alexa Agencia Espanola de Medicamentos y Productos Sanitarios

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Agencia Espanola de Medicamentos y Productos Sanitarios

The Spanish Agency for Medicines and Sanitary Products ( AEMPS ), formerly known as AGEMED, is an Autonomous Agency of Spain created by Law 66/1997, of 30 December and whose powers extended Law 50/1998, under the Ministry of Health . Finally, Law 16/2003, Cohesion and Quality of the National Health System, determines that the evaluation and, where appropriate, authorization of health and cosmetic products are competencies of the Spanish Agency for Medicines and Health Products. The President of the Spanish Medicines Agency will be the Undersecretary of the Ministry of Health and Consumer Affairs. Its main functions are: • To grant marketing authorization for industrially manufactured medicines for human use, review and adjustments to those already marketed. • Participate in the planning and evaluation of medicinal products for human use that are authorized by the European Union through the European Medicines Agency (EMA). • Evaluate and authorize clinical trials and products undergoing clinical research. • Authorize pharmaceutical laboratories for medicinal products for human use. • Develop the Spanish system of pharmacovigilance . • Control medicines of state competence. • Manage the Royal Spanish Pharmacopoeia . • Competences relating to narcotic drugs and psychotropic drugs that are regulated by regulations. • Activities of evaluation, registration, authorization, inspection, monitoring and control of medicinal products for human and veterinary use and sanitary , cosmetic and personal hygiene products. • Evaluation of conformity of sanitary products as Notified Body number 0318 granting CE marking of conformity according to directives 93/42 / EEC, 90/385 / EEC and 98/79 / EC