GMP clearance: Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathway updates

As our regulatory partners continue to return to onsite inspections, we have reviewed and updated our temporary measures for processing GMP clearances via the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways. This ensures Australian sponsors can maintain the validity of their GMP clearances and supply of goods to Australia.

MRA GMP clearances expiring between 31 December 2023 and 31 December 2024 

Where:

• Your existing GMP clearance expires on 31 December 2023 
  • An extension application is not needed. We will automatically extend your GMP clearance until 31 December 2024 and existing extension applications will be removed from the TGA Business Services portal. 
• Your existing GMP clearance has been assessed using the risk-based approach and expires on a date after 31 December 2023.
  • Please submit an extension application as per the GMP clearance guidance. 
• Current evidence is more than 3 years old and you have not submitted a renewal application that has been assessed using our risk-based approach
  • Please submit a renewal application as per the GMP clearance guidance. The application will be assessed using an updated risk-based approach.
• Current evidence is less than 3 years old
  • Please submit a renewal application as per the GMP clearance guidance. The application will be assessed using the existing routine processes.

CV pathway

Where the last onsite inspection of a manufacturer occurred prior to the Covid-19 pandemic (2020-2023) sponsors may continue to use the GMP clearance questionnaire. 

We may also accept an inspection report issued following a successful remote inspection or distant assessment in addition to or, in certain circumstances, instead of the GMP Clearance questionnaire.

In such circumstances, sponsors should be able to justify in writing why the report removes the need for the GMP clearance questionnaire.

We do not accept inspection reports issued following a remote inspection or distant assessment as the primary evidence for a GMP Clearance i.e. it does not replace an inspection report from a physical on-site inspection.

Sponsors should contact GMPclearance@health.gov.au prior to submitting applications if there are doubts around the suitability of any evidence.