Prescription medicines collection

Guidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

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

Guidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.

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

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.