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GMP clearance for overseas manufacturers

17th edition

16 May 2011

Good Manufacturing Practice (GMP) clearance is required for all medicines (unless exempt) supplied in Australia. The TGA has produced guidance for sponsors who rely on overseas manufacturers for any part of their production process.

The guidance has two main purposes:

  • to provide adequate information about what is an acceptable form of evidence to confirm GMP compliance by overseas manufacturers
  • to offer practical guidance on how to submit such evidence to the TGA for assessment.

The guidance does not provide a definitive list of acceptable or unacceptable forms of evidence.

Guidance on the GMP clearance of overseas medicine manufacturers

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Content last updated: Monday, 16 May 2011

Content last reviewed: Monday, 29 April 2013

Web page last updated: Wednesday, 1 May 2013