NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
sidered an autonomous administrative authority ( zelf- standig bestuursorgaan , ZBO). A ZBO holds a specific position within the central government, as they (i) are not part of any ministry and therefore independent, (ii) exercise public authority and (iii) not hierarchically subordinate to a specific minister. 1.2 Challenging Decisions of Regulatory Bodies In general, decisions by the regulatory bodies (eg, a decision to not grant a marketing authorisation or a decision to impose an administrative fine on a market- ing authorisation holder) are considered administrative decisions and are governed by the General Adminis- trative Law Act ( Algemene wet bestuursrecht , Awb). These decisions can be challenged by interested par- ties, within a specific period of time. • The initial decision by a regulatory body must be objected to within six weeks of notification thereof. The regulatory body is, in principle, obligated to decide on the objection within 12 weeks after the objection has been submitted, but may postpone this period. • Within six weeks of the date of the objection deci- sion, an appeal may be lodged against such deci- sion with the competent court. • Within six weeks of the date of a judgment by the competent court an appeal may be lodged with the highest administrative court. Other regulated markets and/or products have similar (administrative) procedures, as these markets and/or products are typically also under the supervision of a governmental body. For the sake of completeness: if, for instance, dam- ages are suffered as a result of an unlawful decision by the regulatory body, a claim can also be initiated with the civil court. 1.3 Categories of Pharmaceuticals and
Certain medicinal products may only be supplied on prescription; these are referred to as prescription-only medicines ( UR geneesmiddelen ). The Wet BIG speci- fies which healthcare professionals are authorised to prescribe medicines. These include physicians, dentists, midwives, physician assistants, and nurse specialists. In addition, certain specialised nurses are authorised to prescribe medicines, namely nurses specialised in diabetes mellitus, oncology, and asthma and COPD. The MEB determines whether a medicinal product requires a prescription. In addition, there are over- the-counter (self-care) medicines, which may be purchased without a prescription from pharmacies, drugstores, supermarkets, or petrol stations. Some over-the-counter medicines are available in the Neth- erlands exclusively through pharmacies, as it is con- sidered important that a pharmacist provides appro- priate advice on their use ( UA geneesmiddelen ). Other self-care medicines may be sold through pharmacies and drugstores only ( UAD geneesmiddelen ), while certain self-care medicines may also be sold in super- markets and petrol stations ( AV geneesmiddelen ). Medical Devices Pursuant to the MDR, medical devices in the Nether- lands are classified into Classes I (lowest risk), IIa, IIb and III (highest risk), taking into account the intended purpose designated by the manufacturer and the inherent risks associated with the device. Pursuant to the IVDR, devices are classified into Classes A (lowest risk), B, C and D (highest risk), tak- ing into account the intended purpose and the inher- ent risks associated with the device.
2. Clinical Trials 2.1 Regulation of Clinical Trials
EU law and domestic laws regulate clinical trials of medicinal products and medical devices. In the Netherlands, the primary regulatory framework for clinical research involving medicinal products is the Clinical Trials Regulation (EU) No 536/2014 (CTR). For research involving medical devices, the MDR is
Medical Devices Pharmaceuticals
In the Netherlands, a distinction is made between prescription-only medicines and over-the-counter (self-care) medicines.
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