Therapeutic Goods (Things that are Biologicals) Specification 2019

I, Jane Cook, as delegate of the Secretary of the Department of Health, make the following specification.

Dated 13 December 2019

Dr Jane Cook

First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Things that are biologicals

6  Repeals

Schedule 1—Things that are biologicals

Schedule 2—Repeals

Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1)

1  Name

  This instrument is the Therapeutic Goods (Things that are Biologicals) Specification 2019.

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Note: This table relates only to the provisions of this instrument as originally made.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 subsection 32A(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)      biological.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

faecal microbiota transplant product has the same meaning as in the Therapeutic Goods Regulations 1990.

5  Things that are biologicals

 The things mentioned in Schedule 1 are specified to be biologicals for the purposes of subparagraph 32A(1)(a)(ii) of the Act.

Note: The meaning of biological in section 32A of the Act includes a thing that is specified under subsection 32A(1)(a)(ii).

6  Repeals

  Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

Schedule 1—Things that are biologicals

Note: See section 5.

Schedule 2—Repeals

Note: See section 6.

Therapeutic Goods (Things that are Biologicals) Specification 2017 (No.1)

1  The whole of the instrument

Repeal the instrument