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MRAs Updates

Date of last update: August 1^st, 2006

Canada is a participant to Mutual Recognition Agreements (MRAs), covering drug/medicinal products Good Manufacturing Practices (GMP) Compliance Programmes, with the following Parties:

The European Community (EC)
Switzerland
The European Economic Area - European Free Trade Association (EEA EFTA) States: the Republic of Iceland, the Principality of Liechtenstein and the Kingdom of Norway
Australia

The equivalency of the GMP Compliance Programmes is determined according to a three (3) phase confidence building process:

documentation review;
evaluation of processes and procedures including on-site evaluations; and
decision making on the results of the evaluation.

The results of the evaluation are based on objective assessment criteria and documented evidence and are used to determine equivalency. The evaluation results remain valid as long as the agreement between the two parties is in effect and where no significant changes to the GMP Compliance Programmes have been introduced.

The following provides an update for each of the MRAs that the Health Products and Food Branch Inspectorate is responsible for.

MRA between Canada and the European Community (EC)

Type

Multi-sectorial MRA.

Text

Please refer to the following web link of the Canadian Department of Foreign Affairs and International Trade (DFAIT) for the texts of the Agreement and of the Sectoral Annexes, including the Drugs GMP Compliance Programme Sectoral Annex.( Next link will open in a new window http://www.dfait-maeci.gc.ca/tna-nac/mralst-en.asp). You can also refer to the following web link of the European Community for additional information on MRAs: http://pharmacos.eudra.org/F2/mra/index.htm

Key Dates

Ratification: September 1998
Start of confidence building exercise: November 1998
Start of operational phase:
- February 2003 (with original Member States only)
- June 1^st 2006 : Hungary and Czech Republic
Accession of 10 new Member States* to the European Community: May 2004

Evaluation of the Regulatory Authorities in the new Member States: ongoing

* The 10 new Member States are: Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic, and Slovenia. As the Health Products and Food Branch (HPFB) Inspectorate has already been found equivalent by the European Community (EC), Canadian fabricators benefit, as of May 1st 2004, from the same MRA exemptions when exporting their products to the new Member States. Until such time that the Regulatory Authorities (RA) of the new EC Member States have been evaluated and found equivalent by HPFB Inspectorate, and in order to be able to export to Canada under the MRA, the new Member States will be able to ask for the assistance of Member States' regulatory authorities already found equivalent to conduct the GMP inspection.

Product Scope - Coverage

Human and veterinary medicinal/drug products.

The list of products covered by the Agreement is given below:

human pharmaceuticals including prescription and non-prescription drugs, and medicinal gases;
human biologicals including vaccines, 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.

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", 10 new Member States have joined on May 1^st 2004. We will need to evaluate and find equivalent their respective RAs 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 RAs found equivalent. Unless specified under "Scope", they cover both human and veterinary drugs. 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".

Austria

RA: Bundesministerium für Gesundheit und Frauen.
"Federal Ministry for Health and Women'"

RA: Österreichische Agentur für Gesundheit and Ernährungssicherheit GmbH
"Austrian Agency for Health and Food Safety (AGES)"

Belgium

AR : Federale Overheidsdienst Volksgezondheid, Veiligheid van de Voedselketenen en Leefmilieu
"Federal Public Service Public Health, Food Chain Safety and Environment"

Czech Republic

RA: State Institute for Drug Control
Státní Ústav pro Kontrolu Léèiv (SÚKL)
Scope: human drugs

RA: Institute for State Control of Veterinary Biologicals and Medicaments
Ústav pro Státní Kontrolu Veterinárních Biopreparátù a Léèiv (ÚSKVBL)
Scope: veterinary drugs

Denmark

RA: Laegemiddelstyrelsen.
"Danish Medicines Agency".

Finland

RA: Lääkelaitos Läkemedelsverket.
"National Agency for Medicines (NAM)".

France

RA: Agence française de sécurité sanitaire des produits de santé (AFSSAPS).
"French Health Products Safety Agency".
Scope: human drugs.

