AEMPS - Spanish Agency of Medicine and Sanitary Products

The Spanish Agency for Medicine and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS) is the regulatory agency that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in Spain. It was founded in 1999 to replace the Spanish Pharmacy and Medical Devices Administration (Dirección General de Farmacia y Productos Sanitarios) and the Spanish Centre for Pharmacobiology (Centro Nacional de Farmacobiologia). Its activities were established under Law 29/2006 of 26th of July.

The agency within the Ministry of Health and Social Policy authorizes and controls medicines for human and veterinary use, cosmetics, medical devices, hygiene products, and clinical trials, as well as oversees supply and access. Apart from overseeing public health in Spain, the AEMPS is the certifying authority for medical devices in the EU, acting as a representative of the European agencies’ network and the European Medicines Agency.

A list of EU regulations can be found here on our website.

Contact details:

• Website: http://www.msssi.gob.es/en/home.htm

Medical Device Associations in Spain:

• Federacion Española de Empresas de Technologia Sanitarial (FENIN)
• Sociedad Española de Implantes (SEI)