Guidance

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

Provides Guidance on the regulatory requirements for labels and other medicine presentation.

This guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.

Guidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices.

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

Guidance on how to interpret Essential Principle 13B and how it applies to your device.

Guidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.

Guidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.

Guidance about the regulation of sport supplements in Australia for importers and sellers.

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.

Guidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.

Guidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.

Guidance for sponsors of COVID-19 IVDs about their ongoing obligations

Guidance for the requirements applicable to medical devices containing poisons.

Guidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.

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 for sponsors and manufacturers about pathways for exporting a ventilator from Australia.

Guidance for sponsors on how and when to use a boxed warning in PI or a CMI.