Prescription medicines collection

Guidance on submitting an effective prescription medicines application.

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 obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration.

This guidance explains the administrative and prescribing (dossier) information you need to support the registration or variation of a prescription medicine.

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.