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Place of manufacture
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There are different requirements for manufacturers located in Australia or overseas.
If your manufacturing site is in Australia, you may require a manufacturing licence from the TGA.
Overseas manufacturers can obtain GMP certification following a successful on-site inspection by the TGA. GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf. GMP certification is usually only requested if it is not possible to obtain GMP clearance via the Mutual Recognition Agreement (MRA) or Compliance Verification (CV) pathways.
Question
Is the manufacturing site located in Australia or overseas?
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