individual texts describing legally-binding quality standards for finished products.

individual texts describing legally-binding quality standards for substances used in the manufacture of medicines or medicine ingredients (including active pharmaceutical ingredients, excipients, herbals, etc.).

Nowadays it contains over 3000 texts (the monographs), covering all therapeutic areas and consisting of: is applicable in 39 European countries and used in over 100 countries worldwide. The 10th edition, currently applicable, was published in July 2019.

The first edition of the European Pharmacopoeia was published in 1969, and consisted of 120 texts. Arvidsson's term for Chair is three years, and runs in parallel with other members of the Commission's Presidium. TorbjГ¶rn Arvidsson, who was elected in March 2019. The current Chair of the Commission is Prof. Representatives of the thirty (30) observers are invited to attend the sessions, but cannot vote. Member states' representatives mostly come from health authorities, national pharmacopoeia authorities and universities and are appointed by the national authorities on the basis of their expertise. In all technical questions, the decisions of the Commission are taken by a unanimous vote of the national delegations that cast a vote. Items are added to the work programme in response to requests received by the European Directorate for the Quality of Medicines & HealthCare from the member states and their national authorities, industry or experts from around the world, based on current scientific and health issues. This Commission meets in Strasbourg, France, three times a year, to adopt texts proposed by its groups of experts, and to decide on its programme of work and general policies. It also decides the work programme, sets up and appoints experts to the specialised groups responsible for preparing monographs, adopts these monographs, and recommends dates for the implementation of its decisions within the territories of the contracting parties.

The European Pharmacopoeia Commission determines the general principles applicable to the elaboration of the European Pharmacopoeia. While the European Directorate for the Quality of Medicines & HealthCare (EDQM), a directorate of the Council of Europe, provides scientific and administrative support for the European Pharmacopoeia, the governing body is the European Pharmacopoeia Commission. There are 30 observers in all: five European countries, 23 non-European countries, the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. ДЄs of February 2020, thirty-nine (39) member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to be able to market and use these products in Europe. 134) was adopted, amending the convention to prepare for the accession of the European Union (EU), and defining the respective powers of the European Union and its member states within the European Pharmacopoeia Commission.Д®uropean Union Directive 2001/82/EC and Directive 2001/83/EC, (as amended) state the legally binding character of European Pharmacopoeia texts for Marketing Authorisation Applications (MAA). 50) which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the European Pharmacopoeia. The Convention on the Elaboration of a European Pharmacopoeia (ETS No. Several legal texts make the European Pharmacopoeia mandatory in Europe. The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) signatory states, which include all European Union member states. It is used as an official reference to serve public health, and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product. The European Pharmacopoeia has a legally binding character. 2 The European Pharmacopoeia Commission.

European pharmacopoeia free