The new norms decreed by the legislative dirrective 91-93 CCE
Neri, M.; Palazzo, S.
Bollettino Chimico Farmaceutico 137(2): 31-34
1998
ISSN/ISBN: 0006-6648 PMID: 9595832 Document Number: 484936
The Community law now rules any sector of the economy including the Pharmaceutical Industry, which is controlled with a special attention starting from drugs manufacturing up to marketing. After detailing the Community regulations acknowledged by the Italian legislation since the adoption of the first Pharmaceutical Directive in 1965, the Authors examine the Decree Law of february 1997 by which the EEC Directive 93/39 is acknowledged (as amended Directives EEC 65/65,75/318 and 75/319 relating to medicinal products for human use). A special attention is devoted to the several regulations concerning Pharmacovigilance, whose importance is emphasized.