NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Pharmaceuticals In the Netherlands, medicinal products are primarily regulated under the Medicines Act and at EU level. As marketing authorisation procedures are largely harmonised within the European Union, accelerated pathways are generally pursued within the European regulatory framework. One such mechanism is the accelerated assessment procedure, based on Article 14 (9) of Regulation (EC) No 726/2004. Pursuant to this provision, the assessment period under the cen- tralised marketing authorisation procedure may be reduced from the standard 210 days to 150 days, pro- vided that the medicinal product is of major interest from the perspective of public health and, in particular, represents therapeutic innovation. In addition, Article 14a Regulation (EC) No 726/2004 provides for the possibility of a Conditional Marketing Authorisation. On the basis of this provision, a medici- nal product intended for the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases may be granted a marketing authorisation prior to the submission of comprehensive clinical data, provided that: (i) an unmet medical need exists; (ii) the benefit of immediate availability outweighs the risk inherent in the fact that additional data are still required; and (iii) the applicant undertakes to submit the outstanding data within an agreed timeframe. Furthermore, an application can be made for a duplex marketing authorisation (if specific conditions are met – eg, the reference product has not been granted a marketing authorisation via a duplex procedure or via the centralised procedure). A duplex marketing authorisation is a marketing authorisation for a medici- nal product for which the dossier at the time of the application for the marketing authorisation is identical to that of a previously registered product (see policy document “MEB 16: Duplex marketing authorisation”). In principle, the issuance of the duplex marketing authorisation is carried out within 45 days.
a complaint or report about a product they imported or sold (or if such product does not meet the require- ments) and (ii) report to the Inspectorate if a medical device presents a serious risk. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations Pharmaceuticals The MEB discloses information on (i) whether there is an application pending for (parallel import) marketing authorisations for a specific active substances and (ii) withdrawn and refused applications for marketing authorisations. As regards the latter, the MEB pro- vides the name of the medicinal product, the relevant active substance, the type of procedure (eg, national), whether the application is withdrawn or refused, and the public assessment report. Furthermore, the MEB also publishes official product information of all medicinal products that have mar- keting authorisation in the Netherlands. The informa- tion includes an overview of: • new marketing authorisations; • new homeopathic marketing authorisations; • withdrawn and suspended marketing authorisa- tions; • new marketing authorisations with a new active substance in the Netherlands; • new marketing authorisations authorised by the European Commission; • approved compassionate use programmes; and • scientific substantiation for suspended, refused and withdrawn marketing authorisations. The above is published in the Medicines Informa- tion Bank ( Geneesmiddeleninformatiebank ), which is updated on a weekly basis. Medical Devices In the context of medical devices, it is of note that EUDAMED may provide for access to certain informa- tion (eg, clinical performance). EUDAMED is not yet fully functional, as not all modules have been rolled out. • revised SmPC’s or package leaflets; • (revised) public assessment reports;
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