The Spanish Agency of Medicines and Medical Devices ( es, Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a

regulatory Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...

and autonomous agency of the

Government of Spain gl, Goberno de España eu, Espainiako Gobernua , image = , caption = Logo of the Government of Spain , headerstyle = background-color: #efefef , label1 = Role , data1 = Executive power , label2 = Established , da ...

that acts as the highest sanitary authority in the country in terms of medical safety on

medicines A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and re ...

, health products,

cosmetics Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect ...

and

personal care products Personal care or toiletries are consumer products used in personal hygiene, personal grooming or for beautification. Products Personal care includes products as diverse as cleansing pads, colognes, cotton swabs, cotton pads, deodorant, eye line ...

. 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 European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

(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. Since 1998, the agency has powers over the control, evaluation and authorization of animal health products. The agency was created under the name of ''Agencia Española del Medicamento'' by the Fiscal, Administrative and Social Order Measures Act of 1997 and its powers were extended (to fields such as

veterinary drugs An animal drug (also veterinary drug) refers to a drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Regulation United States The U.S. Food and Drug Administration (FDA) has the broad mandat ...

) 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. It was renamed as ''Agencia Española de Medicamentos y Productos Sanitarios'' in August 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 Agriculture or farming is the practice of cultivating plants and livestock. Agriculture was the key development in the rise of sedentary human civilization, whereby farming of domesticated species created food surpluses that enabled people to ...

. 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. * 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.

References

;Citations ;Bibliography * * {{authority control Government agencies of Spain Government agencies established in 1997 National agencies for drug regulation 1997 establishments in Spain

Organization chart

See also

References