Members for the Medicinal Products Committee
Tasks of the Medicinal Products Committee
The Danish Medicines Agency can seek advice from the Medicinal Products Committee in specific cases related to the assessment of human and veterinary medicines.
In practice, the Medicinal Products Committee advises the Danish Medicines Agency in matters regarding:
- the application for, variation to and withdrawal of marketing authorisations for medicinal products
- the monitoring of adverse reactions and other risks involving medicinal products
- the evaluation of the risk-benefit balance of medicinal products
- clinical trials of medicines.
Problems of a more general nature are also expected to be referred to the Committee.
The Minister for Health may assign new tasks to the Committee.
The Committee is established pursuant to sections 96 and 98 of the Danish Medicines Act.
Members and qualifications
The Medicinal Products Committee consists of no more than 15 members of which two must represent patient and consumer interests. The members are appointed by the Danish Minister for Health upon nomination by the Danish Medicines Agency.
The members of the Medicinal Products Committee must have a wide expertise in either internal medicine or veterinary medicine as well as pharmaceutical expertise regarding the production of medicinal products. We would also like to see members with knowledge of and experience with daily clinical contact. We are also looking for candidates with specific expertise in medicinal product safety including pharmacoepidemiology. The members representing patient and consumer interests are expected to have a general knowledge of medicinal products.
The members are appointed based on their personal skills. The members with specific expertise are appointed based on their background as well as their proven scientific experience in and knowledge of the regulatory processes related to the licensing and monitoring of medicinal products.
The members are not allowed to have any financial or other interests in the pharmaceutical industry that are likely to affect their impartiality, cf. section 102(1) of the Danish Medicines Act.
Chair, secretariat and meetings
The Minister for Health appoints a chair and a vice-chair from among the members of the Medicinal Products Committee.
The Danish Medicines Agency serves as secretariat for the Medicinal Products Committee. The Committee meets six to ten times a year. The meetings are held either as virtual meetings or in the Danish Medicines Agency’s offices at Islands Brygge in Copenhagen.
Submission of nominees
The names of nominees are to be submitted to the Danish Medicines Agency by 30 June 2021 at noon.
The application is to be sent to Maria Bruun via email
or to our address:
Danish Medicines Agency
Axel Heides Gade 1
2300 Copenhagen S
Denmark
Please mark the application ‘Medicinal Products Committee’ and enclose a CV.
Please indicate any conflicts of interest and refrain from including personal data in the application.
Further information
The rules regulating the activities of the Medicinal Products Committee are laid down in the executive order on the rules of procedure of the Medicinal Products Committee (no. 1214 of 1 October 2013).
Members are remunerated according to the Danish Employee and Competence Agency’s circular on remuneration of members of collegiate bodies in the state.
For more information about the work of the Committee, please contact:
Director Hanne Lomholt Larsen via email
Phone number of the Danish Medicines Agency: +45 4488 9595
Lines are open Monday to Friday from 10:00 to 15:00.