Mutual Recognition Agreement Regulatory Authorities
Date of last update: August 19th, 2021
Regulatory Authorities of the EU involved in the MRA with Canada
Please note that the Regulatory Authorities 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 "English equivalent".
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Bundesamt für Sicherheit im Gesundheitswesen "Federal Office for Safety in Health Care, BASG" Note: Regulatory Authority |
yes | yes |
| AGES GmbH (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH) "Austrian Agency for Health and Food Safety (AGES) / PharmMed Austria" Note: Delegated Inspectorate |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) "Federal Agency for Medicines and Health Products (FAMHP)" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Agencija za lijekove i medicinske proizvode " Agency for Medicinal Products and Medical Devices of Croatia (HALMED)" |
yes | no |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας "Pharmaceutical Services, Ministry of Health" |
yes | no |
| Κτηνιατρικές Υπηρεσίες, Υπουργείο Γεωργίας "Veterinary Services, Ministry of Agriculture Natural Resources and Environment" |
no | yes |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Státní Ústav pro Kontrolu Léciv (SÚKL) "State Institute for Drug Control" |
yes | no |
| Ústav pro Státní Kontrolu Veterinárních Biopreparátù a Léciv (ÚSKVBL) "Institute for State Control of Veterinary Biologicals and Medicaments" |
no | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Laegemiddelstyrelsen "Danish Health and Medicines Authority" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Ravimiamet "State Agency of Medicines (SAM)" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Lääkealan turvallisuus- ja kehittämiskeskus "Finnish Medicines Agency, FIMEA" |
yes | yes |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Agence nationale de sécurité du médicament et des produits de santé (ANSM) "The French National Agency for Medicines and Health Products Safety" |
yes | no |
| Agence nationale du médicament vétérinaire (ANMV) "National Agency for Veterinary Medicinal Products" |
no | yes |
| Land - - - Länder |
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) | City | Human | Veterinary | |
|---|---|---|---|---|---|
| Supreme Authority/ Ministry (city) | Responsible Authorities | ||||
| Baden- Württemberg |
Ministerium für Arbeit und Sozialordnung, Familie, Frauen und Senioren Baden-Württemberg (Stuttgart) |
Regierungspräsidium Tübingen | Tübingen | yes | yes |
| Bayern | Bayerisches Staatsministerium für Umwelt und Gesundheit (München) |
Regierung von Oberbayern | München | yes | yes |
| Berlin | Senatsverwaltung für Gesundheit und Soziales (Berlin) |
Landesamt für Gesundheit und Soziales Berlin | Berlin | yes | yes |
| Brandenburg | Human: Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie des Landes Brandenburg (Postdam) |
Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Zossen | Zossen | yes | no |
| Veterinary: Ministerium der Justiz und für Europa und Verbraucherschutz des Landes Brandenburg (Postdam) |
Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit | Potsdam | no | yes | |
| Bremen | Die Senatorin für Wissenschaft, Gesundheit und Verbraucherschutz der Freien Hansestadt (Bremen) |
Die Senatorin für Wissenschaft, Gesundheit und Verbraucherschutz der Freien Hansestadt Bremen |
Bremen | yes | yes |
| Hamburg | Behörde für Gesundheit und Verbraucherschutz der Freien und Hansestadt Hamburg (Hamburg) |
Behörde für Gesundheit und Verbraucherschutz der Freien und Hansestadt Hamburg | Hamburg | yes | yes |
| Hessen | Human: Hessisches Ministerium für Soziales und Integration (Wiesbaden) |
Regierungspräsidium Darmstadt | Darmstadt | yes | no |
| Veterinary: Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz (Weisbaden) |
Regierungspräsidium Darmstadt | Darmstadt | no | yes | |
| Mecklenburg- Vorpommern |
Ministerium für Arbeit, Gleichstellung und Soziales Mecklenburg-Vorpommern (Schwerin) |
Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern | Schwerin | yes | yes |
| Niedersachsen | Niedersächsisches Ministerium für Soziales, Gesundheit und Gleichstellung (Hannover) |
Staatliches Gewerbeaufsichtsamt Braunschweig | Braun-schweig | yes | yes |
| Staatliches Gewerbeaufsichtsamt Hannover | Hannover | yes | yes | ||
| Staatliches Gewerbeaufsichtsamt Lüneburg | Lüneburg | yes | yes | ||
| Staatliches Gewerbeaufsichtsamt Oldenburg | Oldenburg | yes | yes | ||
| Nordrhein- Westfalen |
Human: Ministerium für Gesundheit, Emanzipation, Pflege und Alter des Landes Nordrhein-Westfalen (Düsseldorf) |
Bezirksregierung Arnsberg | Arnsberg | yes | no |
| Bezirksregierung Detmold | Detmold | yes | no | ||
| Bezirksregierung Düsseldorf | Düsseldorf | yes | no | ||
| Bezirksregierung Köln | Köln | yes | no | ||
| Bezirksregierung Münster | Münster | yes | no | ||
| Veterinary: Ministerium für Klimaschutz, Umwelt, Landwirschaft- und Verbraucherschutz des Landes Nordrhein-Westfalen (Düsseldorf) |
Landesamt für Natur, Umwelt und Verbraucherschutz Nordrhein-Westfalen | Düsseldorf and Reckling-hausen | no | yes | |
| Rheinland- Pfalz |
Ministerium für Soziales, Arbeit, Gesundheit und Demografie Rheinland-Pfalz (Mainz) |
Landesamt für Soziales, Jugend und Versorgung | Koblenz | yes | yes |
| Saarland | Ministerium für Soziales, Gesundheit, Frauen und Familie des Saarlandes (Saarbrücken) |
Ministerium für Soziales, Gesundheit, Frauen und Familie des Saarlandes | Saarbrücken | yes | yes |
| Sachsen | Sächsisches Staatsministerium für Soziales und Verbraucherschutz (Dresden) |
Landesdirektion Sachsen | Leipzig | yes | yes |
| Sachsen- Anhalt |
