European Pharmacopoeia

The European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which 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.

The European Pharmacopoeia 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 (human or veterinary) product. Pharmacopoeia Europaea quality standards apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-eight (38) signatory states and the European Union member states.

Several legal texts make the European Pharmacopoeia mandatory in Europe. The Convention on the Elaboration of a European Pharmacopoeia (CETS 50) which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the European Pharmacopoeia. In 1994, a Protocol (ETS No. 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.

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