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[Generics: authorization to market and quality guarantees].

作者信息

De Muylder J A

出版信息

Rev Med Brux. 2000 Sep;21(4):A276-8.

Abstract

The act of July 3, 1969, concerning the registration of drugs includes the European Directive, more specifically for the generic, the definition using three axes of comparison as essentially similar to the original registered drug. This definition invites comments, e.g. on the pharmaceutical and therapeutic quality of the generic drug. The promotion of generics in Europe necessarily implies a better quality control that would give the generic an identical label as the reference drug.

摘要

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