Guidance

This guidance explains the administrative and prescribing (dossier) information you need to support the registration of a prescription medicine. It also applies to varying the details of an Australian Register of Therapeutic Goods (ARTG) registration for a prescription medicine.

Australian recommendations and requirements

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.

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.

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

Guidance on the format requirements for dossiers. Amendments to Part C to update the reference for dossier requirements for biologicals.

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

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

Guidance to change an ARTG registered over-the-counter (OTC) medicine.

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

This guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.

Requirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).

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

Guidance for manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)

This guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.

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

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

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 for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for supplying substitute medicines when registered medicines are unavailable or in short supply.

Guidance to help manufacturers of medical devices classify their devices correctly.

An overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.

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

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.