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Actualities of the European Pharmacopoeia in the Polish Pharmacopoeia

Ewa Leciejewicz-Ziemecka 

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

Abstract

Elaboration and publication of the Polish Pharmacopoeia are essential parts of the mission of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, i.e. “Our main priority is to ensure the proper quality, efficiency and safety of medicinal products, medical devices and biocidal products in benefit of the society’s wellbeing”.

The new, IXth edition of the Polish Pharmacopoeia, which is in full accord with the European Pharmacopoeia (Ph. Eur.), was published in November 2011. It is the first edition of the Polish Pharmacopoeia which contains Polish version of full texts of Ph. Eur. published up to now systematically in the VII and VIII editions of Polish Pharmacopoeia.

Since December 2006 Polish representatives have been taking part in the activities of the European Pharmacopoeia Commission and its groups of experts in Strasbourg. Proposals concerning the introduction or revision of monographs Ph. Eur. have been made by the Polish party.

The IXth Edition of the Polish Pharmacopoeia contains also systematically extended section of national monographs for galena products, a register of doses and A, B, N registers of active substances described in monographs.

The Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products introduced also organization changes in the activity of the Polish Pharmacopoeia Commission. In November 2011 a new Commission composed of 7 members has been established. In February 2012 eleven expert groups have been called up. Their activity is coordinated by the Pharmacopoeia Department.

The publication system of the European Pharmacopoeia requires constant updating of the Polish Pharmacopoeia. Therefore, in 2012, the Supplement 2012 based on the Supplements 7.3 – 7.5 Ph. Eur. will be published. It will also contain successive national monographs.

 

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Related papers

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

Submitted: 2012-03-12 08:17
Revised:   2012-03-12 08:17