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.

Legal Framework

Several legal texts make the European Pharmacopoeia mandatory. These are as follows:

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.