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 see the below information:

Sponsor responsibilities related to GMP clearance and certification

Page

This information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.
How to obtain GMP clearance through inspection reliance

Page

Find out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
GMP clearance application and submission user guide

11 December 2023

User guide

This user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
GMP clearance code tables

6 July 2020

User guide

Check out our user guide to assist sponsors when using the code tables for GMP Clearance applications.

More information

Topics