Risk-based pharmacovigilance survey

In order to effectively monitor  the compliance of Dutch MAHs’ with the Dutch and EU legislation, the Inspectorate is using a Risk-Based Pharmacovigilance questionnaire to collect information about the pharmacovigilance systems of these MAHs. It is mandatory for all Dutch MAHs to complete the survey. This survey contains general questions about the organisation, but also more specific questions about the pharmacovigilance system.

The information provided to the Inspectorate will be used to calculate a risk assessment score and to determine an organisation’s risk in comparison to other MAHs that have completed the WBS. These scores will be ranked and inspections prioritised for the companies with the highest risk assessment scores. Inspections will be planned according to how much inspection resource is available in the upcoming year.

The information provided to the Inspectorate are used to determine an organisation’s risk profile. Inspections will be prioritised for the companies with a high risk profile and these inspections will be planned according to the availability of resources in the upcoming years.

The risk-based survey of 2017 has been completed by the MAHs. Please refer to the section ‘results of the risk-based pharmacovigilance survey 2017’ for more information.

What is a ‘Dutch’ marketing authorisation holder?

A Dutch marketing authorisation holder is considered to be any organisation that holds an authorisation which enables it to place a medicinal product on the Dutch market. This includes national, mutual recognition, decentralised and centralised licenses. The country of the location of the organisation does not determine whether or not they are a Dutch MAH.