Mutual Recognition Agreement between Canada and the European Economic Area - European Free Trade Association (EEA EFTA)
Date of last update: February 4, 2021
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-EEA EFTA Mutual Recognition Agreement
Global Affairs Canada
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Key Dates
November 2000
Ratification of the Agreement
January 2001
Start of the confidence building exercise
November 1st, 2002
Start of operational phase
Operational Phase
Once a Regulatory Authority’s GMP Compliance Programme is found equivalent based on the Mutual Recognition Agreement (MRA) evaluation process, the regulatory authority is considered to be 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 regulatory authority and Canada.
Canadian companies exporting drugs/medicinal products to any EEA-EFTA countries 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 an EEA-EFTA country may benefit from specified GMP exemptions provided by the MRA 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 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 for some EEA EFTA States).
Clarifications:
- Products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation / establishment licence);
- 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).
- Vitamins, minerals, herbal remedies and homeopathic medicinal products are known in Canada as natural health products) manufactured by manufacturers holding a manufacturing authorisation or establishment licence, in the case of Canada.
Natural Health Products (NHPs)
Products regulated in Canada as Natural Health Products (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.
The national legislation in each of the EEA-EFTA countries provide a definition of medicinal products which include herbal medicinal products. As such, manufacturers of these products require a manufacturing authorisation and need to comply with pharmaceutical Good Manufacturing Practices (GMP).
Health Canada considers good manufacturing practice requirements of EEA-EFTA, 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 EEA-EFTA - 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.
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.
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
List of Regulatory Authorities (by country):
- Iceland
- Liechtenstein
- Norway
Status Summary - Update
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