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Background & Legal Framework

Background

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 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.

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