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

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

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