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.
In the beginning of 2020 the Inspectorate will send out a new questionnaire to all QPPV’s (Qualified Person Responsible For Pharmacovigilance) belonging to a ‘Dutch’ MAH (see What is a ‘Dutch’ marketing authorisation holder?) The questionnaire needs to be filled in by the QPPV.
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.
Risk score per MAH
The information provided to the Inspectorate will be used to calculate a risk 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 scores.
Previous risk-based survey
In 2017 the first risk-based survey was completed by the MAHs. Please refer to the section ‘results of the risk-based pharmacovigilance survey 2017’ for more information.