RA: Agence nationale du médicament vétérinaire (ANMV).
"French Agency for Veterinary Medicinal Products".
Scope: veterinary drugs.

Germany

For Germany, 17 RAs and 32 inspectorates were identified. The 17 RAs are the Bundesministerium für Gesundheit und Soziale Sicherung and the 16 Länder level Supreme Authorities / Ministries. The federal ministry is responsible for the legislation falling within the scope of the MRA. 13 of the Länder delegate the responsibility of conducting GMP inspections to 29 District Authorities. The Länder level Regulatory Authorities are responsible for supervision of the delegated subordinates.

RA: Bundesministerium für Gesundheit und Soziale Sicherung (Bonn, Nordrhein-Westfalen).
"Federal Ministry of Health and Social Security".
"Ministère fédéral de la Santé et de la Sécurité sociale". (Bonn, Nordrhein-Westfalen).

RA: Baden-Württemberg - Sozialministerium Baden-Württemberg(Stuttgart).
Delegated District Authority (1): Regierungspräsidium Tübingen Leitstelle Arzneimittelüberwachung (Tübingen)

RA: Bayern - Bayerisches Staatsministerium für Umwelt, Gesundheit, und Verbraucherschutz. (München).
Delegated District Authorities (7): Regierung von Mittelfranken (Ansbach), Regierung von Niederbayern (Landshut), Regierung von Oberbayern (München), Regierung von Oberfranken (Bayreuth), Regierung der Oberpfalz (Regensburg), Regierung von Schwaben (Augsburg), Regierung von Unterfranken (Würzburg).

RA: Berlin - Senatsverwaltung für Gesundheit, Soziales und Verbraucherschutz (Berlin).
Delegated District Authority (1): Landesamt für Arbeitsschutz, Gesundheitsschutz und technische Sicherheit Berlin.(Berlin)

RA: Brandenburg - Human drugs: Ministerium für Arbeit, Soziales, Gesundheit und Frauen des Landes Brandenburg (Potsdam). Veterinary drugs Ministerium für ländliche Entwicklung, Umwelt und Verbraucherschutz.
Delegated District Authorities (2): Human drugs (1): Landesamt für Soziales und Versorgung (Potsdam). Veterinary drugs (1): Landesamt für Verbraucherschutz und Landwirtschaft.

RA: Bremen - Senator für Arbeit, Frauen, Gesundheit, Jugend und Soziales der Freien Hansestadt Bremen (Bremen).
Delegated District Authority (0): none.

RA: Hamburg - Behörde für Wissenschaft und Gesundheit Hamburg, (Hamburg).
Delegated District Authority (0): none.

RA: Hessen - Human drugs: Hessisches Sozialministerium (Wiesbaden). Veterinary drugs: Hessisches Ministerium für Umwelt, ländlichen Raum und Verbraucherschutz (Wiesbaden).
Delegated District Authorities(3) - Human and veterinary drugs - Regierungspräsidium Darmstadt (Darmstadt), Regierungspräsidium Gießen (Gießen), Regierungspräsidium Kassel (Kassel)

RA: Mecklenburg-Vorpommern - Sozialministerium Mecklenburg-Vorpommern (Schwerin).
Delegated District Authority (1): Arzneimittelüberwachungs- und -prüfstelle Mecklenburg-Vorpommern (Schwerin).

RA: Niedersachsen - Niedersächsisches Ministerium für Soziales, Frauen, Familie und Gesundheit (Hannover).
Delegated District Authorities (4): Gewerbeaufsichtsamt Braunschweig (Braunschweig ), Gewerbeaufsichtsamt Hannover (Hannover), Gewerbeaufsichtsamt Lüneburg (Lüneburg), Gewerbeaufsichtsamt Oldenburg (Oldenburg).

