A Critical Analysis of the New Spanish Regulation on Inmunological Medicaments

Abstract

The Law on Medicaments warns in its article 39, of the existence of inmunological medicaments in the context of the so called “special”, adapting the Directive 89/342/CEE to the Spanish Pharmaceutical Legislation. Under this perspective, inmunological medicaments are regulated, adopting for that, the necessary measures to guarantee raw materials quality, and the necessary provisions are established for the observance of criteria on quality, reliability and efficiency of this kind of medicaments authorization, production and control. The most outstandig thing in the Royal Decree 288/91 of 8fh March, is the faculty confered to the Ministty of Health and Consumer Affairs to submit for previous authorization each lot of inmunological medicaments before they are commercialized. Therefore, this is an innovatory Royal Decree regulating correctly this special kind of medicaments and collecting all tendencies dictated by the European Community.