Witold Wieniawski

Kontrola leków w Unii Europejskiej - zmiany w ustawodawstwie i pierwsze rezultaty. Część I. Systemy rejestracji leków

Control of medicines in the European Union - recent legislative changes and early results. Part 1. Registration and control systems. Recent modifications in the pharmaceutical law of the European Union (EU) and their influence on the activities of various drug regulatory bodies are discussed. The coexistence on EU market of pharmaceutical products licensed under the EU centralized procedure and those licensed by national authorities, including products licensed under the mutual recognition and decentralized procedures, is described and the consequences for drug control activities are stressed.