In case of a shortage of a medicinal product, the MEB may issue a marketing authorisation for reasons of public health. This is a marketing authorisation without an application. In such cases, at the request of the MEB a company acts as the marketing authorisation holder and places a medicinal product that is authorised in another EU Member State on the Dutch market.
A marketing authorisation without an application can only be issued if the health of a large group of patients is negatively affected because a particular medicinal product is no longer available and there is no alternative product.
Because this is an exception to the regular process for issuing marketing authorisations, the exceptions have to be interpreted strictly. Until now, the MEB has not issued any marketing authorisations of this type. A marketing authorisation for reasons of public health is temporary. As soon as an authorised medicinal product is placed on the market again via the normal procedure, for example, the authorisation is annulled.
Preventing a shortage
There have been a number of occasions during previous years in which a medicinal product was unavailable (or not available in sufficient quantity) for a certain period. The causes are diverse. Minister of Health, Welfare and Sport Edith Schippers has asked the Dutch Medicinal Product Shortages working party to investigate measures that can be taken to prevent such shortages or to resolve them as well as possible. The MEB is represented in that working party. One of the steps for preventing shortages is having the MEB grant a marketing authorisation because of public health interests.
Definition in the Medicines Act
This exceptional authorisation is defined in the Medicines Act (Gmw), along with the ‘regular’ marketing authorisation and the parallel import marketing authorisation. This possibility is defined in Article 52 of the Medicines Act, which transposes Article 126a of Directive 2001/83/EC into national legislation. According to that article, the MEB may authorise a medicinal product for the Netherlands if it is authorised in another Member State of the European Union. The MEB takes the initiative to do so and also checks that this solution will not cause supply problems in the member state concerned. The organisation that is to act as the authorisation holder must declare that it will fulfil all obligations arising from the law.
Other solutions for preventing a shortage
Other solutions for preventing a shortage are a fast-track Mutual recognition procedure (MRP), a parallel import marketing authorisation or a modification to the existing dossier for a marketing authorisation.