Alims ALiMS Vlada Republike Srbije
ALiMS
Pharmacopoeia
EDQM, EP COMMISSION, OMCL NETWORK

Striving to achieve a higher degree of unity and progress in social domain and public health domain, Member States of the European Council decided on the necessity of joint actions and the conclusion of an agreement which would be of general interest for the people of Europe.

In order to accelerate the draw up of specifications for an increasing number of medical substances and the adjustment of specifications for the existing medical substances and pharmaceutical forms, and in order to take appropriate measures regarding the manufacture and marketing of medicinal products in Europe, Member States determined that this goal may be best achieved by establishing and continually improving joint pharmacopoeia under the name of the European Pharmacopoeia, with the monographs that would become official standards in those states.

In 1964 in Rome the Convention on compilation of the European Pharmacopoeia was adopted, according to which the following entities would elaborate the European Pharmacopoeia:

  • Public Health Committee, carrying out activities within the European Council.
  • European Pharmacopoeia Commission, established by The Public Health Committee.
  • European Directorate for the Quality of Medicines, EDQM, established in 1996 as a The European Directorate.
The European Directorate for the Quality of Medicines is responsible for:
  • The Technical Secretariat of the European Pharmacopoeia Commission
  • Publications and distribution of the European Pharmacopoeia
  • Preparation and distribution of Chemical Reference Substances, CRS and Biological Reference Preparations, BRP
  • Certification of suitability of European Pharmacopoeia monographs
  • Official Medicines Control Laboratories, OMCL