On 17 December 2012, the Permanent Representation of Ukraine to the Council of Europe handed to Mr Thorbjørn Jagland, Secretary General of the Council of Europe, its instrument of accession to the European Convention on the Elaboration of a European Pharmacopoeia [European Treaty Series n° 050], as amended by the Protocol of 16 November 1989. This text will enter into force in Ukraine on 18 March 2013. Ukraine is the 38th member of the European Pharmacopoeia.
Ratification of this Convention marks the desire of the Ukrainian authorities to participate in the development of European standards for the quality of medicines and to strengthen their collaboration with European countries in the field of medicines and healthcare, with the objective to share knowledge and expertise in order to better serve public health. It also shows the importance of the work of the European Pharmacopoeia Commission at international level.
The Convention, adopted by the Council of Europe in 1964, has the objective of progressively elaborating a pharmacopoeia in Europe that is common to all the member states and which defines a single set of specifications and test methods that will become the official standards applicable within these countries for active substances and excipients used in medicines.
The European Pharmacopoeia is a collection of quality standards (also named “monographs”) applicable to all medicines. Tests to be carried out on medicines and raw materials used in the production of medicines are described in details. These quality standards are legally binding and compliance is mandatory in order to obtain a marketing authorisation from a national or European authority. They cover a wide range of active substances and excipients used to prepare medicines and include general texts on biological substances, herbal drugs, antibiotics, vaccines as well as dosage forms and containers.
The European Pharmacopoeia thus ensures the quality of medicines and facilitates their free movement in Europe and beyond.