title: [National and European drug approval procedures].
abstract: On the basis of national and European regulations, different authorization procedures exist side by side in Germany. There are the national procedures governed by the German drug law, and those directly governed by the guidelines and regulations of the European Union. National procedures can be applied to drugs with new or with known substances while they are obligatory in the case of standard preparations, parallel imports and the so-called old market products. Licensing under a national procedure is valid exclusively in Germany. Also the decentralised procedure is completed by issuance of a national marketing license. Products passing through the centralised procedure of the London drug agency (EMEA) are not granted individual national authorizations but European Commission issued marketing authorizations; these are simultaneously valid for all members States of the European Communities.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Berlin.
authors.forename: K P
authors.initials: KP
authors.lastname: Mohrbutter
mesh_terms: D003431:Cross-Cultural Comparison; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D005858:Germany; D006801:Humans
vernacular_title: Nationale und europäische Zulassungsverfahren.