What we do

Every marketing authorization holder (MAH) for a medicinal product is responsible for the quality and safety of its products. The Dutch Health and Youth Care Inspectorate is the supervisory authority which monitors the pharmacovigilance activities of these MAHs in the Netherlands.

Every marketing authorization holder is subject to regular inspections. In order to effectively monitor the compliance of Dutch MAHs’ with the Dutch and EU legislation, the Inspectorate has developed a risk based pharmacovigilance questionnaire.

In the Netherlands, the Medicines Evaluation Board (MEB) has been designated as the national competent authority for the coördination of pharmacovigilance. They are responsible for the safety monitoring of medicinal products in the Netherlands and make the final decision about the authorisation of these products.

Laws and regulations