Ministerium für Arbeit, Soziales und Integration Sachsen-Anhalt (Magdeburg) |
Landesverwaltungsamt Sachsen-Anhalt | Halle (Saale) |
yes | yes |
| Schleswig- Holstein |
Ministerium für Soziales, Gesundheit, Wissenschaft und Gleichstellung des Landes Schleswig-Holstein (Keil) |
Landesamt für soziale Dienste Schleswig-Holstein |
Kiel | yes | yes |
| Thüringen | Thüringer Ministerium für Arbeit, Soziales, Gesundheit, Frauen und Familie (Erfurt) |
Thüringer Landesamt für Verbraucherschutz | Bad Langensalza | yes | yes |
Supreme authorities are responsible for medicinal products and supervision of responsible subordinate authorities, covers both human and veterinary medicinal products (as defined in the scope of the MRA EC-Canada) unless otherwise indicated. |
|||||
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Ethnikos Organismos Farmakon (EOF) - (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ)) "National Organization for Medicines" |
yes | yes |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Gyógyszerészeti és Egészségügyi Minoség - és Szervezetfejlesztési Intézet Országos Gyógyszerészeti Intézet Foigazgatósága (GYEMSZI-OGYI) "National Institute for Quality - and Organizational Development in Healthcare and Medicines" |
yes | no |
| Állatgyógyászati Termékek Igazgatósága (ÁTI) "Central Agricultural Office, Directorate of Veterinary Medicinal Products (DVMP)" |
no | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Health Products Regulatory Authority (HPRA) | yes | yes |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Agenzia Italia del Farmaco (AIFA), Ministero della Salute "Italian Medicines Agency, Ministry of Health" |
yes | no |
| Ministero della Salute / Dipartimento per la Sanità Pubblica Veterinaria, la Nutrizione e la Sicurezza degli Alimenti / Direzione Generale della Sanità Animale e del Farmaco Veterinario "Ministry of Health / Department of Veterinary Public Health, Nutrition and Food Safety / Direction General of Animal Health and Veterinary Drug" |
no | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos "State Medicines Control Agency" (SMCA) |
yes | no |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Medicines Authority | yes | no |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Inspectie voor de Gezondheidszorg (IGZ) "Health Care Inspectorate" |
yes | no |
| Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG) "Veterinary Medicinal Products Unit, Medicines Evaluation Board (MEB)" Note: Regulatory Authority |
no | yes |
| Inspectie voor de Gezondheidszorg, Ministerie van Volksgezondheid, Welzijn en Sport (VWS) "Health Care Inspectorate, Ministry of Health, Welfare and Sport (VWS)" Note: Delegated Inspectorate |
no | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Główny Inspektorat Farmaceutyczny (GIF) "Main Pharmaceutical Inspectorate (MPI)" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) "National Authority of Medicines and Health Products" |
yes | no |
| Direcção-Geral de Alimentação e Veterinária (DGAV) "General Directorate of Food and Veterinary" |
no | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Agentia Nationala a Medicamentului si a Dispozitivelor Medicale (ANMDM) "National Agency for Medicines and Medical Devices (NAMMD)" |
yes | no |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Štátny ústav pre kontrolu liečiv (SUKL) "State Institute for Drug Control (SIDC)" |
yes | no |
| Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL), Ministerstvo pôdohospodárstva "Institute for State Control of Veterinary Biologicals and Medicaments (ISCVBM), Ministry of Agriculture" |
no | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) "Agency for Medicinal Products and Medical Devices Slovenia (Human & Veterinary)" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) "Spanish Agency of Medicines and Health Products" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Läkemedelsverket "Medical Products Agency" |
yes | yes |
Regulatory Authority of Switzerland involved in the MRA with Canada
Please note that the Regulatory Authorities 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 "English equivalent".
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Schweizerisches Heilmittelinstitutm (Swissmedic) "Swiss Agency for Therapeutic Products" |
yes | yes |
Regulatory Authorities of EEA-EFTA involved in the MRA with Canada
Please note that the Regulatory Authorities 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 "English equivalent".
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Lyfjastofnun "Icelandic Medicines Agency" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Amt für Gesundheit (AG), Kontrollstelle für Arzneimittel "Office of Public Health, Medicinal Products Agency 1" |
yes | yes |
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Statens Legemiddelverk "Norwegian Medicines Agency" |
yes | yes |
Regulatory Authority of Australia involved in the MRA with Canada
Please note that the Regulatory Authorities 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 "English equivalent".
| Regulatory Authority | Human | Veterinary |
|---|---|---|
| Therapeutic Goods Administration (TGA) of Australia | yes | no |
Regulatory Authority of the United Kingdom involved in the MRA with Canada
Please note that the Regulatory Authorities 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 "English equivalent".
| United Kingdom Regulatory Authority | Human | Veterinary |
|---|---|---|
| Medicines and Healthcare Products Regulatory Agency (MHRA) | yes | no |
| Veterinary Medicines Directorate (VMD) | no | yes |
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