The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
The purpose of this guidance is to:
- outline the objectives for introducing a boxed warning to a Product Information (PI) or Consumer Medicine Information document (CMI)
- provide guidance on how and when to use a boxed warning.
The guidance is intended to assist sponsors to understand their obligations and prescribers to understand the rationale for the warning and the magnitude of risk.