Mutual Recognition Agreement between Canada and the European Economic Area - European Free Trade Association (EEA EFTA)

Date of last update: June 10, 2011

Contact Information: Quality and International Assessment Division

Text of the Agreement

The text of the Agreement can be found at the Canadian Department of Foreign Affairs and International Trade (DFAIT) 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
 Canadian Department of Foreign Affairs and International Trade (DFAIT)

On this page:

• Key dates
• Scope - Product Coverage
• Regulatory Authorities Involved
• Status summary - Update

Key Dates

November 2000
Ratification of the Agreement

January 2001
Start of the confidence building exercise

November 1^st, 2002
Start of operational phase

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 GMP Guideline.

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 and not yet by Canada).

Clarifications:

• manufactured drugs used in clinical trials (Note: currently limited to sites already holding a manufacturing authorisation / establishment licence);
• natural health products (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 NHP Regulations); 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

List of Regulatory Authorities (by country):

• Iceland
• Liechtenstein
• Norway

Status Summary - Update

EEA-EFTA-Canada Mutual Recognition Agreement
Sectoral Annex on Good Manufacturing Practices

Common Statement regarding the Scope of the MRA (as of December 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 EEA-EFTA of any progress in this matter.

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).

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 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.

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 Economic Area and the European Free Trade Association (EEA-EFTA) website and the  Canadian Department of Foreign Affairs and International Trade (DFAIT) website.

Common Statement regarding the Scope of the MRA (Manufactured Drugs used in Clinical Trials)

Further to some discussion between EEA-EFTA and Canada as of December 17^th, 2008, it was agreed that manufactured drugs used in clinical trials will be included under the scope of the MRA agreement. The Common Statement is as follows:

• manufactured drugs used in clinical trials (Note: currently limited to sites already holding a manufacturing authorisation / establishment licence)