Therapeutic Goods (Restricted Medicines) Specification 2021 (Cth)

Therapeutic Goods (Restricted Medicines) Specification 2021

I, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following specification.

Dated 23 September 2021

Dr Jane Cook

First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health

Contents

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

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

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

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

5  Restricted medicines................................................................................................................. 1

6  Repeals..................................................................................................................................... 2

Schedule 1—Restricted medicines  3

Schedule 2—Repeals  4

Restricted Medicine Specification 2011   4

1  Name

This instrument is the Therapeutic Goods (Restricted Medicines) Specification 2021.

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	30 September 2021.	30 September 2021

Note:          This table relates only to the provisions of this instrument as originally made.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 subsections 3(2A) and 3(2B) 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)    current Poisons Standard;

(b)    medicine;

(c)    restricted medicine.

In this instrument:

Act means the Therapeutic Goods Act 1989.

Regulations means the Therapeutic Goods Regulations 1990.

5  Restricted medicines

(1) For subsection 3(2A) of the Act, a medicine mentioned in an item in the table in Schedule 1 is specified for the purposes of paragraph (a) of the definition of restricted medicine in subsection 3(1) of the Act.

(2) For subsection 3(2B) of the Act, a medicine included in a class of medicine mentioned in an item in the table in Schedule 1 is specified for the purposes of paragraph (b) of the definition of restricted medicine in subsection 3(1) of the Act.

6  Repeals

Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

Schedule 1—Restricted medicines

Note:       See section 5.

Restricted medicines

Column 1

Column 2

Item

Medicine or class of medicine

1

a medicine that is a product of a kind mentioned in an item in the table in Part 1 of Schedule 10 to the Regulations, other than a product mentioned in:

(a)  paragraph (b) in column 2 of item 1; or

(b)  item 14

2

a medicine that contains a substance in Schedule 3 to the current Poisons Standard

Schedule 2—Repeals

Note:       See section 6.

Restricted Medicine Specification 2011

1  The whole of the instrument

Repeal the instrument.