Mutual Recognition Agreement Regulatory Authorities
Date of last update: January 6, 2022
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 (HALMED) "Agency for Medicinal Products and Medical Devices" |
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, Rural Development and Environment" |
no | yes |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Státní ústav pro kontrolu liéčiv (SÚKL) "State Institute for Drug Control" |
yes | no |
| Ústav pro Státní Kontrolu Veterinárních Biopreparátù a liéčiv (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 Soziales, Gesundheit und Integration Baden-Württemberg (Stuttgart) |
Regierungspräsidium Tübingen | Tübingen | yes | yes |
| Bayern | Bayerisches Staatsministerium für Gesundheit und Pflege (München) |
Regierung von Oberbayern | München | yes | yes |
| Regierung von Oberfranken | Bayreuth | yes | yes | ||
| Berlin | Senatsverwaltung für Gesundheit Pflege und Gleichstellung (Berlin) |
Landesamt für Gesundheit und Soziales Berlin | Berlin | yes | yes |
| Brandenburg | Human: Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz des Landes Brandenburg, Abteilung 1 (Postdam) |
Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit Potsdam | Potsdam | yes | no |
| Veterinary: Ministerium für Soziales, Gesundheit, Integration und Verbraucherschutz des Landes Brandenburg, Abteilung 3 (Postdam) |
Landesamt für Arbeitsschutz, Verbraucherschutz und Gesundheit | Potsdam | no | yes | |
| Bremen | Die Senatorin für Gesundheit, Frauen und Verbraucherschutz (Bremen) |
Die Senatorin für Gesundheit und Verbraucherschutz Bremen |
Bremen | yes | yes |
| Hamburg | Behörde für Justiz und Verbraucherschutz der Freien und Hansestadt Hamburg (Hamburg) |
Behörde für Justiz 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 Soziales, Gesundheit und Sport, Mecklenburg-Vorpommern (Schwerin) |
Landesamt für Gesundheit und Soziales Mecklenburg-Vorpommern Arzneimittelüberwachungs- und -prüfstelle |
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 Arbeit, Gesundheit und Soziales 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, Umwelt, Landwirschaft, Natur und Verbraucherschutz des Landes Nordrhein-Westfalen (Düsseldorf) |
Landesamt für Natur, Umwelt und Verbraucherschutz Nordrhein-Westfalen | Reckling-hausen | no | yes | |
| Rheinland- Pfalz |
Ministerium für Wissenschaft und Gesundheit (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 Gesellschaftlichen Zusammenhalt (Dresden) |
Landesdirektion Sachsen | Leipzig | yes | yes |
| Sachsen- Anhalt |
Ministerium für Arbeit, Gesundheit und Gleichstellung (Magdeburg) |
Landesverwaltungsamt Sachsen-Anhalt | Halle (Saale) |
yes | yes |
| Veterinary: Ministerium für Wirtschaft, Tourismus, Landwirtschaft und Forsten (Magdeburg) |
|||||
| Schleswig- Holstein |
Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren des Landes Schleswig-Holstein (Keil) |
Landesamt für soziale Dienste Schleswig-Holstein |
Neumünster | 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 |
|---|---|---|
|
Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) "National Institute of Pharmacy and Nutrition" |
yes | no |
| Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (NEBIH ÁTI) "National Food Chain Safety 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 / Direzione Generale della Sanità Animale e dei Farmaci Veterinari "Ministry of Health / Direction General for Animal Health and Veterinary Medicinal Products" |
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 Regulatory Authority | yes | no |
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Inspectie Gezondheidszorg en Jeugd (IGJ) "Health and Youth 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) "Chief Pharmaceutical Inspectorate (CPI)" |
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 of the Republic of Slovenia" |
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 |
| Delegated Regional Inspectorates: | ||
| Regionales Heilmittelin-spektorat der Nordwestschweiz (RHI NW) "Regional Medicines Inspectorate of Northwestern Switzerland" |
yes | yes |
| Regionale Fachstelle der Ost- und Zentralschweiz (RFS-OZ) "Regional Medicines Inspectorate of Eastern and Central Switzerland" |
yes | yes |
| Ispettorato regionale die medicamenti della Svizzera del Sud (IRM-S) "Regional Medicines Inspectorate of Southern Switzerland" |
yes | yes |
| Inspectorat de Suisse occidentale des produits thérapeutiques (ISOPTh) "Regional Medicines Inspectorate of Western Switzerland" |
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 Authorities 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".
| Regulatory Authorities | Human | Veterinary |
|---|---|---|
| Medicines and Healthcare Products Regulatory Agency (MHRA) | yes | no |
| Veterinary Medicines Directorate (VMD) | no | yes |
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