dated 7 September 2023

John Jamieson
Assistant Secretary
Medical Devices and Product Quality Division
Health Products Regulation Group
Department of Health and Aged Care

1. Name

This instrument is the Therapeutic Goods (Mercury—Form for Application to Import or Export) Approval 2023.

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Note: This table relates only to the provisions of this instrument as originally made.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 subregulation 10JD(4) of the Therapeutic Goods Regulations 1990.

4. Definitions

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

1. Secretary;
2. therapeutic goods.

Note 2: A number of expressions used in this instrument are defined in regulation 2 of the Regulations, including the following:

1. mercury;
2. Minamata Convention;
3. Therapeutic Goods Administration.

In this instrument:

Act means Therapeutic Goods Act 1989.

Regulations means the Therapeutic Goods Regulations 1990.

5. Approved form

For the purposes of paragraph 10JD(2)(a) of the Regulations, the approved form for an application to the Secretary, under subregulation 10JD(1) of the Regulations, for approval to:

1. import into Australia a therapeutic good that is mercury from a non-party to the Minamata Convention; or
2. export from Australia a therapeutic good that is mercury;

is the application form titled Application to import or export a therapeutic good that is mercury published on the Therapeutic Goods Administration website.