European Commission: European Court of Justice judgment on the definition of a medicinal product to be considered as a reference medicinal product in the meaning of Article 10 of the Directive 2001/83/CE

In its judgment of 18 June 2009 in case C-527/07, the European Court of Justice ruled that Directive 2001/83/EC is to be interpreted as meaning that only those medicinal products benefiting from a marketing authorisation issued in accordance with Community law in force at the time of the application and before being placed on the market can be considered to be reference medicinal products. In that regard, the Court stated that to allow a medicinal product benefiting from an authorisation issued on the basis of national provisions alone to be considered to be a reference medicinal product would amount, in fact, to authorising an exception to the rule, laid down in particular in Article 6(1) of Directive 2001/83. Moreover, there is no provision of Directive 2001/83 which supports the finding that the mere placing on the market, even for a number of years, of a medicinal product which has not been the subject of a marketing authorisation issued in accordance with Community law, can replace such authorisation.