marketing authorisation

The medicinal products range in the Netherlands contains about 16,000 authorised medicinal products, including approximately 4,000 homeopathic medicinal products. Before a medicinal product may be brought onto the market in the Netherlands, it must be authorised (also referred to as a marketing authorisation) by the Medicines Evaluation Board (MEB). The MEB evaluates the medicinal product based on criteria cited in the Dutch Medicines Act and sets the conditions for authorising the product for marketing in the Netherlands.

More information on authorisation of medicinal products can be found to the right in the menu box ‘Topics at marketing authorisation’.

The MEB is responsible for authorising medicinal products for the market and for pharmacovigilance of products already on the market. This task is mainly aimed at protecting public health. It finds expression in the following core activities of the MEB concerning medicinal products for human use:

• Evaluation of medicinal products: High-quality and rapid evaluation of application files
• Scientific advice: High-quality interaction – in the form of recommendations – with the innovative industry to support innovation and product development
• Pharmacovigilance: High-quality monitoring of the efficacy and safety of medicinal products on the market

The responsibility for the evaluation, authorisation and pharmacovigilance of medicinal products for human use – including homeopathic and herbal medicines – rests with the MEB, which consists of doctors, pharmacists and scientists. The MEB has independent authority to take decisions on the availability of these medicinal products. The MEB is responsible for both the authorisation and monitoring of effective and safe medicinal products on the Dutch market and is jointly responsible for the approval of the medicinal products throughout the European Union.

The members of the MEB are supported in their work by the more than 180 employees of the MEB Agency. As part of the Ministry of Health, Welfare and Sport (VWS), the Agency is responsible for preparing and implementing the decisions of the MEB and for coordination of pharmacovigilance in the Netherlands.

Given the ambition of the MEB to remain among the top five within the EU network of regulatory medicine authorities, the MEB has developed special interest areas related to medicinal products for human use. These areas of special interest are psychiatry, vaccines, female hormones, cardiovascular disease and oncology.