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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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5: Making a statutory declaration

  • For new manufacturing licences, provide us with a statutory declaration on Certificate 38(1)(g). This declaration relates to specific convictions and financial penalties in the 10 years prior to your application. For details, see section 38(1)(g) and 38(1)(h) of the Therapeutic Goods Act 1989. Include the manufacturing licence application tracking number on the declaration form
  • If you are unable to certify that the persons mentioned in the certificate meet the criteria, you can ask us to consider any special circumstances before we make a decision

Submit the declaration with your licence application or email it to the Manufacturing Quality Branch with reference to your application tracking number.

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