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Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances

9 August 2013

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11.3 Sponsor's obligations regarding Drug Master Files


  • have an obligation under the standard conditions of registration, imposed under s. 28(3) of the Therapeutic Goods Act 1989 (the Act), to ensure no changes are made to the product, including the drug substance, without their knowledge and TGA approval (if required).
  • need a formal agreement with the manufacturer of the drug substance that ensures they will be notified before any changes are made to the drug substance.
  • are responsible for determining whether:
    • the proposed changes require data to be submitted to the TGA
    • the variation can be made as a self-assessable request.

11.3.1 Updating drug master files

DMFs should be updated periodically to reflect any changes, and ensure that one of the following is forwarded to the TGA before the changes are implemented:

  • the updated DMF (together with a detailed list of changes made), or
  • details of any changes made.

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