Updated GMP clearance information

Health Canada agreement on GMP inspections

Following the agreement signed with Health Canada in 2024 for extra-jurisdictional inspections, the How to obtain GMP clearance through inspection reliance has been updated to include information about this pathway. 

Additionally the GMP clearance application and submission user guide has been updated to include specific instructions to navigate the application e-form when submitting this application type.

Adoption of Annex 16 of the PIC/S Guide to GMP

Following the adoption of Annex 16 “Authorised Person and Batch Release” in June 2024 and the end of the transition period in September 2024, the How to obtain GMP clearance through inspection reliance resource has been updated to include information on evidence that may be requested during the GMP Clearance evaluation to address the requirements of the annex. 

There is no change to the upfront evidence requirements at this stage.

Correct use of letters of access

When used correctly, certain Letters of Access (LoA) can be an effective type of evidence to reduce the regulatory burden on industry as well as reduce the effort required by the TGA to evaluate the GMP Clearance.

We continue to observe the incorrect use of LoAs causing delays and confusion for both industry and TGA.

The How to obtain GMP clearance through inspection reliance information resource has been updated to provide greater clarity on the correct use of LoAs.

Further information

If you have any questions in relation to these updates or about the information resources, please contact GMPclearance@health.gov.au before submitting your applications.