August 6, 2019

What is the AEMPS

AEMPS: Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices)

The AEMPS is the equivalent body in Spain of the European Medicines Agency (EMA). It is a state agency attached to the Ministry of Health, Consumer Affairs and Social Welfare, whose purpose is to ensure citizens and healthcare professionals that medicines for human and veterinary use, medical devices, cosmetics and personal care products marketed in Spain meet the strict criteria of quality, safety, efficacy, information and accessibility of current legislation (Law 29/2006, on guarantees and rational use of medicines and health products, which incorporated directives 2004/27/EC and 2004/28/EC of the European Parliament into Spanish law) from research to end use, in the interests of protecting and promoting human health, animal health and the environment.

It has its origins in the Spanish Medicines Agency (AGEMED, AEM), created in 1999 as an autonomous public body of the then called Ministry of Health and Consumption which, by Royal Decree 1275/2011, was transformed into the current state agency.

What does the AEMPS do?

These are the main activities of the AEMPS:

  • Inspection and authorization of pharmaceutical laboratories and manufacturers of active ingredients
  • Evaluation and authorization of medicinal products for human and veterinary use, after checking their quality, safety and efficacy.
  • Authorization of the conditions of use of these medicinal products and medical devices.
  • Authorization of clinical trials with medicinal products and medical devices.
  • Surveillance of adverse reactions.
  • Authorization or registration actions.
  • Continuous assessment of the benefit/risk balance of medicines on the market.
  • Fight against illegal and counterfeit medicines, medical devices and cosmetics.
  • Supervision of the supply and distribution of medicinal products.
  • State functions and responsibilities for the inspection and control of narcotic drugs and psychotropic substances.
  • Certification, control and surveillance of medical devices.
  • Monitoring the safety of cosmetics and personal care products.
  • Information on everything related to these aspects aimed at citizens and health professionals.
  • Elaboration of the regulations that facilitate the fulfillment of its functions.

 

This is possible thanks to the AEMPS human team, made up of highly qualified professionals, to the scientific committees and coordination committees specialized in the main areas of intervention and to the AEMPS Network of Experts, made up of professionals from the National Health System and Spanish universities, which provides scientific and clinical advice in specific areas of knowledge.

Medical translation and the AEMPS

The translation into Spanish of the dossiers that foreign pharmaceutical products and medical devices manufacturers have to submit to the AEMPS during the application process for registration and marketing authorization in Spain is one of the main sources of work for medical translators. These are the most frequently translated documents:

  • Resúmenes de características del producto o ficha técnica (summary of product characteristics, SmPC)
  • Prospectos de producto (product leaflets)
  • Etiquetas y embalaje (labelling and packaging)
  • Expedientes de autorización de comercialización (marketing authorization dossier)
  • Variaciones de autorización de comercialización (marketing authorization variations)
  • Informes de experto (expert´s reports)
  • Protocolos e informes de validación (validation protocols and reports)
  • Documentación del ensayo clínico (clinical trial documentation)
  • Documentación de seguridad (safety documentation)
  • Consentimiento informado (informed consent)
  • Informe anual de seguimiento del ensayo clínico (clinical trial annual progress report)

 

References

  1. Cómo se regulan los Medicamentos y Productos Sanitarios en España. 2014.

English-Spanish terminology related to regulatory affairs