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GMP clearance for overseas manufacturers
4. Revocation or reduction in scope of a clearance
The TGA may revoke or reduce the scope of a GMP Clearance where:
- GMP Certification is withdrawn by an MRA partner or other regulatory agency.
- Evidence submitted to the TGA is subsequently found to be incorrect.
- The manufacturer or sponsor declines a scheduled re-inspection/audit.
- The outcome of a TGA on-site audit determines that GMP compliance is unsatisfactory.
The sponsor will be notified of the revocation and the reasons for it by mail. The sponsor will have the opportunity to respond.