RA: Nordrhein-Westfalen - Human drugs: Ministerium für Gesundheit, Soziales, Frauen und Familie des Landes Nordrhein-Westfalen (Dusseldorf). Veterinary drugs: Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen (Düsseldorf).
Delegated District Authorities (5): Bezirksregierung Arnsberg (Arnsberg), Bezirksregierung Detmold (Detmold), Bezirksregierung Düsseldorf (Düsseldorf), Bezirksregierung Köln (Köln), Bezirksregierung Münster (Münster).

RA: Rheinland Pfalz - Ministerium für Arbeit, Soziales, Familie und Gesundheit (Mainz).
Delegated District Authority (1): Landesamt für Soziales, Jugend und Versorgung, Koblenz (Koblenz).

RA: Saarland: Ministerium für Justiz, Gesundheit und Soziales des Saarlandes (Saarbrücken).
Delegated District Authority (0): none.

RA: Sachsen - Sächsisches Staatsministerium für Soziales (Dresden).
Delegated District Authority (1): Regierungspräsidium Dresden (Dresden).

RA: Sachsen-Anhalt - Ministerium für Gesundheit und Soziales des Landes Sachsen-Anhalt (Magdeburg).
Delegated District Authority (1): Landesverwaltungsamt Sachsen-Anhalt (Halle an der Saale).

RA: Schleswig-Holstein - Ministerium für Soziales, Gesundheit und Verbraucherschutz des Landes Schleswig-Holstein (Kiel).
Delegated District Authority (1): Landesamt für Gesundheit und Arbeitssicherheit des Landes Schleswig-Holstein (Kiel).

RA: Thüringen - Thüringer Ministerium für Soziales, Familie und Gesundheit (Erfurt).
Delegated District Authority (1): Thüringer Landesamt für Lebensmittelsicherheit und Verbraucherschutz (Weimar).

Greece

Ethnikos Organismos Farmakon (EOF) - (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ)).
National Organization for Medicines

Hungary

RA: National Institute of Pharmacy
Országos Gyógyszerészeti Intézet (OGYI)
Scope: human drugs

RA: Institute for Veterinary Medicinal Products (IVMP)
Állatgyógyászati Oltóanyag-, Gyógyszer- és Takarmányellen rz Intézet (ÁOGYTI)
Scope: veterinary drugs

Ireland

RA: Irish Medicines Board (IMB).

Italy

RA: Agenzia Italia del Farmaco, Ministero della Salute
"Italian Medicines Agency, Ministry of Health"
Scope: human drugs.

RA: Direzione generale della sanità veterinaria edegli alimenti, Ministero della Salute
"Direction General of Veterinary Health and Food, Ministry of Health"
Scope: veterinary drugs.

Netherlands

RA: Inspectie voor de Gezondheidszorg, Ministerie van Volksgezondheid, Welzijn, en Sport.
"Health Care Inspectorate, Ministry of Public Health, Welfare and (VWS)".
Scope: human drugs.

RA: Bureau Diergeneesmiddelen (BD), Veterinary Medicinal Products Unit of the Agency of the Medicines Evaluation Board (MEB) Inspections delegated to:
Inspectie voor de Gezondheidszorg, Ministerie van Volksgezondheid, Welzijn, en Sport.
"Health Care Inspectorate, Ministry of Public Health, Welfare and Sport (VWS)".
and may involve:
Bureau Diergeneesmiddelen (BD), Veterinary Medicinal Products Unit of the Agency of the Medicines Evaluation Board (MEB)

Portugal

RA: Instituto Nacional da Farmácia e do Medicamento (INFARMED).

Spain

RA: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
"Spanish Agency of Medicines and Health Products"

Sweden

RA: Läkemedelsverket.
"Medical Products Agency (MPA)".

United Kingdom

RA: Medicines and Healthcare Products Regulatory Agency (MHRA).

Status Summary - Update

Operational phase - Update

Canada and the EC have completed with success the confidence building exercise for establishing mutual recognition. The agreement entered into operation on February 1^st, 2003, starting with the exchange of GMP compliance certificates.The new Member States that have joined the EC on May 1st 2004 will now have to be evaluated for equivalency.

