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.

The WBS has 14 sections with questions related to the following topics: 

  • EU Qualified Person for Pharmacovigilance (QPPV) and national contact person 
  • Pharmacovigilance System Master File (PSMF) 
  • Marketing of products and license information 
  • Changes to the pharmacovigilance system 
  • Pharmacovigilance activities and compliance (case processing, PSURs, safety variations etc.) 
  • Contracts and agreements 
  • Outsourcing pharmacovigilance activities 
  • Risk management plan
  • Quality management system (training, procedures and auditing) 
  • Product related safety issues 
  • Previous pharmacovigilance inspections

The following key points should be noted:     

  • Information from MAHs are collected on a pharmacovigilance (PV) system level. However, the WBS should still be completed by every MAH, but not all parts need to be completed by every MAH who fall under the same PV system. You will able to specify this in the appropriate sections of the WBS. 
  • If the company has one or more marketing authorisations (MAs) for products on the Dutch markets, but no offices located in the Netherlands, the questionnaire should still be completed 
  • The questions apply to the all MAs for medicinal products in the Netherlands that are covered by the pharmacovigilance system, unless stated otherwise. 
  • If the company is not currently marketing any of the medicinal products in the Netherlands, but holds the MA, the questionnaire should still be completed. 
  • For the majority of the questions, any time-specific data requested will cover a period of 1 year (e.g. 1 January 2016 until 31 December 2016). 
  • Please be aware that failure to submit a completed WBS will be assessed as a high-risk answer to all questions.

Questions?

More information can be found in this document with frequently asked questions. If there are any further concerns or questions regarding the Risk-Based Pharmacovigilance questionnaire, please send an email to meldpunt@igj.nl.

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.