Health Care Inspectorate (IGZ) request to marketing authorisation holders: questionnaire for pharmacovigilance

The Dutch Health Care Inspectorate (IGZ) has developed a risk model for pharmacovigilance to obtain more insight into the risks of marketing authorisation holders with regard to their pharmacovigilance system. One of the resources that IGZ is using to collect this information, is an online questionnaire. It contains questions about the company and specific questions about the pharmacovigilance activities within the company.

All marketing authorisation holders will receive a letter in May this year containing the login details and they are all obliged to fill in the questionnaire. The questionnaire will then be sent to all marketing authorisation holders every three years. For more information about this, please visit the IGZ website.

Pharmacovigilance is an important task for both the Medicines Evaluation Board (MEB) and IGZ. Supervision on the execution and implementation of pharmacovigilance by companies is a specific task of IGZ.