The Health Care Inspectorate (IGZ) has developed a risk model to gather information about the risks that may derive from the pharmacovigilance system managed by marketing authorisation holders. To complete the model, IGZ will send a mandatory online questionnaire in May 2017 to all marketing authorisation holders (MAH) of medicinal products authorised for the Dutch market through either the national, centralised, mutual recognition or decentralised procedure. MAH have to complete the questionnaire regardless of whether they are based in the Netherlands or whether the product is actually marketed in the Netherlands.
The questions will relate, among other things, to the EU Qualified Person for Pharmacovigilance (QPPV), the Pharmacovigilance System Master File (PSMF), marketing authorisation(s), amendments to the pharmacovigilance system, contracts and agreements, pharmacovigilance activities (including any outsourcing thereof), risk management, quality management, product safety and previous pharmacovigilance inspections of the pharmaceutical company concerned. On the basis of the answers received, the marketing authorisation holders will be placed in certain risk categories, and those failing to properly complete the questionnaire will automatically be placed in the maximum risk category. The questionnaire will need to be completed once every three years.
Pharmacovigilance falls within the competence of both the Medicines Evaluation Board and IGZ, while the supervision of the execution of pharmacovigilance by companies is a specific task of IGZ.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, April 2017 Issue (Thomson Reuters).