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The European Pharmacopoeia in the Polish Pharmacopoeia

Ewa Leciejewicz-Ziemecka 

Urzad Rejestracji PLWMiPB, Zabkowska 41, Warszawa 03-736, Poland

Abstract

Correct quality of medicinal products is connected with full filing all the criteria of quality of: identification, purity, content of active substance and functionality which are included in suitable documents, e.g. in pharmacopoeial monographs. General and individual monographs compose the Pharmacopoeia, however the national and international legislation makes them obligatory standards at a given territory.

The European Pharmacopoeia is obligatory in member states of Convention on the Elaboration of a European Pharmacopoeia replacing any national monograph on the same subject. The Polish version of European Pharmacopoeia is published as Polish Pharmacopoeia VII/VIII edition by The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The implementation of European Pharmacopoeia requirements into Polish Pharmacopoeia changes existing rules of Polish Pharmacopoeia applications.

 

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Related papers

Presentation: Poster at VII Multidyscyplinarna Konferencja Nauki o Leku, by Ewa Leciejewicz-Ziemecka
See On-line Journal of VII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2010-02-17 13:17
Revised:   2010-02-17 13:17