The Canadian assessments of Hungarian and Czech Republic human and veterinary authorities were successful and they are now included in the list of equivalent authorities. The exchange of GMP certificates will start June 1^st, 2006.

Scope - Update

The MRA covers all medicinal products/drugs which are manufactured in Canada and in participating EC Member States, and to which GMP requirements apply in both jurisdictions. It should be noted that blood and blood components are excluded from the scope of the MRA. Parties have also agreed to temporarily exclude stable medicinal products derived from human blood or human plasma. This decision will be reconsidered later under the maintenance programme.

As of October 1^st 2004, the Pre-Authorization / Pre-Marketing GMP Inspections will be included under the scope of the MRA.

The inclusion of Manufactured Drugs used in Clinical Trials under the scope of the MRA is also confirmed. It is currectly limited to sites already holding a manufacturing authorisation / establishment licence.

It was agreed that for the moment Active Pharmaceutical Ingredients (APIs) would not fall under the scope of the MRA. EC has legislation in place since October 2005, while Canada is in the process of drafting regulations.

A new federal Natural Health Products Regulations governing Natural Health Products in Canada came into effect on January 1, 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, establishment licenses held by natural health product companies are considered expired and have not been renewed since January 2006. In order to bring these products back under 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 license issued based on compliance with pharmaceutical GMP. Further information is available at http://hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html. Health Canada will update EC of any progress in this matter.

MRA between Canada and Switzerland

Type

Multi-sectorial MRA.

Text

Key Dates

Ratification: October 1998
Start of the confidence building exercise: December 1998
Start of operational phase: June 2000

Product Scope - Coverage

The list of products covered by the Agreement is given below:

human pharmaceuticals including prescription and non-prescription drugs, and medicinal gases;
human biologicals including vaccines, 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.

Regulatory Authorities Involved

The following regulatory authorities of Switzerland have been found equivalent:

Swissmedic, Schweizerisches Heilmittelinstitut
Swissmedic, Institut suisse des produits thérapeutiques
Swissmedic, Istituto svizzero per gli agenti terapeutici
"Swissmedic, Swiss Agency for Therapeutic Products"

Inspections of biological manufactures are conducted by Swissmedic, whereas inspections for pharmaceutical manufacturers are delegated to the four regional inspectorates:

Regionales Heilmittelinspektorat der Nordwestschweiz
"Regional Medicines Inspectorate of Northwestern Switzerland"
Regionale Fachstelle der Ost- und Zentralschweiz
"Regional Medicines Inspectorate of Eastern and Central Switzerland"
Ispettorato Regionale dei Medicamenti della Svizzera del Sud
"Regional Medicines Inspectorate of Southern Switzerland"
ISOPTh (Inspectorat de Suisse Occidentale des Produits Therapeutiques)
"Regional Medicines Inspectorate of Western Switzerland"

Status Summary - Update

Canada and Switzerland have completed with success the 18-month confidence building exercise for establishing mutual recognition. The agreement entered into operation on June 1st, 2000, starting with the exchange of GMP compliance certificates.

Organizational changes within the Swiss authorities happened on January 1, 2002, resulting in the creation of the Swissmedic, the Swiss Agency for Therapeutic Products, a governmental body affiliated with the Federal Department of Home Affairs. A re-evaluation of Swissmedic was completed in November 2005. Swissmedic was found to have an equivalent GMP compliance program with that of Health Canada.

The MRA covers all human and veterinary medicinal products/drugs which are manufactured in Canada and in Switzerland, and to which GMP requirements apply in both jurisdictions. It should be noted that blood and blood components are excluded from the scope of the MRA. Parties have also agreed to temporarily exclude stable medicinal products derived from human blood or human plasma. This decision will be reconsidered later under the maintenance programme.

