Spanish Agency of Medicines and Medical Devices
- Faustino Blanco González, President
- María Jesús Lamas Díaz [es], Director
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.
Organization chart
The agency is divided in six type of bodies: Governing bodies, executive bodies, control committees, administrative bodies, supporting bodies and complementary bodies.[6]
- 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
- Director.
- 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
- Health care in Spain
- Spanish National Health System
- Pharmacoepidemiology
References
- Citations
- ^ "State Budget 2021" (PDF).
- ^ "Fiscal, Administrative and Social Order Measures Act of 1997". www.boe.es. Retrieved 2019-02-10.
- ^ "Fiscal, Administrative and Social Order Measures Act of 1998". www.boe.es. Retrieved 2019-02-10.
- ^ a b Vidal Casero 2000, p. 98.
- ^ a b Palop Baixauli 2004, p. 99.
- ^ "Agencia Española de Medicamentos y Productos Sanitarios - La AEMPS - Estructura de la AEMPS y órganos". www.aemps.gob.es (in Spanish). Archived from the original on 2018-07-23. Retrieved 2019-02-10.
- Bibliography
- Palop Baixauli, Ramón (2004). "El futuro del medicamento y el papel de la Agencia Española del Medicamento y Productos Sanitarios". Revista de Administración Sanitaria Siglo XXI. 2 (1): 95–102. ISSN 1696-1641.
- Vidal Casero, María del Carmen (2000). "La evolución de la reglamentación de los medicamentos desde la promulgación de la ley del medicamento en 1990. Periodo 1990-2000: su problemática" (PDF). DS: Derecho y Salud. 8 (2): 95–110. ISSN 1133-7400.
- v
- t
- e
| |
Inactive |
|
---|
- Bank of Spain
- National Intelligence Centre
- Spanish National Research Council
- National Statistics Institute
- National Securities Market Commission
- National Transplant Organization
- State Meteorological Agency
- State Vehicle Fleet
- Spanish Data Protection Agency
- Spanish Agency for International Development Cooperation
- Spanish Tax Agency
- National Agency for Quality Assessment and Accreditation
- Boletín Oficial del Estado
- Railway Safety Agency
- Spanish Aviation Safety and Security Agency
- Evaluation and Quality Agency
- State Research Agency
- Spanish Anti-Doping Agency
- Department of Homeland Security
- Intelligence Center for Counter-Terrorism and Organized Crime
- Maritime Safety and Rescue Society
- National Sports Council
- Spanish Agency of Medicines and Medical Devices
- Spanish Agency for Food Safety and Nutrition
- Food Information and Control Agency
- Tourism Institute of Spain
- National Institute for Aerospace Technology
- Directorate-General for Traffic
- Labour and Social Security Inspectorate
- National Institute for Safety and Health at Work
- Spanish Patent and Trademark Office
- Spanish Agricultural Guarantee Fund
- Centre for Political and Constitutional Studies
- Centre for Sociological Research
- Patrimonio Nacional
- Instituto Cervantes
- National Parks Autonomous Agency
- Institute for the Elderly and Social Services
- Institute of Youth
- Carlos III Health Institute
- Centre for Energy, Environmental and Technological Research
- Institute of Women
- Independent Authority for Fiscal Responsibility
- Nuclear Safety Council
- Institute of Cinematography and Audiovisual Arts
- Spanish Space Agency
- National Commission on Markets and Competition
- Spanish Executive Resolution Authority
- Spanish Agency for the Supervision of Artificial Intelligence
- National Institute of Public Administration