Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument amends the Therapeutic Goods (Manufacturing Principles) Determination 2020 to incorporate an updated version of the Guide to Good Manufacturing Practice for Medicinal Products.
Administered by: Health and Aged Care
Registered 30 Mar 2022
Tabling HistoryDate
Tabled HR31-Mar-2022
Tabled Senate26-Jul-2022
Date of repeal 26 Oct 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Manufacturing Principles) Amendment Determination 2022

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

Dated 29 March 2022

Tracey Duffy

First Assistant Secretary

Medical Devices and Product Quality Division

Health Products Regulation Group

Department of Health

 


Contents

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

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

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

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments                                                                                           2

Therapeutic Goods (Manufacturing Principles) Determination 2020                                       2

 

 


1  Name

                   This instrument is the Therapeutic Goods (Manufacturing Principles) 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

1 July 2022.

1 July 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Note:          This table relates only to the provisions of this instrument as originally made.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 36 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 (Manufacturing Principles) Determination 2020

1  Section 4 (definition of PIC/S Guide to GMP)

Repeal the definition (including the note), substitute:

PIC/S Guide to GMP means the document Guide to Good Manufacturing Practice for Medicinal Products (PE 009-15, 1 May 2021) published by PIC/S, as in force or existing at 1 July 2022, and includes the Annexes to that document other than the following:

                     (a)  Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);

                     (b)  Annex 5 (Manufacture of immunological veterinary medical products);

                     (c)  Annex 14 (Manufacture of medicinal products derived from human blood or plasma).