El pleno del Parlamento Europeo aprobó por amplia mayoría un informe de la diputada socialista alemana Rosemarie Mueller para reforzar el mecanismo centralizado a la hora de autorizar medicamentos con nuevas sustancias activas a través de la Agencia Europea del Medicamento (EMEA).
No obstante, se mantiene el procedimiento descentralizado con el que se permite que un medicamento aprobado por un Estado miembro se pueda comercializar en otro, gracias al reconocimiento mutuo, añadiéndose la novedad de que los medicamentos con sustancias activas nuevas sólo podrán ser autorizados de forma descentralizada.
No obstante, el Parlamente Europeo aboga por una excepción para las pequeñas y medianas empresas, que podrán elegir entre ambos procedimientos para reducir sus costes. Asimismo, exige una reducción de las tasas para las solicitudes presentadas por pequeñas y medianas empresas.
La Eurocámara aprobó tres propuestas legislativas en primera lectura sobre la legislación europea de medicamentos, que abordan el procedimiento de autorización de medicamentos, el código comunitario sobre fármacos para uso humano y el código para los medicamentos veterinarios.
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