Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 2022 (Cth)

Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 2022

I, Cheryl McRae, as delegate of the Minister for Health and Aged Care, make the following determination.

Dated 13 December 2022

Dr Cheryl McRae Assistant Secretary Complementary and Over the Counter Medicines Branch Health Products Regulation Group Department of Health and Aged Care

Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Conditions of listing Schedule 1—Conditions of listing Part 1—Specified listed medicines Part 2—Specified listed medicines that are sunscreens Part 3—Specified listed medicines that may contain aristolochic acids

1 Name This instrument is the Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 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Note: This table relates only to the provisions of this instrument as originally made.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 subsection 28(2) 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) batch; (b) export only medicine; (c) manufacture; (d) medicine; (e) Register; (f) supply. In this instrument: Act means the Therapeutic Goods Act 1989. Regulations means the Therapeutic Goods Regulations 1990. relevant person, in relation to a medicine, means the person in relation to whom the medicine is listed in the Register. specified listed medicines means medicines that are listed in the Register under section 26A or 26AE of the Act. Note: Specified listed medicines do not include export only medicines, which are listed under section 26 of the Act. Therapeutic Goods Administration, or TGA, means that part of the Department known as the Therapeutic Goods Administration.