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The European Pharmacopoeia represents the most up-to-date and complete compilation of quality standards for all medicinal products on the market in Europe. It is an essential tool for those involved in pharmacovigilance and is recognised as such by the World Health Organization (WHO). It also provides a reference document for those concerned with international trade, as many countries now require products they import to meet pharmaceutical quality standards equivalent to those found in the European Pharmacopoeia. Download this free PDF to explore new and improved guidelines and learn more about how EU Member States manage their medicines (including legislation on labelling, ingredients, storage conditions). This version has been published in January 2018, by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Download Full Text: Click Here

The European Pharmacopoeia is a collection of documents which set out national and international standards and other information on the identity, purity and quality of active substances and excipients used in the manufacture of medicinal products. The European Pharmacopoeia is recognised by the World Health Organization (WHO) and is based on international general principles formulated by experts in pharmacopoeial standardisation. It provides harmonised standards for medicinal products throughout Europe. It is recognised as a reference document by the European Commission, the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), Codex Alimentarius and other regulatory authorities. The WHO Expert Committee on Specifications for Pharmaceutical Preparations uses information from the European Pharmacopoeia as a reference document. In addition, a growing number of countries require that pharmaceutical products they import meet pharmaceutical quality standards equivalent to those found in the European Pharmacopoeia. The WHO has highlighted these documents as an essential tool for those involved in pharmacovigilance. They contain valuable information on both active substances and excipients, which is used as a reference source by regulatory authorities worldwide for medicinal products. The European Pharmacopoeia is an essential source for human medicines. It offers harmonised standards for active substances and excipients, which are based on international general principles formulated by experts in pharmacopoeial standardisation. The European Pharmacopoeia is recognised as a reference document by the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), Codex Alimentarius and other regulatory authorities. The current European Pharmacopoeia comprises 23 pharmacopoeias with supplements, which are organised into four volumes, each of which is divided into chapters. Each chapter contains the most recent version of the European pharmacopoeias with supplements covering a single field of activity e.g. Aids, Antibiotics, Anesthetics, Antidiarrhoeal Agents, Anti-infectives. The current European Pharmacopoeia is divided into chapters on the following fields of activity: Volumes are organised into three main groups: Each group contains several additional chapters covering special requirements with respect to the product in that group. These are called "Group with supplements" in the European Pharmacopoeia for human medicines The four different groups are applied to all medicinal products in full or in part according to Chapter 2.2 of Volume 1(V1) and consolidated within this document with an overview on each of them.

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