CJEU on authorisation for placing on the market a new therapeutic use of a known active ingredient23-07-2021 Print this page
Article 3(d) of Regulation No 469/2009 must be interpreted as meaning that an MA cannot be considered to be the first MA, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.
The referring court requests the Court of Justice, in essence, to interpret the concept of ‘first [MA for the product] as a medicinal product’ for the purpose of Article 3(d) of Regulation No 469/2009.
The CJEU ruled that that the first Marketing Authorisation (MA) for the product as a medicinal product means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue, irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that MA was obtained.
The fact that an active ingredient or combination of active ingredients is used for a new therapeutic application does not mean that there is a different product when that active ingredient or combination has been used for another, already known therapeutic application.