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The EDQM is a Directorate of the Council of Europe (Directorate General of Democracy (DGII)). It is headed by a Director and consists of four Departments, four Divisions and one Unit.

Departments of the EDQM

The European Pharmacopoeia Department (EPD) is responsible for the Secretariat of the European Pharmacopoeia Commission and for preparing the General Chapters and Monographs of the European Pharmacopoeia with the groups of experts. It also ensures the translation of the European Pharmacopoeia into both official languages of the Council of Europe: English and French and the translation of EDQM texts, covering a wide range of subjects related to pharmaceutical sciences and technology.

The Publications and Multimedia Department (DPM) is responsible for the production of EDQM publications, both printed and electronic versions, and for the development and maintenance of our databases. The DPM also provides internal IT support.

The Laboratory Department (DLab) contributes to the European Pharmacopoeia by providing analytical studies to develop its texts (General Chapters and Monographs,) and by establishing the corresponding reference standards. It is also involved in the establishment of WHO International Standards for Antibiotics (ISA) and International Chemical Reference Standards (ICRS). Finally, it contributes to the development of Proficiency Testing Scheme (PTS) studies for the General European OMCL Network and the World Health Organization (WHO).

The Biological Standardisation, Network of Official Medicines Control Laboratories (OMCL) and HealthCare Department (DBO) is responsible for the Biological Standardisation Programme (BSP), the Secretariat of the General European OMCL Network (GEON) and the Secretariat of the Steering Committees on Blood Transfusion (CD-P-TS) and Organ Transplantation (CD-P-TO). The DBO is also responsible for the Secretariat of the Steering Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the Secretariat of the Consumer Health Protection Committee (CD-P-SC) and their subordinate bodies.

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Divisions of the EDQM

The Certification of Substances Division (DCEP) is responsible for implementing the procedure for Certification of Suitability of the monographs of the European Pharmacopoeia (CEPs). The DCEP is also responsible for the organisation of onsite inspections of manufacturing sites and their follow-up, including the implementation of any subsequent action regarding the related CEPs and communication with the concerned authorities.

The Reference Standards and Samples Division (DRS) is responsible for the production, storage and dispatch of the European Pharmacopoeia Reference Standards, WHO International Standards for Antibiotics (ISA) and International Chemical Reference Standards (ICRS). It also procures samples, which are analysed in the process of elaborating the European Pharmacopoeia Monographs.

The Public Relations and Documentation Division (PRDD) is responsible for the EDQM's communications with its stakeholders, the general public, the media etc. It supplies information on, and answers questions about, the EDQM's activities. This includes maintenance of the website and production of EDQM catalogues, brochures and other public relations literature. The PRDD also organises EDQM events and ensures its participation in trade fairs and seminars. Finally, it is responsible for managing the archives and the EDQM library.

The Administration and Finance Division (DAF) is responsible for the administrative and financial management of the EDQM, which includes preparing and monitoring the budget, validating financial transactions and recruiting and developing staff and seconded personnel. These activities are carried out in close collaboration with the Council of Europe's Directorate General of Administration and Logistics (DLOG). The DAF is also responsible for processing customers' orders for EDQM products, issuing invoices and dealing with related queries.

Units of the EDQM

The Quality, Safety & Environment Unit (QSEU) coordinates the development and maintenance of the EDQM's quality, safety and environmental management systems, which aims to continuously improve EDQM products and services. The QSEU is also responsible for the release of reference standards and samples produced at the EDQM. It carries out regulatory and normative surveillance activities to ensure that its operations comply with international, regional and local requirements in force and provides support for management of the building.