Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances

GMP Clearances issued via the MRA pathway that are expiring on 31 December 2024 will be automatically extended until 31 December 2025. 

This is due to ongoing delays with MRA partners returning to pre-pandemic inspection frequencies.

Sponsors do not need to submit an extension application and we will begin processing these extensions from 9 December 2024. Any applications for extensions submitted by Sponsors will be removed from the system as they will not be required.

Maintaining your active GMP clearance

We encourage sponsors to continue to monitor inspections conducted for their overseas manufacturing and testing facilities. Where more recent inspection evidence is available, you should submit a renewal application to maintain your GMP clearance. 

Your GMP clearance may not be automatically extended if more recent evidence may be available to support a renewal application. 

Where more recent evidence is not available, sponsors may continue to submit an extension application if their existing GMP clearance has already been assessed using a risk-based approach. 

If you have any questions, please contact GMPclearance@health.gov.au before submitting your application.