Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024 (Cth)

Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024

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

Dated 4 June 2024

Nicholas Henderson

First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health and Aged Care

Contents

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1Name

This instrument is the Therapeutic Goods (Authorised Supply) Amendment (SAS Guidance) Rules 2024.

2

Commencement

1. (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 made.

Note: This table relates only to the provisions of this instrument as originally made.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.

1. (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.

3Authority

This instrument is made under subsections 19(7A), 32CM(7A) and 41HC(6) of the Therapeutic Goods Act 1989.

4Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1AmendmentsTherapeutic Goods (BiologicalsAuthorised Supply) Rules 20221

Section 4 (definition of SAS guidance)

Repeal the definition, substitute:

SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 2.0, March 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 April 2024.

Note: The SAS Guidance is published at level="9">Therapeutic Goods (Medical DevicesAuthorised Supply) Rules 20222

Section 4 (definition of SAS guidance)

Repeal the definition, substitute:

SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 2.0, March 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 April 2024.

Note: The SAS Guidance is published at level="9">Therapeutic Goods (Medicines and OTGAuthorised Supply) Rules 20223

Section 4 (definition of SAS guidance)

Repeal the definition, substitute:

SAS Guidance means the document titled Special Access Scheme (SAS): Guidance for health practitioners accessing unapproved therapeutic goods (Version 2.0, March 2024) published by the Therapeutic Goods Administration, as in force or existing on 1 April 2024.

Note: The SAS Guidance is published at 1 (table item 36)

Repeal the item.