Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Exempt Monographs) Amendment Determination 2022

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

Dated 25 March 2022

Nick Henderson

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

 

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments

Therapeutic Goods (Exempt Monographs) Determination 2021

Schedule 2—Repeals

Therapeutic Goods (Exempting monographs of pharmacopoeias) Determination No. 1 of 2011

 

1  Name

  This instrument is the Therapeutic Goods (Exempt Monographs) Amendment 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

31 March 2022.

31 March 2022

Note: This table relates only to the provisions of this instrument as originally made.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 section 3C of the Therapeutic Goods Act 1989.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

Therapeutic Goods (Exempt Monographs) Determination 2021

1  Schedule 1 (at the end of the table)

Add:

2

antithrombin III human

United States Pharmacopeia-National Formulary

therapeutic goods

3

factor IX complex

United States Pharmacopeia-National Formulary

therapeutic goods

4

pancreatin

United States Pharmacopeia-National Formulary

therapeutic goods

5

pancrelipase

United States Pharmacopeia-National Formulary

therapeutic goods

6

plasma protein fraction

United States Pharmacopeia-National Formulary

therapeutic goods


Schedule 2—Repeals

Therapeutic Goods (Exempting monographs of pharmacopoeias) Determination No. 1 of 2011

1  The whole of the instrument

Repeal the instrument.