The European Pharmacopoeia is a single reference work for the quality control of medicines in the signatory states of the Convention on its elaboration.
The official standards published within provide a legal and scientific basis for quality control during the development, production and marketing processes.
They concern the qualitative and quantitative composition and the tests to be carried out on medicines, on the raw materials used in production of medicines and on the intermediates of synthesis. All producers of medicines and/or substances for pharmaceutical use must therefore apply these quality standards in order to market their products in the signatory states of the Convention.
Several legal texts make the European Pharmacopoeia mandatory. These are as follows:
the Convention developed by the Council of Europe on the Elaboration of a European Pharmacopoeia,
a Protocol adopted in 1994 and amending the Convention to prepare for the accession of the European Union and defining the respective powers of the European Union and its member states within the European Pharmacopoeia Commission,
European Union Directives 2001/82/EC, 2001/83/EC, and 2003/63/EC, as amended, on medicines for human and veterinary use. These maintain the mandatory character of European Pharmacopoeia monographs when requesting marketing authorisation (MA).
The contracting parties of the Convention undertake to:
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 shall become the official standards applicable within their country by direct implementation in the national legislation or by indirect implementation through national translation.
For information about the working procedure and the functions of the different bodies responsible for carrying out the work of elaborating a European Pharmacopoeia, please consult the documents in the right-hand menu.
The mission of the European Pharmacopoeia is to:
promote public health by the provision of recognised common standards for use by healthcare professionals and others concerned with the quality of medicines,
facilitate the free movement of medicinal products in Europe,
ensure the quality of medicinal products and their components imported into or exported from Europe,
design European Pharmacopoeia monographs and other texts to be appropriate to the needs of regulatory authorities, those engaged in the quality control of medicinal products and their constituents and to the manufacturers of starting materials and their products.
149th Session, 17-18 June 2014
150th Session, 25-26 November 2014
Convention on the Elaboration of a European Pharmacopoeia, European Treaty Series (ETS), No. 50, 1964
Protocol to the Convention on the Elaboration of a European Pharmacopoeia, European Treaty Series (ETS), No. 134, December Edition, 1989
Guide for the Work of the European Pharmacopoeia (PA/PH/SG (11) 54 DEF)
Rules of Procedure of the European Pharmacopoeia Commission (PA/PH/SG (11) 53 DEF)
Code of Practice for the work of the European Pharmacopoeia (PA/PH/Exp. ROP/T (11) 8 DEF)
List of Groups of Experts & Working Parties (June 2013)