title: [Revision of the European pharmaceutical legislation].
abstract: In accordance with the Regulation N 2309/93/EC, the Commission shall produce a synopsis of European registration operating procedures no later than 2001. On July 18, 2001, after a wide open consultation, the College of Commissioners adopted a Proposed Revision elaborated by the "DG Enterprises". This Proposed Revision was guided by the desire to facilitate access of citizens of the European Union to innovating and safe medications, to limit fragmentation of the interior market, prejudicial to the community pharmaceutical industry, and to prepare widening of the community. This synopsis focused essentially on registration procedures and pharmacovigilance, on patient information, on reform of the European agency for administrative protection of recorded data. The Proposed Revision is following the codecision procedure and should come into force, in a more or less amended form, at the end of 2004 at the latest.
authors.forename: G
authors.initials: G
authors.lastname: Sitbon
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence; D011307:Drug Prescriptions; D005060:Europe; D007880:Legislation, Drug / Q000639:trends*; D011358:Product Surveillance, Postmarketing