CouncilEurope

Convention on the Elaboration of a European Pharmacopoeia

(ETS No. 050)

Open for signature by the signatory governments, in Strasbourg, on 22 July 1964.

Entry into force: 8 May 1974.

Summary of the treaty

The Convention aims to harmonise specifications for medicinal substances in their original state or in the form of pharmaceutical preparations. The Parties undertake progressively to elaborate a European pharmacopoeia. The European Pharmacopoeia becomes the official standard applicable within the respective Parties. It is drawn up by the European Pharmacopoeia Commission which determines the general principles applicable to the elaboration of the European Pharmacopoeia, decides upon methods of analysis, arranges for the preparation of and adoption of monographs to be included in it, and recommends the fixing of the time limits within which its decisions of a technical character are to be implemented within the territories of the Parties.

The European Pharmacopoeia Commission operates under the overall supervision of the Public Health Committee.

The Protocol (ETS No. 134), opened for signature by the member States of the Council of Europe having signed or acceded to the Convention, in Strasbourg, on 16 November 1989, and entered into force on 1 November 1992, provides for the accession of the European Union to the Convention, and sets out the modalities of its participation in the European Pharmacopoeia Commission.