Mutual Recognition Agreement between Canada and the European Union (EU)

Date of last update:January 2, 2024

Contact Information: Mutual Recognition Agreement (MRA)

Text of the Agreement

On September 2017, the Comprehensive Economic and Trade Agreement (CETA)- Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products (herein referred to the CETA Protocol for pharmaceuticals) between the European Union and Canada replaced the Canada-EU 1998 Mutual Recognition Agreement (MRA) Annex.

The text of the CETA Protocol for pharmaceuticals can be found at the Global Affairs Canada website.

The CETA Protocol for pharmaceutical is supported by the following administrative arrangements which detail the elements referred to in the protocol. They are also 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

• Key dates
• Scope: Product coverage
• Regulatory authorities involved
• Status summary: Update

Key dates

• September 1998
  • Ratification of the Agreement.
• February 1^st, 2003
  • Start of operational phase for fourteen (14) of the fifteen (15) Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom (UK).
• May 1^st, 2004
  • Accession of Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic, and Slovenia to the European Community.
• June 1^st, 2006
  • Start of operational phase for Hungary and Czech Republic for Human and Veterinary Pharmaceuticals.
• January 1^st, 2007
  • Accession of Bulgaria and Romania to the European Community.
• November 1^st, 2007
  • Start of operational phase for Malta for Human Pharmaceuticals and Cyprus for Human and Veterinary Pharmaceuticals.
• August 1^st, 2009
  • Start of operational phase for Slovak Republic for Human and Veterinary Pharmaceuticals.
• April 1^st, 2011
  • Start of operational phase for Estonia for Human and Veterinary Pharmaceuticals.
• April 1^st, 2012
  • Start of the operational phase for Poland for Human and Veterinary Pharmaceuticals.
• June 1^st, 2013
  • Start of operational phase for Slovenia for Human and Veterinary Pharmaceuticals.
• August 1^st, 2013
  • Start of operational phase for United Kingdom for Veterinary Pharmaceuticals.
• April 1^st, 2016
  • Start of operational phase for Croatia for Human Pharmaceuticals.
• September 2017
  • The Comprehensive Economic and Trade Agreement (CETA) - Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products replaced the Canada-EU 1998 Mutual Recognition Agreement (MRA) Annex.
• December 1^st, 2017
  • Start of operational phase for Lithuania for Human Pharmaceuticals.
• March 1^st, 2018
  • Start of operational phase for Romania for Human Pharmaceuticals.
• September 2019
  • Publication of the Administrative Arrangements supporting the CETA Protocol on Pharmaceuticals.
• September 1^st, 2020
  • Start of operational phase for Portugal for Veterinary Pharmaceuticals.
• January 31^st, 2020
  • The United Kingdom left the European Union and entered a transitional period until December 31, 2020
• January 1^st, 2021
  • Canada-United Kingdom Trade Continuity agreement
• April 1^st, 2021
  • Recognition of Good Manufacturing Practices extra-jurisdictional inspection outcomes
• October 1^st, 2023
  • Start of operational phase for Bulgaria for Human Pharmaceuticals.
• January 1^st, 2024
  • Start of operational phase for Bulgaria for Veterinary Pharmaceuticals

Operational Phase

Once a Regulatory Authority's GMP Compliance Programme is found equivalent based on the CETA Protocol for pharmaceuticals 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 any EU Member State that fall within the scope of the CETA Protocol for pharmaceuticals 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 agreement and that are fully manufactured within one or several EU Member States in which the CETA Protocol for pharmaceuticals is operational, may benefit from specified GMP exemptions as listed in the Canadian Good Manufacturing Practices guide for drug products ( GUI-0001).

Canadian companies importing drugs/medicinal products from an EU Member State in which the CETA Protocol for pharmaceuticals is not operational, cannot benefit from specified GMP exemptions. The same rationale applies when one or several steps of manufacturing of drugs/medicinal products take place in one or more EU Member States in which the CETA Protocol for pharmaceuticals is not operational.

