Format, organization, and processing of registration dossiers in the European Economic Community (EEC).

ABSTRACT

The free circulation of drugs among the European Economic Community (EEC) member states ensues from the principles stated by the Treaty of Rome. This is possible thanks to a series of legal and technical directives stating the criteria with which the national authorities--who are sovereign in this matter--must comply. These directives are briefly explained. In particular, the procedure by which the initial authorization, granted by one member state, can be extended to at least five others is presented. The content and order of the registration dossier is presented in detail.