Spanish Agency of Medicines and Medical Devices

Spanish Agency of Medicines and Medical Devices
Agencia Española de Medicamentos y Productos Sanitarios
Agency overview
FormedDecember 30, 1997; 26 years ago (1997-12-30)
JurisdictionSpain
HeadquartersParque Empresarial Las Mercedes, Calle Campezo 1, Madrid, Spain
Employees524 (2019)
Annual budget€ 85.5 million, 2023[1]
Agency executives
Parent agencyMinistry of Health
Websitewww.aemps.gob.es

The Spanish Agency of Medicines and Medical Devices (Spanish: Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the country in terms of medical safety on medicines, health products, cosmetics and personal care products.

The agency is responsible for the regulation and authorization of clinical trials and the commercialization of sanitary products for human use, the planification and evaluation of those products along with the European Medicines Agency (EMA); the authorization of clinical laboratories, develop the specific rules to ensure the quality of the medical products and inspect all sanitary products of the central government competence.[2] Since 1998, the agency has powers over the control, evaluation and authorization of animal health products.[3]

The agency was created under the name of Agencia Española del Medicamento[4] by the Fiscal, Administrative and Social Order Measures Act of 1997 and its powers were extended (to fields such as veterinary drugs)[5] by another law of the same name from 1998 and by the Cohesion and Quality of the National Health System Act of 2003. The statute of the agency was approved in 1999.[4] It was renamed as Agencia Española de Medicamentos y Productos Sanitarios in August 2003.[5] It depends directly from the Ministry of Health.

The agency is chaired by a President and a Vice President. Both officials are Under Secretaries of the Ministry of Health and Agriculture. The real chief executive of the agency is the Director.

  1. ^ "State Budget 2021" (PDF).
  2. ^ "Fiscal, Administrative and Social Order Measures Act of 1997". www.boe.es. Retrieved 2019-02-10.
  3. ^ "Fiscal, Administrative and Social Order Measures Act of 1998". www.boe.es. Retrieved 2019-02-10.
  4. ^ a b Vidal Casero 2000, p. 98.
  5. ^ a b Palop Baixauli 2004, p. 99.