![]() ![]() 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-eight (38) 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. These standards apply to medicines for both human and veterinary use. ![]() 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. ![]() 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. The European Pharmacopoeia ( Pharmacopoeia Europaea, Ph. ( November 2016) ( Learn how and when to remove this template message)Ĭover of the European Pharmacopoeia, 10th Edition Please improve this by adding secondary or tertiary sources. ![]() This article relies too much on references to primary sources. ![]()
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