Spanish Agency of Medicines and Medical Devices

The Spanish Agency of Medicines and Medical Devices (AEMPS) is a regulatory agency of the Government of Spain that acts as the highest sanitary authority in terms of medical safety on medicines, health products, cosmetics and personal care products.

Spanish Agency of Medicines and Medical Devices
Agencia Española de Medicamentos y Productos Sanitarios
Agency overview
FormedDecember 30, 1997 (1997-12-30)
JurisdictionSpain
HeadquartersMadrid,  Spain
Agency executives
  • Faustino Blanco González, President
  • María Jesús Lamas Díaz, Director
Parent agencyMinistry of Health
Websitewww.aemps.gob.es

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; the authorization of clinical laboratories, develop the especific rules to ensure the quality of the medical products and inspect all sanitary products of the central government competence.[1] Since 1998, the agency has powers over the control, evaluation and authorization of animal health products.[2]

The agency was created by the Fiscal, Administrative and Social Order Measures Act of 1997 and its powers were extended by another law of the same name from 1998 and by the Cohesion and Quality of the National Health System Act of 2003. 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.

Organization chart

The agency is divided in six type of bodies: Governing bodies, executive bodies, control committees, administrative bodies, supporting bodies and complementary bodies.[3]

  • Governing bodies:
    • President. It's the Secretary-General for Health, with the rank of Under Secretary.
    • Vice President. It's the Secretary-General for Agriculture and Food, with the rank of Under Secretary.
    • Governing Board.
      • Control Committee.
  • Executive Body.
    • Director.
      • Support body to the executive body.
      • Administrative bodies.
        • General Secretariat.
        • Department for Drug Inspection and Control
        • Department for Medicinal Products for Human Use
        • Department for Health Products
        • Department for Veterinary Drugs
  • Complementary bodies. It is a series of organs made up of experts in specific subjects.
    • Medicinal Products for Human Use Committee
    • Safety of Medicinal Products for Human Use Committee
    • Veterinary Medicines Committee
    • Veterinary Medicines Safety Committee
    • Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use
    • Post-authorization Studies Coordination Committee
    • Technical Committee of the Spanish Pharmacovigilance System for Veterinary Drugs
    • Veterinary Medicines Availability Committee
    • Pharmacopoeia Committee and the National Formulary
    • Technical Inspection Committee
    • Coordination Committee of Peripheral Pharmaceutical Services
    • Health Products Committee
    • Expert Network Committee.

See also

References
  1. "Fiscal, Administrative and Social Order Measures Act of 1997". www.boe.es. Retrieved 2019-02-10.
  2. "Fiscal, Administrative and Social Order Measures Act of 1998". www.boe.es. Retrieved 2019-02-10.
  3. "Agencia Española de Medicamentos y Productos Sanitarios - La AEMPS - Estructura de la AEMPS y órganos". www.aemps.gob.es (in Spanish). Retrieved 2019-02-10.
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