European Pharmacopoeia 9th edition - English Print

The 9th Edition of the European Pharmacopoeia (EP), main volume and supplements, is legally binding and details the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, the raw materials used in the production of medicines and on the intermediates of synthesis. The EP is a single reference work for the quality control of medicines in Europe. All producers of medicines or substances for pharmaceutical use must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe. Earliest access to all European quality standards that come into effect on 1 January 2017. The European Pharmacopoeia is Europe’s legal and scientific benchmark for pharmacopoeial standards which contribute to delivering high quality medicines in Europe and beyond. It is applicable in 37 European countries and used in over 100 countries worldwide. It delivers crucial information earlier than any other pharmacopoeia – the 9th Edition will be released in mid-2016. With 121 new and 1,403 revised texts, over 50% of the 9th Edition’s content is new compared to the 8th Edition. The 9th Edition will consist of 3 initial volumes (9.0) and 8 non-cumulative supplements (9.1 to 9.8). Volumes 1, 2 and 3 combined contain 2329 monographs (including dosage forms), 358 general texts (including general monographs and methods of analysis) and around 2600 descriptions of reagents. New feature: it includes a direct link to the KNOWLEDGE database from each monograph. Mission The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are to be appropriate as a basis for the safe use of medicines by patients. In addition, their existence facilitates the free movement of medicinal products in Europe and beyond. European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of: · regulatory authorities; · those engaged in the quality control of medicinal products and their constituents; · manufacturers of medicinal products and their individual components. The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.
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An aparitie	2016
Autor	Conseil de l'Europe
Dimensiuni	21.0 x 29.7 cm
Editura	EDQM
Format	Hardback
ISBN	9789287181336
Limba	Engleza