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The European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) is a pharmacopoeia that aims to provide common quality standards throughout Europe to control the quality of medicines and the substances used to manufacture them. It is a published collection of monographs that describe both the individual and general quality standards for ingredients, dosage forms and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use. == Legal basis == The Ph. Eur. has a legally binding character. It is used as an official reference to serve public health and is part of the regulatory requirements for obtaining a Marketing Authorisation Application (MAA) for a medicinal product. Ph. Eur. quality standards apply throughout the entire life-cycle of a product and become legally binding and mandatory on the same date in all 37 signatory states and the European Union member states. Several legal texts make the Ph. Eur. mandatory in Europe. The Convention on the Elaboration of a European Pharmacopoeia (CETS 50) 〔(“Convention on the Elaboration of a European Pharmacopoeia CETS No.: 050, Treaty Office, Council of Europe” )〕 which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the Ph. Eur. In 1994, a Protocol (ETS No. 134) 〔(“Protocol 1994” )〕 was adopted amending the Convention to prepare for the accession of the European Union and defining the respective powers of the European Union and its Member States within the Ph. Eur. Commission. European Union directives (2001/82/EC 〔(“2001/82/EC” )〕 and 2001/83/EC,〔(“2001/83/EC” )〕 as amended, and 2003/63/EC 〔(“2003/63/EC” )〕) state the legally binding character of Ph. Eur. texts for Marketing Authorisation Applications (MAA). All manufacturers of medicines or substances for pharmaceutical use therefore must apply the Ph. Eur. quality standards in order to be able to market and use these products in Europe. As of December 2012, 37 member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. Twenty-six countries from all continents are part of its observers, as is the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「European Pharmacopoeia」の詳細全文を読む スポンサード リンク
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