Medicines registration in Europe: role of the Regulatory Agencies

Mariano Madurga Sanz^a, FJ de Abajo Iglesias^b, D Montero Corominas, G Martín-Serrano García

^aFarmacéutico y Farmacoepidemiólogo. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Ministerio de Sanidad y Consumo. Madrid. España.
^bAgencia Española de Medicamentos y Productos Sanitarios. Ministerio de Sanidad y Política Social.

Correspondence: M Madurga. E-mail: mmadurga@agemed.es

Reference of this article: Madurga Sanz M, de Abajo Iglesias FJ, Montero Corominas D, Martín-Serrano García G. Medicines registration in Europe: role of the Regulatory Agencies. Rev Pediatr Aten Primaria. 2004;6:323-343.

Published in Internet: 30-06-2004 - Visits: 8565

Abstract

In the last years, the National Regulatory Authorities of the European Union were reorganized, especially in Spain. This paper describes the functions and characteristics of the Spanish Medicines Agency. We review the European current procedures of medicines? registration. Particularly, we describe the data, which should be necessary to register medicinal products. Also, we review the drug information for prescribing, dispensing, and for its administration. The European Commission, and the European Agency for the Evaluation on Medicinal Products (EMEA) have taken several initiatives to optimize the paediatric use of medicines, and reduce the use of unlicensed and off-label medicine in children.

Keywords

● European Agency for the Evaluation of Medicinal Products (EMEA) ● Medicines in Children ● Pharmaceutical regulation ● Spanish Medicines Agency

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