NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
placed on the market in the Netherlands (unless they have a marketing authorisation). Medical Devices Medical devices without a CE marking may, in certain circumstances, be used. Indeed, there is a specific consent procedure for medical devices and in vitro diagnostic medical devices, under which the MoH – advised by the IGJ – may provide an exemption. In order to qualify for such exemption, a manufacturer has to submit an application with the Central Informa- tion Point for Healthcare Professions ( Centraal Infor- matiepunt Beroepen Gezondheidszorg , CIBG), which is an executive organisation of the Ministry of Health, Welfare and Sport. An exemption is, in principle, only provided if (i) in the absence of such exemption, an unacceptable risk will arise for patient care in the Netherlands, (ii) no equiva- lent alternative is available, and (iii) if the manufacturer has made it plausible that the device is safe and meets the quality and safety requirements as described by applicable laws and regulations. 3.6 Ongoing Obligations Imposed by Marketing Authorisations Pharmaceuticals The marketing authorisation holder is required to carry out pharmacovigilance. In that respect, the holder of a marketing authorisation is required to, inter alia: • have (per medicinal product) a pharmacovigilance system in place (Article 76a Medicines Act), which is required to tie in with the pharmacovigilance system of the MEB (which keeps its own, more abstract, pharmacovigilance system); • keep up to date a pharmacovigilance system mas- ter file (PSMF); • implement a risk management system (that is documented in an up-to-date risk management plan); • conduct audits and designate a qualified person that is responsible for pharmacovigilance; • register all suspected adverse effects that appear in the EU (or third countries) and that the marketing authorisation holder is notified of; • (electronically) submit periodic safety update reports (PSUR) to the EMA;
• keep up to date the product information based on up-to-date scientific knowledge; and • give public notice (on the basis of pharmacovigi- lance information) of risks concerning the use of medicinal products. Furthermore, the MEB is authorised to impose a range of additional obligations on a marketing authorisa- tion holder, including requirements to carry out post-authorisation efficacy studies or to comply with enhanced registration and notification obligations that go beyond standard pharmacovigilance requirements. These (additional) obligations can be imposed during the application procedure (for a marketing authorisa- tion), but can also, if needed, be imposed after a mar- keting authorisation has been provided. Medical Devices A manufacturer is required to conduct post-market surveillance in order to monitor the safety and perfor- mance of the medical device that has been placed on the market. For that purpose, a post-market surveil- lance system (PSM system) needs to be implemented by the manufacturer. Such PSM system includes the collection of data ensuring the device’s performance and safety, and is used, inter alia: • to verify whether the benefit/risk ratio has remained favourable; • for clinical evaluation purposes; • to assess when modifications or corrective actions need to be made; • to assess what it can do to improve the usability, performance and safety of the device; and • to monitor the design and the production process. Furthermore, the manufacturer must notify the Inspec- torate if (i) there is an incident in which its medical device is involved and (ii) a corrective action has been performed in relation to the medical device. A manufacturer or distributor is also obligated to report any expected supply interruptions to the Healthcare Procurement Network Netherlands. Importers are required to keep a register of complaints, recalled and withdrawn devices, and devices that do not meet the requirements. Finally, importers and distributors must (i) inform the manufacturer, the authorised representa- tive (and/or the importer) immediately, if they receive
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