The Medicines Evaluation Board (MEB) is an independent administrative body within central government, which falls under the responsibility of the Ministry of Health, Welfare and Sport. The Board is responsible for medicine marketing authorisations in accordance with the Medicines Act. We assess the balance between the efficacy and the adverse reactions and risks of medicines. We also examine whether the quality of the medicine is satisfactory and remains so. In the event of a positive opinion, the MEB authorises the medicine for the Dutch (and/or European) market.
The members of the Board are supported by the Agency (aCBG). The Agency is responsible for preparing and implementing decisions of the Board. The Board issues an independent and expert opinion on the basis of that preparatory assessment. An opinion by the Board may, for example, relate to new marketing authorisations for medicines, the amendment, suspension or withdrawal of these marketing authorisations, but also pharmacovigilance and patient information leaflets.
We frequently carry out our tasks on the basis of collaboration in the Netherlands and with other national authorities in Europe.
The MEB takes decisions regarding the authorisation of medicines on the Dutch market. The Board has a maximum of 17 members, including the chair. The members are medical specialists, hospital pharmacists, professors and other experts. They are leading experts in the medicine or pharmaceutical field who fulfil their role of Board member alongside their day jobs.
Members of the Board are appointed by the Minister for Health, Welfare and Sport for a period of 4 years, after which they may be reappointed. The composition of the Board is always based on an assessment of what is necessary in order to represent the practical situation as effectively as possible.
A meeting attended by all Board members currently takes place once a month, while another monthly meeting is attended by a smaller group of members. The chair and vice-chair also meet every week to discuss specific questions about the medicine dossier. During these meetings decisions are taken regarding the awarding of new marketing authorisations for medicines and the amending of existing marketing authorisations.
The Agency employees use the meetings to discuss the medicine dossiers they have assessed, as part of the assessment process. After that, the MEB takes a decision on the awarding, amending, suspension or withdrawal of marketing authorisations. We always base such decisions on signals of important new risks and adverse reactions, current affairs in the field of medicines, pharmacovigilance, policy, scientific research, experiences and agreements in practice.
Agenda, public report and other information
We publish the agenda and a public report of each Board meeting. The report describes the recommendations made, positions adopted and decisions taken during the meeting. As long as no definitive decision has been taken on a case, or an opinion published by the Committee for the Assessment of Medicinal Products for Human Use (CHMP), the relevant passages in the public Board report will remain confidential. After the conclusion of a procedure or case, the previously adopted passages are added to the public report. The marketing authorisation, patient information leaflet and the summary of the product characteristics of a medicine are also public and can be found in the MEB Medicines Information Bank. You can read other reports as well, which are also referred to as Public Assessment Reports (PARs).