NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
3.3 Period of Validity of Marketing Authorisations
case the medical device has undergone significant changes. The notified body may suspend or withdraw a CE cer- tificate (or impose restrictions on it) if it finds that the requirements imposed by law are no longer met by the manufacturer (Article 56 (4) MDR). The IGJ can demand that the notified body suspend or withdraw a CE certificate. 3.4 Procedure for Obtaining a Marketing Authorisation Procedure for Obtaining a Marketing Authorisation (Medicinal Products) Every pharmaceutical that is marketed in the Neth- erlands must have a marketing authorisation (Article 40 Medicines Act). A marketing authorisation can be obtained through several procedures which are out- lined below: • a national procedure that is under the responsibility of the MEB and which, if completed successfully, will result in a marketing authorisation that is only valid for the Dutch market; • a decentralised procedure, which is a European authorisation procedure that – on the basis of identical documentation – allows for a marketing authorisation to be granted simultaneously in two or more EEA countries; • a mutual recognition procedure, which allows for the extension of a marketing authorisation already issued in another member state (the reference member state) to one or more EEA countries; and • a centralised procedure, which is under the responsibility of EMA and allows for the provision of a marketing authorisation that is valid across all EU countries; this procedure is compulsory for, for instance, orphan medicines. For the purposes of the national procedure, an appli- cation must be submitted to the MEB that includes information about the quality, safety and efficacy of the pharmaceutical. Based on the provided informa- tion and documents, the MEB will conduct a risk-ben- efit assessment. The applicant is responsible for the accuracy of the submitted information and documents (Article 45 (3) Medicines Act). A decision by the MEB on whether a marketing authorisation will be provided
Validity (and Renewal) of Marketing Authorisation A marketing authorisation is valid for a period of five years (Article 47 (1) Medicines Act). The marketing authorisation can be renewed at the request of its holder. Nine months prior to expira- tion of the marketing authorisation, the marketing authorisation holder is required to submit to the MEB a consolidated version of the registration file. Such consolidated file is required to include (i) the chang- es made since the marketing authorisation was first granted and (ii) the review of suspected adverse reac- tion reports and periodic safety reports. After carrying out a risk-benefit assessment the MEB may decide to grant a renewal for an indefinite period or a (once- only) renewal of five years. A reason why the MEB may decide to not grant a renewal for an indefinite period of time is if the pharmaceutical has been exposed to an insufficient number of patients. Suspension and Other (Enforcement) Measures Article 51 Medicines Act lays down several circum- stances under which the MEB will suspend, vary or withdraw a marketing authorisation, for instance if: • a pharmaceutical is harmful; • the therapeutic effect is absent or the risk-benefit assessment is unfavourable; • the requirements relating to labelling or the pack- age leaflet have not been observed; or • the obligations regarding pharmacovigilance have not been complied with. The MEB can also withdraw a marketing authorisation upon the request of its holder. Furthermore, if a phar- maceutical has not been marketed for a consecutive period of three years, the marketing authorisation will be deemed invalid. Medical Devices A CE certificate is valid for a maximum period of five years. Upon the request of the manufacturer, this period can be extended (each time for a maximum period of five years). A declaration of conformity by the manufacturer of a medical device is valid for an indefinite period, though it should be re-issued in
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