The reimbursement of authorised medicinal products for indications and uses outside of their authorised label – so-called “off-label use” – has become a hot topic in the EU. The recent judgment of the Court of Justice of the European Union (CJEU) of 21 November 2018 in the case C-29/17 addresses important crucial points for national reimbursement regimes. This article provides a critical review of this CJEU decision. In addition, the authors stipulate that Article 5(1) of Directive 2001/83/EC sets the frame for national reimbursement decisions according to which the off-label use of authorised medicinal products is limited to situations of 'special needs', as this would otherwise undermine the marketing authorisation (MA) system and render it ineffective.