Guidance

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).

How to confirm that your OTC application is an N1 application and how to compile the information and assurances for N1 applications.

Guidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

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

Guidance to help sponsors determine if their therapeutic goods are medicines, biologicals, or medical devices.

Guidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.

Guidance on complying with the Essential Principles for medical devices in Australia, including safety and performance requirements, risk management, design, and evidence needed for ARTG inclusion.

Guidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.

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

This guidance outlines pharmacists’ regulatory responsibilities when supplying therapeutic vapes to support patients in quitting smoking or managing nicotine dependence.

Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.

This guidance is for sponsors of applications for inclusion of medical devices, including in vitro diagnostic (IVD) devices, in the Australian Register of Therapeutic Goods (ARTG).

This guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.

Guidance for manufacturers to help you manage risks and meet regulatory requirements.

This guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.

Guidance to help sponsors comply with changes to the Permissible Ingredients Determination.

Guidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.

Guidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.

Learn how to change the sponsor of a therapeutic good in Australia, including requirements, process steps, and regulatory obligations for sponsors and manufacturers.

Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.

Guidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.

Guidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).

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.