Guidance

Guidance providing an overview of the legislative framework for listed medicines and assessed listed medicines.

This guidance is to assist sponsors in fulfilling the regulatory obligations necessary to ensure that any representations made about their listed medicine(s) comply with the requirements of the Therapeutic Goods Act 1989.

Guidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods.

This Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.

Guidance about how to advertise therapeutic goods exclusively to health professionals.

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological

Learn how to determine whether your product is a cosmetic or therapeutic good and understand the regulatory and advertising requirements that apply.

Guidance on regulatory requirements for Ahpra-registered dental practitioners making and adapting personalised medical devices for patients.

Guidance and examples to help you understand the regulatory framework for personalised medical devices.

Guidance to help applicants understand what a section 41HD application is, how to submit an application, and what evidence will be needed.

Understand the regulatory requirements for supplying UDI compliant medical devices in Australia

Timeframes for supplying UDI compliant medical devices in Australia

This guidance explains the prohibitions that apply to advertising for prescription medicines.

Guidance explaining the post-market surveillance of listed medicines and how we undertake compliance reviews.

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines

This guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.

Guidance on how to advertise health services that involve therapeutic goods, including how to comply with the Act and avoid prohibited advertising.

Guidance about the Annual Charge Exemption (ACE) scheme waiver process.

Guidance on the legislative framework that applies to manufacturing, advertising and supplying compounded medicines.

Guidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.

Guidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.

This guidance explains how overseas assessments can support our medical device certification and registration processes.

Guidance on when a manufacturing licence is required for bacteriophage therapy products and how a time-limited Goods Manufacturing Practice exemption will apply. Understand your regulatory obligations when producing bacteriophage products in Australia.

Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.

This guidance assists entities who disseminate content about therapeutic goods and vaping goods to determine if their material is considered advertising.