TY - JOUR T1 - Off-Label Use Reimbursement: A Review of the Status Quo in the Context of the Recent Novartis/AIFA Case A1 - von Czettritz, Peter A1 - Meier, Alexander PY - 2019 N2 - 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. JF - European Pharmaceutical Law Review JA - European Pharmaceutical Law Review VL - 3 IS - 2 UR - https://doi.org/10.21552/eplr/2019/2/5 M3 - doi:10.21552/eplr/2019/2/5 ER -