MRA between Canada and the European Economic Area - European Free Trade Association (EEA-EFTA) Member States

Type

Multi-sectorial MRA.

Text

Please refer to the web site of the Canadian Department of Foreign Affairs and International Trade (DFAIT) for the texts of the Agreement and of the Sectoral Annexes, including the Drugs GMP Compliance Programme Sectoral Annex. Next link will open in a new window http://www.dfait-maeci.gc.ca/tna-nac/mralst-en.asp

Key Dates

Ratification: November 2000
Start of confidence building exercise: January 2001
Start of operational phase: November 1^st, 2002

Product Scope - Coverage

The MRA covers all medicinal products/drugs which are manufactured in Canada and in the EEA-EFTA countries, and to which GMP requirements apply in both jurisdictions. It should be noted that blood and blood components are excluded from the scope of the MRA. Parties have also agreed to temporarily exclude stable medicinal products derived from human blood or human plasma. This decision will be reconsidered later under the maintenance programme.

The list of products covered by the agreement is given below:

human pharmaceuticals including prescription and non-prescription drugs, and medicinal gases;
human biologicals including vaccines, biotherapeutics, and immunologicals;
human radiopharmaceuticals;
veterinary pharmaceuticals, including prescription and non-prescription drugs, and pre-mixes for the preparation of veterinary medicated feeds;
vitamins, minerals, herbal remedies and homeopathic medicinal products.

Regulatory Authorities Involved

The following regulatory authorities of the three EEA EFTA States have been found equivalent:

Iceland
RA: Lyfjastofnun
"Icelandic Medicines Control Agency"
RA: Heilbrigðis- og tryggingamálaráðuneytið
"Icelandic Ministry of Health and Social Security"

Liechtenstein
RA: Kontrollstelle für Arzneimittel
"Monitoring Agency for Medicinal Products"

Norway
RA: Statens Legemiddelverk
"Norwegian Medicines Agency"

Status Summary - Update

The 18-month confidence building exercise has been completed and the Joint Committee has accepted the report from the Joint Sectoral group in October 2002. The agreement entered into operation on November 1st, 2002, starting with the exchange of GMP compliance certificates.

MRA between Canada and Australia

Type

Single sector MRA.

Text

The text of this Agreement and of the Sectoral Annexes, including the Drugs GMP Compliance Programme Sectoral Annex will be available on the web site of the Canadian Department of Foreign Affairs and International Trade (DFAIT) in the second half of this fiscal year. (http://www.dfait-maeci.gc.ca/tna-nac/mralst-en.asp)

Key Dates

Ratification: March 16, 2005
Start of confidence building exercise: October 2001
Start of the operational phase: January 1^st, 2006

Product Scope - Coverage

This Agreement applies to the all medicines which in Australia/ Canada are subject to a GMP compliance program. These include:

human pharmaceuticals such as prescription and non-prescription medicines/ drugs and medical gases;
human biologicals including vaccines, immunologicals, and biotherapeutics; and
human radiopharmaceuticals

This Agreement does not apply to the following products/ processes:

blood and blood components;
tissues and organs of animal or human origin;
official release of biologicals;
stable medicines/ drugs derived from blood or plasma; or
veterinary pharmaceuticals, including sterile and non-sterile veterinary pharmaceuticals.

This Agreement doe not apply to pre-approval inspections.

Regulatory Authority Involved

The Therapeutic Goods Administration (TGA) of Australia.

Status Summary - Update

Canada and Australia completed with success the confidence building phase established to recognize the equivalency of the GMP compliance program. On March 16, 2005 the Australia - Canada MRA Treaty was signed. The operational phase began on January 1st, 2006 with the exchange of GMP compliance certificates.

The MRA covers all medicinal products/drugs manufactured in Canada and Australia, and where the applicable GMP requirements apply in both jurisdictions. It should be noted that blood, blood components and stable medicinal products derived from human blood or human plasma are excluded from the scope of the MRA.


	Last Updated: 2006-08-28		Important Notices