Only Australian manufacturing sites can obtain a manufacturing licence.
Overseas manufacturers can instead obtain Good Manufacturing Practice (GMP) clearance or certification. For details see the below information:
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PageThis information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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User guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.
More information
- International agreements and arrangements for GMP clearance
- GMP surveillance inspections and extended validity of TGA GMP certificates
- GMP Clearance applications using Health Canada evidence
- Australian manufacturing licences and overseas GMP certification: a step by step guide
- Declaration of intent to supply the Australian market
- Access Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition
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