Prescription medicines collection

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

Guidance about the types of notifications and variations for biological medicines.

Guidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.

Guidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.

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