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  1. International Arrangements

European Union (EU) Mutual Recognition Agreement

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The U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) MRA entered into force on November 1, 2017. Initially the agreement included only pharmaceuticals intended for human use. On May 31, 2023 the U.S. Food and Drug Administration (FDA) and the European Union (EU) announced their decision to expand the scope of the MRA to include inspections of veterinary pharmaceuticals. To date, the FDA has completed capability for all 27 of the EU countries' human drug regulatory authorities, and 18 of the EU countries’ veterinary drug regulatory authorities. 

FDA also has MRAs in force with Switzerland and the United Kingdom.

Country Regulatory authority for medicinal products for human and/or veterinary use* Type Date Recognized
Austria Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit (GmbH)

Human Drugs

Animal Drugs

November 1, 2017

May 30, 2023

Belgium Federal agency for medical and health products / Fedraal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé

Human Drugs

Animal Drugs

November 16, 2018

May 30, 2023

Bulgaria Bulgarian Drug Agency
ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА
Human Drugs April 29, 2019
Bulgaria Bulgarian Food Safety Agency / Българска агенция по безопасност на храните**** Animal Drugs May 30, 2023
Croatia Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED)

Human Drugs

November 1, 2017
Cyprus

The Cyprus Council of Veterinary Medicinal Products (CyCVMPs) – The Veterinary Services*****

Animal Drugs October 8.2024
Cyprus Ministry of Health – Pharmaceutical Services
Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας
Human Drugs April 29, 2019
Czech Republic Institute for State Control of Veterinary Biologicals and Medicines / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (USKVBL) Animal Drugs October 18, 2024
Czech Republic State Institute for Drug Control Human Drugs March 1, 2018
Denmark Danish Medicines Agency / Laegemiddelstyrelsen

Human Drugs

Animal Drugs

November 16, 2018

May 30, 2023

Estonia State Agency of Medicines / Ravimiamet

Human Drugs

Animal Drugs

November 28, 2019

May 30, 2023

Finland Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA)

Human Drugs

Animal Drugs

November 16, 2018

May 30, 2023

France French National Agency for Medicines and Health Products Safety / Agence nationale de sécurité du medicament et des produits de santé Human Drugs November 1, 2017
France  French Agency for Food, Environmental and Occupational Health & Safety – French Agency for Veterinary Medicinal Products / Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail – Agence nationale du médicament vétérinaire (Anses-ANMV) Animal Drugs May 30, 2023
Germany Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)

Human Drugs

Animal Drugs

June 26, 2019

August 7, 2024

Greece National Organisation for Medicines

Human Drugs

Animal Drugs

March 1, 2018

May 30, 2023

Hungary

National Institute of Pharmacy and Nutrition Human Drugs March 1, 2018
Hungary National Food Chain Safety Office, Directorate of Veterinary Medicinal Products / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) Animal Drugs May 30, 2023

Ireland

Health Products Regulatory Authority (HPRA)

Human Drugs

Animal Drugs

June 1, 2018

May 30, 2023

Italy Italian Medicines Agency / Agenzia Italiana del Farmaco Human Drugs November 1, 2017

Latvia

State Agency of Medicines / Zāļu valsts aģentūra Human Drugs November 16, 2018
Latvia Food and Veterinary Service Animal Drugs November 28,2023
Lithuania

State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba

Human Drugs

June 1, 2018

Lithuania State Food and Veterinary Service / Valstybine maisto ir veterinarijos tarnyba Animal Drugs July 18, 2024
Luxembourg Minìstere de la Santé, Division de la Pharmacie et des Médicaments

Human Drugs

Animal Drugs

June 10, 2019

May 30, 2023

Malta Medicines Regulatory Authority*** Human Drugs November 1, 2017
Netherlands Healthcare Inspectorate / Inspectie voor de Gezondheidszorg (IGZ) Human Drugs June 10, 2019
Netherlands Medicines Evaluation Board (MEB) / College ter Beoordeling van Geneesmiddelen (CBG) Veterinary Medicinal Products Unit / Bureau Diergeneesmiddelen Animal Drugs May 30, 2023
Poland The Main Pharmaceutical Inspectorate/
Główny Inspektorat Farmaceutyczny (GIF)

Human Drugs

Animal Drugs

February 7, 2019

May 30, 2023

Portugal

National Authority of Medicines and Health Products / INFARMED, I.P / Autoridade Nacional do Medicamento e Produtos de Saúde, I.P

Human Drugs

September 14, 2018

Portugal General Directorate of Food and Veterinary / Direção-Geral de Alimentação e Veterinária (DGAV) Animal Drugs May 30, 2023
Romania National Agency for Medicines and Medical Devices Human Drugs March 1, 2018
Slovakia State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL)** Human Drugs July 11, 2019
Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

Human Drugs

Animal Drugs

February 7, 2019

May 30, 2023

Spain Spanish Agency of Medicines and Medical Devices/ Agencia Española de Medicamentos y Productos Sanitarios

Human Drugs

Animal Drugs

November 1, 2017

May 30, 2023

Sweden Medical Products Agency / Läkemedelsverket

Human Drugs

Animal Drugs

November 1, 2017

September 26, 2023

United States Food and Drug Administration

Human Drugs

Animal Drugs

November 1, 2017

May 30, 2023

 

*Limitations: The capability determinations apply to routine surveillance inspections. In the future the following product and inspection types may be included in the coverage of the agreement, pending further consideration:

  • Vaccines for human use
  • Plasma derived pharmaceuticals
  • Investigational products (clinical trial material), specific to each agreement

The FDA and the EU have considered the issue of expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use. FDA has decided to consider the issue again in July 2025 based on further assessment.

Excluded from the MRA scope are: Advanced Therapy Medicinal Products (ATMPs), human blood, human plasma, human tissues and organs, and veterinary immunologicals.

** Malta – capability for human medicines excludes sterile or aseptically processed drugs and biological products; and nonsterile, highly potent drug products.

*** Slovakia – for human medicines only for inspections of chemically synthesized active pharmaceutical ingredients intended for use in drug products for human oral administration and manufactured in a dedicated, single product facility.

**** Bulgaria – capability for veterinary products excludes sterile veterinary drug products.

***** Cyprus – capability for veterinary products excludes sterile or aseptically processed drugs and biological products; and nonsterile, highly potent drug products.

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