Guidance

Guidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

This guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.

Guidance on our approved terminology for medicines.

Guidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).

Guidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.

Guidance on the information that we include in AusPARS for prescription medicines and when we publish them.

This guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.

Information for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them.

Guidance to explain how the intended use of a biological product influences its classification and exemptions.

Guidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

Guidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.

This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.

This guidance helps providers of digital mental health services or products to understand their regulatory obligations.

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

Guidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.

Guidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.

Guidance on advertising services that involve therapeutic goods.

This guidance aims to help advertisers apply the legislative requirements for advertising therapeutic goods on social media platforms.

Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.

Guidance on how the Poisons Standard is amended and the processes that underpin scheduling policy