How we conduct inspections
The Health and Youth Care Inspectorate supervises the enforcement of health legislation as well as oversees the quality of the pharmacovigilance system and ensures that the marketing authorisation holders (MAH) comply with the existing Dutch and EU regulations. In order to verify the compliance, the Inspectorate conducts several pharmacovigilance inspections in the Netherlands and other EU member states. In the following paragraphs you can read more about how we work and what we do when there is a case of non compliance.
Marketing authorisation holders (MAH) of medicinal products with a Dutch marketing authorisation fall under the jurisdiction of the Inspectorate. Pharmacovigilance inspections are carried out to ensure the MAHs’ compliance with pharmacovigilance requirements laid down in the Dutch Medicine’s Act and Directive 2001/83/EC [REG Art 19]. These national pharmacovigilance inspections can either be systems-based or product-related.
Systems-based inspections are designed to review the procedures, systems, personnel, and facilities in place and determine their compliance with regulatory pharmacovigilance obligations. As part of this review, product specific examples may be used to demonstrate the operation of the pharmacovigilance system. Product-related pharmacovigilance inspections are primarily focused on product-related pharmacovigilance issues, including product-specific activities and documentation, rather than a general system review. Some aspects of the general system may still be examined as part of a product-related inspection (e.g. the system used for that product).
Marketing authorisation holders are prioritised for national inspection according to the risk rating obtained via WBS.
The Netherlands is the supervisory authority for pharmacovigilance of marketing authorisation holders of centrally authorised products when the pharmacovigilance system master file (PSMF) is located in the Netherlands [REG Art 18(3)]. Inspections are carried out in accordance with the EU inspection plan adopted by the Committee on Human Medicinal Products (CHMP). The aim of these inspections is to verify, on behalf of the EU, that the marketing authorisation holder for the medicinal product satisfies the pharmacovigilance requirements laid down in Directive 2001/83/EC [REG Art 19].
Routine and triggered inspections
Routine pharmacovigilance inspections are inspections scheduled in advance as part of a national programme incorporating also the EU inspection plan. Triggered/for cause pharmacovigilance inspections are undertaken when a trigger is recognised, and an inspection is considered an appropriate way to examine the issue. For cause inspections are more likely to focus on specific pharmacovigilance processes or to include an examination of identified compliance issues and their impact for a specific product. However, full system inspections may also be performed resulting from a trigger.
Inspection process and outcome
For national and EU pharmacovigilance inspections the Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections is followed.
Inspections findings are graded either:
- Critical (CR): a deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines.
- Major (MA): a deficiency in pharmacovigilance systems, practices or processes that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines.
- Minor (MI): a deficiency in pharmacovigilance systems, practices or processes that would not be expected to adversely affect the rights, safety or well-being of patients or pose a risk to public health.
Regulatory actions and sanctions
When non-compliance with pharmacovigilance obligations is detected, the necessary action will be judged on a case-by-case basis. What action is taken will depend on the potential negative public health impact of the non-compliance(s), but any instance of non-compliance may be considered for enforcement action. Actions may be taken by the Inspectorate, Medicines Evaluation Board (MEB) or European Medicines Agency (EMA) as appropriate. Regulation (EC) No 658 /2007 also empowers the Commission to impose financial penalties on marketing authorisations holders to ensure the enforcement of certain obligations connected with marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726 /2004.
If the Inspectorate imposes a financial penalty, the inspectorate will adhere to the policies for civil penalties (in Dutch) of the Minister of Health, Welfare and Sport.
The pharmacovigilance team will make public all inspection reports, originating from the National inspection programme per February 1st 2019, in compliance with the Dutch Health Law. For inspection reports originating from the European inspection programme, the policy of the European Medicines Agency will be followed and these reports will not be made public.
Are you a marketing authorisation holder and would you like more insight into the process of public disclosure? Please take a look at this page (in Dutch).