The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Purpose
If you are a sponsor of a biological included on the ARTG and you need to release a product that does not meet all of the usual safety or manufacturing standards, then you need to request approval for an exceptional release of a non-conforming biological.
Exceptional release of a non-conforming biological is only permitted under prescribed circumstances and for an individual patient.
Information on this page outlines:
- the prescribed circumstances when exceptional release is permitted
- sponsor's responsibilities before and after supplying a non-conforming biological
- how to access and complete the form for an exceptional release request.