Mutual Recognition Agreement between Canada and the United Kingdom
Date of last update: September 1, 2022
Contact Information: Mutual Recognition Agreement (MRA) Unit
Text of the Agreement
Text of the interim Canada-United Kingdom Trade Continuity Agreement (CUK TCA) can be found at the Global Affairs Canada website.
The provisions of the Canada-European Union (EU) CETA Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products are incorporated by reference to the Canada-United Kingdom Trade Continuity Agreement (CUK TCA).
The CETA Protocol for pharmaceuticals is supported by the following administrative arrangements which also apply to the CUK TCA. They are published on the Global Affairs Canada website under CETA Governance and committees :
- Components of the Information Sharing Process
- Two-way Alert Program
- Procedure for Evaluating New Regulatory Authorities
- Equivalence Maintenance Program
- Components of a GMP Compliance Program
- Contact Points
On this page:
January 31, 2020
United Kingdom (UK) left the European Union (EU) and entered a transitional period until December 31, 2020
January 1, 2021
Health Canada, UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) implemented an interim arrangement for continued cooperation on the application of the CETA Protocol for pharmaceuticals until the Canada – United Kingdom Trade Continuity Agreement (CUK TCA) is ratified
April 1, 2021
Canada – United Kingdom Trade Continuity Agreement entered into force
September 1, 2022
Recognition of Good Manufacturing Practices extra-jurisdictional inspection outcomes for human and veterinary finished products
Once a Regulatory Authority's GMP Compliance Programme is found equivalent based on the CUK TCA evaluation process, the regulatory authority is considered to be in the Operational Phase, meaning that the exchange of Certificates of GMP Compliance and the information on the Two-Way Alert System is shared between the regulatory authority and Canada.
Canadian companies exporting drugs/medicinal products to the United Kingdom that fall within the scope of the CUK TCA and that are manufactured within Canada may benefit from specified GMP exemptions.
Canadian companies importing drugs/medicinal products that fall within the scope of the CUK TCA and that are manufactured within the United Kingdom may benefit from specified GMP exemptions provided by the agreement as listed in the Canadian Good Manufacturing Practices guide for drug products (GUI-0001).
Scope: Product coverage
Human and veterinary medicinal / drug products.
The list of pharmaceutical products included in the CUK TCA refers to the operational scope of the CETA Protocol for pharmaceuticals and is given below:
- human pharmaceuticals including prescription and non-prescription medicinal products or drugs, and medicinal gases;
- human biologicals including immunologicals and biotherapeutics;
- human radiopharmaceuticals;
- veterinary pharmaceuticals, including prescription and non-prescription medicinal products or drugs, and pre-mixes for the preparation of veterinary medicated feeds;
- intermediate products and bulk pharmaceuticals;
- products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation or establishment licence; and
- vitamins, minerals and herbal remedies and homeopathic medicinal products (known in Canada as natural health products) manufactured by manufacturers holding a manufacturing authorisation or establishment licence, in the case of Canada
- Pre-authorization / pre-marketing on-site evaluation: A Party has the right to conduct its own product-specific evaluation in the context of marketing authorization
- Human biologicals: The MRA covers GMP evidence for manufacturing sites of human biologicals; it does not address the Canadian requirements for lot-to-lot release of these products as set out under Section C.04.015 of the Food and Drug Regulations.
- Natural Health Products (NHPs)
Products regulated in Canada as Natural Health Products (NHPs) will be captured by this CUK TCA when they are manufactured to a GMP standard equal to those for pharmaceutical drugs. While not limited to the following, these will primarily include specific commercial products of herbal medicines, probiotics and vitamin/minerals.
The UK Human Medicines Regulations 2012 (SI 2012/1916) provide definitions of medicinal products including herbal medicinal products. As such, manufacturers of these products considered as medicinal products require a manufacturing authorisation and need to comply with UK GMP.
Health Canada considers good manufacturing practice requirements of the UK as being equivalent to the GMP requirements outlined in the Natural Health Products Regulations. Therefore, Health Canada accepts valid Certificates of GMP Compliance issued by the UK as evidence of compliance to NHP GMPs. In addition, all products that are manufactured at these sites are considered to be acceptable and do not require further confirmatory finished product testing in Canada.
Upon request of a Canadian exporter, or a Regulatory Authority, Health Canada will issue a Certificate of GMP Compliance for facilities manufacturing, packaging/labelling, importing, distributing and/or testing NHPs which will clearly indicate, which NHPs are held to a drug GMP standard.
Should a facility manufacture, package/label, import, distribute and/or test NHPs only, Health Canada will perform a full inspection and issue a Certificate of GMP Compliance in support of the activities listing all of the products to be exported to a participant to this agreement. Canadian drug establishment license will not be issued in these cases, as it is not required by Canadian Law.
Products not included in the operational scope:
- stable medicinal products derived from human blood or human plasma;
- active pharmaceutical ingredients;
- veterinary biologicals; and
- advanced therapy medicinal products.
- blood and blood components.
Regulatory Authorities Involved
Status Summary – Update
Recognition of Good Manufacturing Practices extra-jurisdictional inspection outcomes (as of September 1, 2022)
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 good manufacturing practices 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.
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.
No GMP exemptions
The GMP requirements outlined in the Food and Drug Regulations (FDR) must continue to be met. 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.
Canada and the United Kingdom Agreement (as of April 1, 2021)
The United Kingdom (UK) left the European Union (EU) on January 31, 2020 and entered a transitional period until December 31, 2020. During the transition period, the Canada - EU Comprehensive Economic and Trade Agreement (CETA) continued to apply.
As CETA ceased to apply to the United Kingdom on January 1, 2021, Canada and the UK have agreed on an interim Canada – United Kingdom Trade Continuity Agreement (CUK TCA) until a bilateral comprehensive free trade agreement is in place.
The Canada-United Kingdom Trade Continuity Agreement entered into force on April 1, 2021.
For stakeholders, this means that Canada and the UK will continue to recognize Certificates of GMP Compliance issued by each country's regulatory agencies; and will continue to accept batch testing certificates issued by a manufacturer without re-control of that batch at import.
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