title: [The new norms decreed by the legislative dirrective 91-93 CCE].
abstract: 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.
authors.affiliation: Dipartimento di Chimica e Tecnologie Farmaceutiche, Univeristà degli Studi di Palermo.
authors.forename: M
authors.initials: M
authors.lastname: Neri
authors.forename: S
authors.initials: S
authors.lastname: Palazzo
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence*; D006801:Humans; D007558:Italy; D007880:Legislation, Drug / Q000639:trends*; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing
chemical_list: D004364:Pharmaceutical Preparations
vernacular_title: Le nuove norme dettate dal decreto legislativo che attua la direttiva 93/39 CEE.