The Canada – United Kingdom Trade Continuity Agreement (CUK TCA) was entered into force on the 1st of April 2021. The Protocol allows Canada and the United Kingdom to maintain efficient and effective compliance with Good Manufacturing Practices certification for pharmaceutical facilities located in their respective territories by means of mutual recognition.
On the 1st of September 2022 an agreement was made between the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, and the Veterinary Medicines Directorate (VMD) to allow for the prevailing recognition approach to Good Manufacturing Practices inspection results to be expanded to include extra-jurisdictional inspections for human and veterinary finished products included in the scope of Good Manufacturing Practices (GMP) for pharmaceutical products. This will aid in reducing the regulatory burden of importers to obtain information required to demonstrate GMP compliance for their foreign buildings.
The United Kingdoms GMP requirements must however continue to be met, as well as the requirements set out in the Food and Drug Regulations (FDR). Health Canada’s GMP requirements GUI-0001 continue to be applicable, including C.02.019 of the FDR requirements for finished product testing. No GMP exemptions are thus applicable for imported finished dosage form products from these foreign buildings.
The United Kingdoms GMP requirements detail the minimum standard to be met by a medicines manufacturer in their production processes. Products must be :
- Of consistent high quality
- Appropriate to their intended use
- Meet the Marketing Authorisation (MA) requirements/ product specification
Good distribution practice (GDP) requires medicines to be obtained from the licensed supply chain and consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.
The MHRA carries out inspections to assess the compliance of manufacturing and distribution sites with GMP or GDP. If an organisation manufactures or distributes both human and veterinary medicines, MHRA may carry out an inspection of both areas on behalf of the VMD.