Overseas manufacturers

Sponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.

Last updated

8 December 2022

Only Australian manufacturing sites can obtain a manufacturing licence.

Overseas manufacturers can instead obtain Good Manufacturing Practice (GMP) clearance or certification.

For details go to Sponsor responsibilities related to GMP clearance and certification.

More information

GMP clearance guidance
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

COVID-19

GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic

Topics

Manufacturing

This webpage on the TGA website was printed on 14 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp/overseas-manufacturers

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Overseas manufacturers

More information

COVID-19

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