Scope: Product coverage

Human and veterinary medicinal / drug products.

The list of products included in the operational scope of the CETA Protocol for pharmaceuticals, 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

Clarifications:

• 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 (Art. 8).
• 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 Protocol, 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.

  In the European legislation, Directives 2001/83/EC and 2001/82/EC provide definitions of medicinal products including herbal medicinal products. As such, manufactures of these products require a manufacturing authorisation and need to comply with EU GMP.

  Health Canada considers good manufacturing practice requirements of the EU, as being equivalent to the GMP requirements outlined in the Natural Health Products Regulations. Therefore, Health Canada accepts valid Certificate of GMP Compliance issued by the Regulatory Authority within the CETA Protocol for pharmaceuticals, 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 under the Protocol, Health Canada will issue a Certificate of GMP Compliance (GMP certificate) for facilities manufacturing, packaging/labelling, importing, distributing and/or testing NHPs in addition to drugs, which will clearly indicate, which NHPs are held to a drug GMP standard (including premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control department, packaging material testing, finished product testing, records, samples and stability).

  Should a facility manufacture, package/label, import, distribute and/or test NHPs only, Health Canada will perform a full inspection (of the sections stated above) 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 Protocol. A Canadian drug establishment license will not be issued in these cases, as it is not required by Canadian Law.

Temporary exclusions:

• stable medicinal products derived from human blood or human plasma;
• active pharmaceutical ingredients;
• veterinary biologicals; and
• advanced therapy medicinal products.

Definite exclusions:

• blood and blood components.

Regulatory authorities involved

You will find hereafter the list of the EU Regulatory Authorities (RAs) found equivalent and in the operational phase. As explained under "Key Dates", new Member States are joining the EU since 2004. An evaluation of the GMP compliance programme administered by each Regulatory Authority within the new EU Member States is conducted to determine their equivalency with that of the Regulatory Operations and Enforcement Branch GMP Compliance Programme. We will add them to the list progressively as they are found equivalent. Please note that the RAs are identified in their official language(s). If the official language is not English or French, and an English or French denomination is known or used at the international level, it is provided in between quotation marks.

List of Regulatory Authorities by Member State

• Austria
• Belgium
• Bulgaria
• Croatia
• Cyprus
• Czech Republic
• Denmark
• Estonia
• Finland
• France
• Germany
• Greece
• Hungary
• Ireland
• Italy
• Lithuania
• Malta
• Netherlands
• Poland
• Portugal
• Romania
• Slovak_Republic
• Slovenia
• Spain
• Sweden

Status summary: Update

Recognition of Good Manufacturing Practices Extra-Jurisdictional Inspection outcomes (as of April 1, 2021)

Background

On September 21, 2017, the Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA) entered into force provisionally. The CETA outlines the requirements for the establishment of the Regulatory Cooperation Forum (RCF). The forum was implemented to facilitate and promote regulatory cooperation between Canada and the EU.

One initiative under the RCF consists of expanding the existing approach of recognizing Good manufacturing practices (GMP) inspection results to include inspections that are conducted in countries outside of the respective Parties' jurisdictions (i.e. extra-jurisdictional inspections) for products included in the operational scope of the Annex 1 of the CETA Protocol for pharmaceuticals.

As of April 1, 2021, Canada and the EU officially recognized pharmaceutical GMP inspections conducted in countries outside their respective jurisdictions and implemented the exchange of Certificates of GMP Compliance.

Benefits

Stakeholders will benefit from the exchange of Certificates of GMP Compliance between Canada and the equivalent EU regulatory authorities under the CETA Protocol for pharmaceuticals 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 described in the regulations must continue to be met. As such, Health Canada's GMP requirements (GUI-0001) continue to be applicable including C.02.019 Finished product testing requirements. Therefore, there are no GMP exemptions for imported products from these foreign buildings.