Therapeutic Goods (Medicine Shortages and Discontinuations - Notification Forms) Approval 2023

I, Nicholas Henderson, as delegate of the Secretary of the Department of Health, make the following approval.

Dated 8 November 2023

Nicholas Henderson
First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health and Aged Care

Contents

1 Name

This instrument is the Therapeutic Goods (Medicine Shortages and Discontinuations - Notification Forms) Approval 2023.

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Note: This table relates only to the provisions of this instrument as originally made.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 paragraphs 30EF(4)(a), 30EFA(3)(a) and 30EG(4)(a) of the Therapeutic Goods Act 1989.

4 Definitions

In this instrument:

Act means Therapeutic Goods Act 1989.

TGA Business Services means the TGA Business Services portal, accessed via the Therapeutic Goods Administration website.

Note:  The Therapeutic Goods Administration website can be accessed at www.tga.gov.au.

Therapeutic Goods Administration, or TGA, means the part of the Department known as the Therapeutic Goods Administration.

5 Approved notification form - medicine shortage

For the purposes of notifying the Secretary of a shortage of a reportable medicine in Australia under subsection 30EF(1) of the Act, the approved form is the online form titled New Medicine Shortage Notification accessed via the Notification item under the Medicine Shortages heading within the Create Applications & Submissions section of the sponsor portal within the Medicines Shortages link in the Your TGA tab in TGA Business Services.

6 Approved notification form - medicine shortage change and resolution

For the purposes of notifying the Secretary of a change to the period of a shortage, or resolution of a shortage, of a reportable medicine in Australia under subsections 30EFA(1) and (2) of the Act, the approved form is the online form titled New Medicine Shortage Notification, accessed via the Notification item under the Medicine Shortages heading within the Create Applications & Submissions section of the sponsor portal within the Medicines Shortages link in the Your TGA tab in TGA Business Services.

7 Approved notification form - discontinuation of supply of medicine

For the purposes of notifying the Secretary of a decision to permanently discontinue the supply of a reportable medicine in Australia under subsection 30EG(1) of the Act, the approved form is the online form titled New Medicine Shortage Notification, accessed via the Notification item under the Medicine Shortages heading within the Create Applications & Submissions section of the sponsor portal within the Medicines Shortage link in the Your TGA tab in TGA Business Services.

8 Repeals

Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.

Schedule 1 - Repeals

Note: See section 8.

Therapeutic Goods (Medicine Shortages and Discontinuations—Notification Forms) Approval 2021

1 The whole of the instrument

Repeal the instrument.