NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
7.2 Importer of Record of Pharmaceuticals and Medical Devices Any company that has a manufacturing authorisation or a wholesale distribution authorisation can act as an importer of record. In that respect, it should be noted that importing medicinal products from outside the EEA requires a manufacturing authorisation. In terms of medical devices, any natural or legal per- son established within the European Union that places a device from a third country on the market can act as an importer of record. The importer must comply with the obligations set out in the MDR or IVDR, including, inter alia, registration obligations. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In order to import medicinal products, a wholesale distribution authorisation (if medicinal products are imported from EEA countries) and/or manufacturing authorisation is required (if medicinal products are imported from third countries). Furthermore, for import purposes it is also required to provide an import dec- laration to customs. There are several exemptions from the prior authorisa- tion requirements, for instance: • The Inspectorate can grant an import exemption in case of a severe shortage of a medicinal prod- uct. Whether such exemption is necessary is to be assessed by the Inspectorate in consultation with the MEB. The exemption only concerns medicinal products that are not registered in the Netherlands, but have a marketing authorisation in another member state or a third country (with which a mutual recognition agreement is in place). • An exemption applies to medicinal products authorised under compassionate use programmes. • Finally, an exemption also applies to in-transit/ export medicinal products (related to wholesale activities), which are not allowed to be placed on the market in the Netherlands (unless they have marketing authorisations). Regarding medical devices, as any medical device has to fully comply with the relevant EU regulatory requirements, the importation thereof from third coun-
In order to obtain a wholesale distribution authorisa- tion, an application must be submitted to Farmatec. A wholesale distributor must appoint a Responsible Person (RP) and show that the GDP will be complied with. The procedure is similar to that of the manufac- turing authorisation; reference is therefore made to 5.1 Requirements for Authorisation for Manufacturing Plants . The authorisation covers procuring (within the EER), having in stock, supplying or exporting medici- nal products into (or taking out of) Dutch territory. The costs of the application procedure amount to EUR1,700. The application will only be taken into consideration after payment of this fee. Furthermore, the holder of a wholesale distribution authorisation is obliged to pay a yearly fee of EUR1,600. The whole- sale distribution authorisation is, in principle, provided for an indefinite period. Medical Devices For medical devices, no separate wholesale distribu- tion authorisation is required. However, obligations do apply under, inter alia, the MDR and IVDR – eg, distributors must comply with specific quality, compli- ance, and traceability requirements (Article 14 MDR and IVDR). 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Categories of Pharmaceuticals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies In the Netherlands, the import and export of phar- maceuticals and medical devices are regulated by a combination of national legislation (Medicines Act / Medical Devices Act), EU pharmaceutical legisla- tion (including Directive 2001/83/EC), EU regulations (MDR, IVDR) and Customs legislation (UCC). Customs supervises and controls goods at the border. The Inspectorate exercises substantive supervision and enforces compliance both at the border and within the market.
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