Mutual Recognition Agreement between Canada and the United Kingdom

Date of last update: May 31st, 2021
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 for pharmaceuticals 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 :

On this page:

Key Dates

January 31, 2020
United Kingdom (UK) left the European Union (EU) and entered a transitional period until December 31, 2020

January 1st, 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 1st, 2021
Canada – United Kingdom Trade Continuity Agreement entered into force

Operational Phase

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:

Clarifications:

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.

Temporary exclusions:

Definite exclusions:

Regulatory Authorities Involved

List of United Kingdom Regulatory Authorities

Status Summary – Update

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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