European Pharmacopoeia - Background and Mission
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 Directive 2001/83/EC as amended, on medicines for human use and and Regulation (EU) 2019/6 on veterinary medicinal products. 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 purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are to be appropriate as a basis for the safe use of medicines by patients. In addition, their existence facilitates the free movement of medicinal products in Europe and beyond.
European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:
- regulatory authorities;
- those engaged in the quality control of medicinal products and their constituents;
- manufacturers of medicinal products and their individual components.
The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.
- 174th Session: 22-23 November 2022
- Convention on the Elaboration of a European Pharmacopoeia (ETS No. 50), 1964
- Protocol to the Convention on the Elaboration of a European Pharmacopoeia (ETS No. 134), 1989
- Guide for the Work of the European Pharmacopoeia
- Rules of Procedure of the European Pharmacopoeia Commission
- Code of Practice for the work of the European Pharmacopoeia