European Pharmacopoeia 7.0 volume 1

European Pharmacopoeia 7.0 volume 1 - Praca Zbiorowa

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.European 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). 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.As of November 2016, thirty-seven (37) member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. Twenty-six (26) countries from all continents are part of its observers, as is the World Health Organization (WHO) and the Taiwan Food and Drug Administration.