When master file may be approved
3 When master file may be approved
The Secretary may approve a technical master file or an update of such a file only if the Secretary is satisfied that the technical master file demonstrates that manufacture of the blood or blood components conforms with each standard that is applicable to the blood or blood components (as in force at the time the Secretary is so satisfied).
The Secretary may approve a plasma master file or an update of such a file only if the Secretary is satisfied that the plasma master file demonstrates that manufacture of the plasma conforms with each standard that is applicable to the plasma (as in force at the time the Secretary is so satisfied).
Guidance on the preparation of plasma master files can be found in the Guideline on the Scientific Data Requirements for a Plasma Master File (PMF) published by the European Medicines Agency. The current revision of the Guideline could in 2026 be viewed on the Therapeutic Goods Administration website (www.tga.gov.au).
This Act’s bill:Explanatory statement
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