Homepage / The European Pharmacopoeia / European Pharmacopoeia / Legal Status & Background
Goals
The European Pharmacopoeia is a single reference work for the quality control of medicines in Europe. Several legal texts make the European Pharmacopoeia mandatory:
- a Convention elaborated by the Council of Europe on the Elaboration of a European Pharmacopoeia;
Contracting parties undertake:
- Progressively elaborate a Pharmacopoeia which shall become common to the countries concerned and which shall be entitled “European Pharmacopoeia”
- Take the necessary measures to ensure that the monographs or European standards… shall become at national level the official standards applicable within their respective countries by: Direct implementation in the national legislation or indirect implementation through national translation. In case of doubt the official reference is the European Pharmacopoeia official publication rather than a national pharmacopoeia publication.
- A protocol to amend the Convention was adopted in 1994 to prepare for the accession of the European Union and define the respective powers of the European Union and its member states in the European Pharmacopoeia Commission.
- European Union directives 2001/82/EC, 2001/83/EC and 2003/63/EC (amended), on medicines for human and for veterinary use, maintain the mandatory character of European Pharmacopoeia specifications on medicines for marketing authorisation (MA) applications. These specifications concern the qualitative and quantitative composition and the tests to be carried out on these medicines, the raw materials used in production and the intermediates of synthesis. All producers of medicines or substances for pharmaceutical use therefore must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe.
1964 PhEur Convention (English)
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