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.
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