Witold Wieniawski

Jednolity rynek leków w Europie - następny krok do jego urzeczywistnienia

Unified European drug market - next step towards its achievement. Important modifications in European Union directives related to drug registration, which came into force in November 2005, and their forthcoming implementation are discussed. The importance of the mutual recognition procedure and of its modified version - the decentralized procedure - is stressed. New aspects of the centralized procedure are described and a marked influence of national drug regulatory authorities in the registration process analyzed.