Guidance

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

Guidance on requirements relating to impurities in prescription medicines entered 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 on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.

Guidance to assist sponsors to understand the process for submitting a priority registration application.

Guidance on when and how to provide Product Information to us.

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

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

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.

Guidance on the evaluation process and information required for new registered complementary medicines.

Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.

Guidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).

Guidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.

Guidance on provisional registration process for prescription medicines with provisional determination.

This guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.

Guidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.

Australian recommendations and requirements

Guidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.

Guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.

Guidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.

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

Classifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.

Guidance on TGO 109: Standards for Biologicals - General and Specific Requirements.

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 using reports from COBs and submission requirements for evaluation of these applications.