The (statutory) tasks of the Medicines Evaluation Board (MEB) can generally be divided into 3 categories: assessing medicines, monitoring adverse reactions and risks and promoting the proper use of medicines. Another important statutory task is to provide scientific advice to pharmaceutical companies.
In the Netherlands, people who use medicines have access to around 20,000 authorised products. All those medicines have to comply with strict requirements. For example, the effect of a medicine must weigh up against the risks, the quality must be satisfactory and the patient information leaflet must be complete. As the medicines authority of the Netherlands, the MEB assesses each medicine that comes onto the market to ensure that it fulfils all the legal requirements. Once a medicine is available on the market, we continue to monitor it. Based on, for example, reported adverse reactions and other information, we monitor the safety of the medicine and take action if there is any danger. We do all this together with our national and European partners.
When determining whether a medicine can become available on the market, we primarily look at the balance between efficacy and risks. We ask ourselves which positive effects the medicine has and whether these weigh up against any adverse reactions. Then we ask how we can minimise the risks posed by a medicine. In our day-to-day work we focus constantly on assessing this balance. Only when it is positive and all other requirements have been fulfilled we give authorisation for the medicine to be marketed.
We systematically monitor any medicine that has been authorised for the Dutch market. Medicines can produce adverse reactions. Indeed, adverse reactions play an important role in deciding whether a medicine should become available on the market. However, patients or consumers sometimes experience other adverse reactions in daily practice or known adverse reactions may occur more frequently than expected. Very occasionally some other problem may occur, for example with the medicine's production. An extensive monitoring system is available to process all the signals, including at the international level. We take action wherever necessary.
Better use of medicines
When we assess a medicine we always have the eventual user in mind. After all, a medicine works better if people know exactly what they should use it for and how. That is why we focus a great deal of attention on understandable and reliable information on medicines, for example in the form of the patient information leaflet, as well as on the consideration of where a medicine should become available and whether the doctor might be needed to provide supervision.
When a new medicine is under development, companies can approach the MEB for scientific advice and may ask questions about the medicine's development plan. This enables the company to get more of an insight into all the requirements the medicine has to fulfil. Scientific advice from the MEB contributes to the responsible development of medicines.
Veterinary medicines and novel foods
In addition to medicines for human use, the MEB also plays a role in the assessment and monitoring of veterinary medicines. This task is carried out by the Veterinary Medicinal Products Unit. The Novel Foods Unit assesses and monitors novel foods.