Prescription medicines collection

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 on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma

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

Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.

Guidance on the process and regulatory requirements to register prescription medicines.

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.

Guidance on how the Poisons Standard is amended and the processes that underpin scheduling policy

Risk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.