The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals (excluding class 1 biologicals), blood and blood components and haematopoietic progenitor cells have responsibilities in relation to:
- during manufacture
- informing the TGA
- licence-specific responsibilities
- GMP inspections
- post-inspection responsibilities.
For Australian manufacturers with licences, many of these responsibilities are legal requirements in the Therapeutic Goods Act 1989- external site - external site and the Therapeutic Goods Regulations 1990- external site - external site. Section 40 of the Therapeutic Goods Act 1989 and Regulations 19 and 20 contain conditions for licence holders.
For overseas manufacturers the same responsibilities and expectations apply, unless otherwise specified.