Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices
Published 1 September 2022
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1. Background
On April 1, 2021, the Canada - United Kingdom Trade Continuity Agreement (CUK TCA) entered into force. The CUK TCA Protocol on the mutual recognition of the compliance and enforcement programme regarding Good Manufacturing Practices (GMP) for pharmaceutical products (herein referred to as the Protocol for pharmaceuticals) allows Canada and the United Kingdom to maintain its efficiency and effectiveness of compliance and enforcement efforts, through a mutual recognition of certification for GMP for pharmaceutical facilities located in their respective territories.
As of September 1, 2022, Health Canada, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) agreed to expand the existing approach of recognizing GMP inspection results to include inspections that are conducted in countries outside of the respective Parties’ jurisdictions (i.e. extra-jurisdictional inspections) for human and veterinary finished products included in the operational scope of the Annex 1 of the Protocol for pharmaceuticals.
2. Benefits
Stakeholders will benefit from the exchange of Certificates of GMP Compliance between Canada and the United Kingdom for inspections conducted outside of their respective jurisdictions. This will contribute to reducing the regulatory burden for the importers to obtain information to demonstrate compliance to GMP for their foreign buildings.
3. No GMP exemptions
The UK’s GMP requirements must continue to be met, as must those set out in the Food and Drug Regulations (FDR). As such, Health Canada’s GMP requirements (GUI-0001) continue to be applicable, including C.02.019 of the FDR for finished product testing requirements. Therefore, there are no GMP exemptions for imported finished dosage form products from these foreign buildings.