The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
This guidance is for sponsors of all medicines that contain, or are manufactured using materials of animal or human origin.
It provides guidance on the information required in applications to:
- register or list a medicine on the Australian Register of Therapeutic Goods (ARTG) to demonstrate their safety with regard to adventitious agents
- vary the details of a registered prescription medicine.
This guidance does not address safety issues for sterility, or for endotoxin, chemical or other types of contamination.