Medicines

General information about medicines, as well as advice on safety information, medicines and pregnancy, and medicine shortages.

Medicines pages

How we regulate medicines

20 June 2019

Reference material

Learn how your medicines are regulated in Australia.
Find information about a medicine

Page

Search for medicines allowed to be supplied in Australia, medicine ingredients and safety information.
How we regulate

Section

Find out how to get a medicine or medical device into the ARTG so you can legally sell it in Australia.

More information

Dispose of unwanted medicines

Safe disposal of unwanted medicines

Health professionals

University student education materials

Medicines

Latest alerts

Update: Ozempic supply to remain limited in 2025

17 December 2024

Medicine shortage alerts

The supply of Ozempic (semaglutide) will continue to be limited until 31 December 2025
Discontinuation of Protaphane InnoLet insulin cartridges and approval of a substitute

16 December 2024

Medicine shortage alerts

Pharmacists can use a Serious Scarcity Substitution Instrument (SSSI) to dispense Protaphane Penfill human insulin in the place of a Protaphane InnoLet cartridge.
Shortage of methylphenidate hydrochloride modified-release tablets

28 November 2024

Medicine shortage alerts

Due to the concerns and difficulties caused by such shortages, we are giving patients and prescribers early notification so that they can plan ahead.

Latest articles

Recall reforms update and new procedure

20 December 2024

News

Recall reforms program update and preview of the PRAC Version 1.0.
Product Information safety updates - December 2024

16 December 2024

Safety updates

Information for health professionals about medicines with safety related updates to their Product Information.
Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances

9 December 2024

Notices

MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.

Latest publications

ACCM meeting statement, Meeting 34, 14 March 2024

18 December 2024

Meeting statements

Advisory Committee on Complementary Medicines meeting statement for 14 March 2024
Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #45, ACCS #39, Joint ACMS-ACCS #37

16 December 2024

Scheduling decisions (final)

This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
ACM meeting statement, Meeting 47, 3 and 4 October 2024

21 November 2024

Meeting statements

Advisory Committee on Medicines meeting statement

Latest consultations

Consultation: Adoption of International Scientific Guidelines in Australia R01-2024

16 January 2025

Consultation

We are seeking feedback on whether 19 international scientific guidelines should be adopted.
Consultation: Medicine shortages and discontinuations - Reportable medicines and timeframes for reporting discontinuations

13 January 2025

Consultation

We are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia.
Consultation: Proposed amendments to the Poisons Standard – ACMS and Joint ACMS-ACCS meetings, November 2024

22 October 2024

Consultation

Have your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS), meeting of the Advisory Committee on Chemicals Scheduling (ACCS), or a joint meeting of these two committees.

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How we regulate medicines

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How we regulate

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Dispose of unwanted medicines

Health professionals

University student education materials

Latest alerts

Update: Ozempic supply to remain limited in 2025

Discontinuation of Protaphane InnoLet insulin cartridges and approval of a substitute

Shortage of methylphenidate hydrochloride modified-release tablets

Latest articles

Recall reforms update and new procedure

Product Information safety updates - December 2024

Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances

Latest publications

ACCM meeting statement, Meeting 34, 14 March 2024

Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #45, ACCS #39, Joint ACMS-ACCS #37

ACM meeting statement, Meeting 47, 3 and 4 October 2024

Latest consultations

Consultation: Adoption of International Scientific Guidelines in Australia R01-2024

Consultation: Medicine shortages and discontinuations - Reportable medicines and timeframes for reporting discontinuations

Consultation: Proposed amendments to the Poisons Standard – ACMS and Joint ACMS-ACCS meetings, November 2024

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