Prescription medicines collection

Guidance on applying for a provisional determination, which is the first step of the provisional approval pathway.

Guidance on how to request early scientific advice on a biowaiver justification.

Guidance on how we make use of assessments from comparable overseas regulators (CORs).

Guidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

Guidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.

Guidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.

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 reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.