[A critical analysis of the new Spanish regulation on immunological medications].

Abstract

The Law on Medicaments warns in its article 39, of the existence of immunological medicaments in the context of the so called "special", adapting the Directive 89/342/CEE to the Spanish Pharmaceutical Legislation. Under this perspective, immunological 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 outstanding thing in the Royal Decree 288/91 of 8th March, is the faculty conferred to the Ministry of Health and Consumer Affairs to submit for previous authorization each lot of immunological 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.