The Medicines Evaluation Board Agency (MEB) is responsible for preparing and implementing decisions by the Board and for pharmacovigilance in the Netherlands. It falls under the Ministry of Health, Welfare and Sport (VWS). The organisation has more than 350 employees, of which many have a medical or pharmaceutical background. Their daily task is to assess, monitor and encourage the proper use of medicines.
In total the Agency deals with approximately 20,000 cases per year. These cases range from administrative amendments to large-scale cases such as a medicine dossier with a new active substance. Depending on the case, it is discussed by the Board, with the chair, or is processed by an authorised signatory.
The Board is supported by the Agency, which covers the primary process, support units and various programmes. The units within the primary process are responsible for assessing and monitoring medicines, each based on their own expertise. The primary process is supported by the support units and programmes. Our work also extends beyond the limits of our own organisation. For example, at various levels we cooperate with fellow authorities, healthcare providers and patients, in the Netherlands and elsewhere in Europe.
The primary process
All medicines, with the exception of veterinary medicines, botanicals and novel foods, are assessed by 4 pharmacotherapeutic groups (PT groups).
These PT groups are organised by medical condition. For example PT group 1 assesses the dossiers of groups of medicines used in conjunction with the central nervous system, such as painkillers, and PT group 3 is responsible for assessing, e.g., oncological medicines.
The Regulatory Information Centre (RIC) is responsible for processing incoming and outgoing data and also does some of the case management work (such as amendments to medicine dossiers).
There are also units with specialist knowledge which can be engaged in relation to specific elements of, and moments in, the assessment process. For example, the Quality unit checks whether the medicine's constant quality and user friendliness are sufficiently safeguarded. Other things we assess include the quality checks on active substances and excipients, the manufacturing process, the suitability of the packaging and any resources and the shelf life. The Pharmacology, Toxicology and Pharmacokinetics unit assesses, for example, how the medicine's active substance behaves in the body and examines how different medicines interact.
Following the assessment by the Agency, the Board takes a decision regarding the marketing authorisation of the medicine for the Dutch or European markets. Even when a medicine has been authorised for the Dutch or European markets, the MEB continues to monitor the risks. For example, the Pharmacovigilance unit, together with the PT groups, assesses signals of new risks and/or adverse reactions.
The MEB as a whole is authorised to perform its tasks. Because many decisions have to be taken, the MEB mandates its authorities. The Authorities- and signing table states which officer has which authorities. The authorities to make decisions, to represent the MEB and to adopt recommendations also include a signing authority. The Board authorizes the chairman to decide which persons are designated as Authorised Signatories.The list of names of employees who have a mandate of authorisation from the MEB can be requested from the MEB.
Veterinary Medicines and novel foods
Besides assessing medicines for human use, the Agency also assesses veterinary medicines and novel foods. However, the MEB is not responsible for the decision-making and the issuing of marketing authorisations of veterinary medicinal products and novel foods.
The Veterinary Medicinal Products Unit prepares the decision-making of the Veterinary Medicines Board (Ctd). This Board advises the Minister of Agriculture, Nature and Food Quality, who is responsible for policy and politically responsible.
In the Netherlands the Ministry of Health, Welfare and Sport (VWS) is the competent authority for assessment of novel foods. The Minister submits requests for a scientific assessment of consumer safety to the MEB's Novel Foods Unit.
In addition to the support units and the primary process, the MEB also has two programmes on the proper use, and the science, of medicines.