Mutual Recognition Agreement between Canada and the European Community (EC)

Date of last update: March 2st, 2018

Contact Information: Mutual Recognition Agreement (MRA) and International Affairs Unit

Text of the Agreement

The text of the Agreement can be found at the Global Affairs Canada website. In the relevant document, refer to the section entitled "Sectoral Annex on Medicinal Products / Drug Good Manufacturing Practices (GMP) Compliance Certification".

Text of the Canada-EC Mutual Recognition Agreement
Global Affairs Canada

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Key Dates

The MRA was ratified in 1998 but the sector for GMPs did not become operational until February 2003, when all regulatory authorities (RAs) within the EU Member States were thoroughly evaluated by the Health Products and Food Branch (HPFB) Inspectorate and found to have equivalent GMP compliance programmes. More precisely, fourteen (14) of the original fifteen (15) Member States were included in the operational phase.

The EC evaluated Canada's GMP compliance programme in 2000 and found us to be equivalent.

With the accession of 10 new EU Member States in May 1, 2004, it was decided that the countries would be evaluated one at a time. Once all regulatory authorities (typically one or two) within a country are considered as equivalent, the country would be considered as equivalent and the operational phase would start.

The same process will be used for the 2 new Member States, which joined the EU on January 1, 2007.

September 1998
Ratification of the Agreement.

February 1st, 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 1st, 2004
Accession of Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic, and Slovenia to the European Community.

June 1st, 2006
Start of operational phase for Hungary and Czech Republic.

January 1st, 2007
Accession of Bulgaria and Romania to the European Community.

November 1st, 2007
Start of operational phase for Malta and Cyprus.

August 1st, 2009
Start of operational phase for Slovak Republic.

April 1st, 2011
Start of operational phase for Estonia.

April 1st, 2012
Start of the operational phase for Poland.

June 1st, 2013
Start of operational phase for Slovenia

August 1st, 2013
Start of operational phase for United Kingdom-Veterinary

April 1st, 2016

Start of operational phase for Croatia

December 1st, 2017

Start of operational phase for Lithuania

March 1, 2018
Start of operational phase for Romania

Based on the Mutual Recognition Agreement (MRA) evaluation process, the Good Manufacturing Practices Compliance Programme of the Romanian regulatory authority for human drugs was found equivalent to the one in Canada.

Since March 1, 2018, the regulatory authority is considered in the Operational Phase of the MRA, meaning that the exchange of Certificates of Compliance and the information on the Two-Way Alert System is shared between the Romanian human and Canadian regulatory authorities.

Canadian companies exporting drugs/medicinal products to any EC Member States that fall within the scope of the MRA and that are manufactured within Canada may benefit from specified GMP exemptions provided by the MRA.

Canadian companies importing drugs/medicinal products that fall within the scope of the MRA and that are fully manufactured within one or several EC Member States in which the MRA is operational, may benefit from specified GMP exemptions provided by the MRA as listed in the Canadian GMP guideline.

Canadian companies importing drugs/medicinal products from an EC Member State in which the MRA is not operational, may not benefit from specified GMP exemptions provided by the MRA. The same rationale applies when one or several steps of manufacturing of drugs/medicinal products take place in one or more EC Member States in which the MRA is not operational.

Scope - Product Coverage

Human and veterinary medicinal / drug products.

The list of products covered, as written in the Agreement, is given below:

  • human pharmaceuticals including prescription and non-prescription drugs, and medicinal gases;
  • human biologicals including vaccines, stable medicinal products derived from human blood or human plasma, biotherapeutics, and immunologicals;
  • human radiopharmaceuticals;
  • veterinary pharmaceuticals, including prescription and non-prescription drugs, and pre-mixes for the preparation of veterinary medicated feeds;
  • where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products; and
  • active pharmaceutical ingredients or bulk pharmaceuticals (Note: APIs are not GMP regulated).

Clarifications:

  • manufactured drugs used in clinical trials (Note: currently limited to sites already holding a manufacturing authorisation / establishment licence);
  • natural health products (NHP) (Note: currently, certificates of compliance are provided by MRA partners.  In Canada, regulatory amendments are being prepared that will allow Canadian NHP companies to hold an establishment licence in addition to the site licence required under the Natural Health Products Regulations);
  • pre-authorization / pre-marketing GMP inspections (Note: as of October 1st 2004, the Pre-Authorization / Pre-Marketing GMP Inspections are included under the scope of the MRA); and
  • human biologicals (Note: 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).

Temporary exclusions:

  • stable medicinal products derived from human blood or human plasma; and
  • active pharmaceutical ingredients or bulk pharmaceuticals.

Definite exclusions:

  • blood and blood components; and
  • veterinary biologics.

Regulatory Authorities Involved

Fourteen (14) of the fifteen (15) original Member States of the EC are involved. Luxemburg is not included in the operational phase as it does not have a GMP inspection programme. As explained under "Key Dates", ten (10) new Member States have joined on May 1st 2004 as well as two (2) others on January 1st, 2007. We are currently conducting evaluations of the GMP compliance programmes administered by each Regulatory Authority within the New EC Member States to determine their equivalency with that of the Regulatory Operations and Regions Branch. We have to evaluate and find equivalent their respective Regulatory Authority before they can be included in the following list. We will add them to the list progressively as they are found equivalent.

You will find hereafter the list of the EC Regulatory Authorities (RAs) found equivalent as well as the scope of the products covered by the MRA. 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 "italic".

List of Regulatory Authorities by Member State:

Status Summary - Update

EC-Canada Mutual Recognition Agreement
Sectoral Annex on Good Manufacturing Practices

Common Statement regarding the Scope of the MRA (as of March 17, 2008)

Background

A new federal Natural Health Products Regulations governing natural health products (NHPs) in Canada came into effect 1 January 2004. As a result of these regulations certain products which were previously regulated as drugs (medicinal products) are now regulated as natural health products (e.g. vitamins, minerals, herbal remedies, homeopathic medicines and probiotics). Due to the new NHP regulations, drug establishment licenses previously held by natural health product companies are considered expired and have not been renewed since January 2006. In order to bring these products back within the scope of the MRA, Health Canada is preparing a regulatory amendment which would allow, on a voluntary basis, Canadian natural health product companies to hold an establishment licence, issued based on compliance with pharmaceutical Good Manufacturing Practices (GMP), in addition to the site licence required under the NHP Regulations. Further information is available on the Natural Health Products website. Health Canada will update EC of any progress in this matter.

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.

Interim Measures for Natural Health Products with respect to the MRA Agreement

Recognising that the Canadian regulations have their own set of GMP requirements for natural health products and do not require these products to be manufactured in a facility to a GMP level equal to those for drugs, many companies do ensure this level of manufacture.

With respect to the MRA agreement, products regulated in Canada as NHPs will be captured by this MRA, 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.

Upon request of a Canadian exporter, or a Regulatory Authority under the MRA, Health Canada will issue a Certificate of 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 Compliance in support of the activities, listing all of the products to be exported to an MRA country. A Canadian drug establishment license will not be issued in these cases, as it is not required by Canadian Law.

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 GMP certificates issued by the Regulatory Authority within the EC - Canada MRA, 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.

Health Canada is continuing to pursue its regulatory amendment which would allow Canadian NHP companies to hold an establishment license based on drug GMP compliance. Until such time as this legislative amendment is passed, the approach noted above will facilitate trade under the MRA.

Further information on the MRA Sectoral Annex can be found on the European Medicines Agency (EMA) website and the Global Affairs Canada website.

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