The European Pharmacopoeia is a unique reference text on quality control of medicines in signatory countries to the Convention on its development.
The Convention, established by the Council of Europe, and opened for signature in Strasbourg on July 22, 1964, has been amended in accordance with the provisions of the Protocol entered into force on 1st November 1992.
Official standards published in the European Pharmacopoeia are deemed to provide a legal basis for the scientific quality control during the process of development, production and marketing of drugs.
They concern the qualitative and quantitative composition and tests to be performed on medicines, raw materials used in manufacturing drugs and intermediate products. All manufacturers of medications and/or substances for pharmaceutical use must apply these quality standards to market their products in signatory Countries to the Convention.
The mission of the European Pharmacopoeia is to:
participate in the promotion of public health, by creating common standards accepted by health professionals and, more generally, by all those involved in drug quality;
facilitate the free movement of medicines in Europe;
ensure the quality of medicines and of their components which are imported or exported from Europe;
develop monographs and other texts of the European Pharmacopoeia to meet the requirements of regulatory authorities, of services responsible for monitoring quality of medicines and their components and of producers of raw materials and medicines.
Currently, there are 37 participating Member States, besides the European Union, while 26 states (including 18 non-members of the Council of Europe), the Taiwan Food and Drug Administration and WHO have observer status.