NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
In emergency situations, a marketing authorisation may even be granted in the absence of complete pre- clinical or pharmaceutical data. Medical Devices Dutch law – in line with the MDR – does not provide for a formal fast-track registration procedure for medical devices. Market access is obtained through the regu- lar CE conformity assessment system. Limited and temporary derogation mechanisms (such as Article 59 MDR) do exist for urgent public health interests; however, these do not constitute a structural acceler- ated pathway. 4.2 Regulatory Reliance Pharmaceuticals EU-based reliance Within the EU, regulatory reliance is structurally embedded in three main procedures, as mentioned in 3.4 Procedure for Obtaining a Marketing Authori- sation . Non-EU-based reliance The Netherlands does not automatically recognise a marketing authorisation issued outside the EU. An EU- compliant application is always required. However, the EU has concluded Mutual Recognition Agreements with certain countries, which primarily concern the recognition of GMP inspections and, in some cases, batch testing. The MEB also participates in various pilot programmes of mutual regulatory reliance man- If a device has obtained a valid CE marking in accord- ance with the MDR or IVDR, it may be placed on the market in all EU member states, including the Neth- erlands, and no additional national product approval is required. Non-EU-based reliance There is no automatic recognition. An independent EU-compliant conformity assessment is mandatory. Such conformity certificate at EU level (granted by an EU notified body) is also required when a marketing authorisation for the device has been obtained from a third-country regulatory agency. However, the rel- aged by the EMA. Medical Devices EU-based reliance
evant EU notified body may take the findings of such third-country regulatory agency into account when conducting its conformity assessment. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceuticals Under Dutch law, manufacturing sites/manufacturers of medicinal products are subject to a prior manufac- turing authorisation pursuant to the Dutch Medicines Act. Without such authorisation, it is prohibited to manufacture, package, label, test, release or import medicinal products from third countries. The authori- sation is granted by Farmatec on behalf of the MoH, while the IGJ is responsible for inspections and super- vision. The authorisation is obtained by submitting an appli- cation to Farmatec. Following a positive assessment, the authorisation is granted for an indefinite period and remains valid as long as the statutory require- ments are met. However, it may be suspended or revoked in case of non-compliance. Medical Devices Manufacturers of medical devices are not subject to a prior authorisation requirement. They must, however, comply with the MDR or, where applicable, the IVDR. In addition, manufacturers are required to register in accordance with the applicable regulatory framework (see Article 31 MDR and Article 28 IVDR). 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and
Medical Devices Pharmaceuticals
Parties that are engaged in the wholesale distribution of medicinal products in the Netherlands are subject to a wholesale distribution authorisation.
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