Mohrbutter K P
Bundesinstitut für Arzneimittel und Medizinprodukte, Berlin.
Z Arztl Fortbild Qualitatssich. 1997 Nov;91(7):593-6.
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.
基于德国国内法规和欧洲法规，德国存在多种并行的授权程序。有受德国药品法管辖的国内程序，以及直接受欧盟指南和法规管辖的程序。国内程序可适用于含有新物质或已知物质的药品，而对于标准制剂、平行进口药品及所谓的旧市场产品，则必须采用国内程序。通过国内程序获得的许可仅在德国有效。分散程序也是通过颁发国内上市许可来完成的。通过伦敦药品机构（欧洲药品评价局）的集中程序的产品，不会获得个别国家的授权，而是由欧盟委员会颁发上市许可；这些许可同时对欧共体所有成员国有效。
