Prescription medicines collection

Information on colourings in medicines for topical and oral use.

The Scheduling Policy Framework (Scheduling Policy) sets out the national policy for applying access restrictions on medicines and chemicals.

Find out about our clinical evaluation streams and the functions each unit provides.

This information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.

A code of practice for those involved in the design, selection and use of tamper-evident packaging.

Information for sponsors on demonstrating stability of medicines under Australian conditions.

We provide transparency of the prescription medicines registration process via the online publication of Australian Public Assessment Reports (AusPARs). Explore questions and answers about AusPARs.

How to submit nonclinical studies in Module 4 of the Common Technical Document (CTD).

Information on special considerations required for medicines for use in special populations.