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GMP clearance for overseas manufacturers
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.