title: [Review of the development in European Legislation on the harmonisation of the laws for medicinal products].
abstract: The harmonisation of the legislation for medicinal products is an on-going process even after 40 years of development. The first step for harmonising the requirements for the marketing authorisation and monitoring took place with the introduction of the first pharmaceutical directive in 1965. Further components of European legislation such as directives, which have to be transposed into national law by the Member States, and regulations, which take effect immediately, have been adopted since then. The latest fundamental progress made in the process of harmonising the European market for medicinal products was the adoption of Directive 2004/27/EG in the framework of the Pharma-Review 2002. In addition to the existing centralised procedure and mutual recognition procedure a decentralised procedure and the enlargement of the area of authority of the European Medicines Agency were introduced. Lately new laws for medicinal products for children and advanced therapies were introduced through a regulation.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, Bonn, BRD. blehmann@bfarm.de
authors.forename: Birka
authors.initials: B
authors.lastname: Lehmann
mesh_terms: D003299:Cooperative Behavior; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D005062:European Union / Q000458:organization & administration*; D007373:Interinstitutional Relations; D007880:Legislation, Drug; D040541:Marketing / Q000331:legislation & jurisprudence*; D004364:Pharmaceutical Preparations
chemical_list: D004364:Pharmaceutical Preparations