European Pharmacopoeia, 4th edition

 

The European Pharmacopoeia is a single reference work for the quality control of medicines in Europe. Several legal texts make the European Pharmacopoeia mandatory:A Convention on the Elaboration of a European Pharmacopoeia ratified in 2003 by 31 European countries and the European Union; European Union directives 2001/83/EC and 2001/82/EC,on medicines for human use and for veterinary use, respectively, maintain the mandatory character of European Pharmacopoeia specifications on medicines as regards their qualitative and quantitative composition and the tests to be carried out on these medicines, the raw materials used in production and the intermediates of synthesis. All producers of medicines or substances for pharmaceutical use therefore must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe. The texts of the European Pharmacopoeia are legally binding and compliance is enforced by the administrative or juridical authorities. The national authorities of the member states are bound to apply them if necessary replacing any national monograph on the same subject.

The 4th Edition consists of an initial volume 2002 (4.0) and a collection of 8 non-cumulative supplements (4.1) published three times a year following the decisions of each session of the European Pharmacopoeia Commission. With supplement 4.6, the 4th Edition comprises 1750 specific monographs, 285 general methods illustrated by figures or chromatograms and 2140 reagents. Every 4 months a new volume enters into force.

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