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European Union
F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato (C-179/16)
Consideration of the questions referred
The second to fourth questions
59

F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato (C-179/16)

Judgment of 23 Jan 2018law://eu/cjeu/2016/c-179-16/para_59@2026-11-11

59It follows that the EU rules on pharmaceutical products prohibit neither the off-label prescription of a medicinal product nor its repackaging for such use but do require that they comply with the conditions laid down in those rules.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Key facts

Court: Court of Justice · Grand Chamber
Case: C-179/16 · ECLI:EU:C:2018:25
Decided: 23 Jan 2018
Procedure: Preliminary reference · referred by the Consiglio di Stato (Council of State, Italy)
Applicants: F. Hoffmann-La Roche Ltd; Roche SpA; Novartis AG; Novartis Farma SpA
Defendant: Autorità Garante della Concorrenza e del Mercato
Rapporteur: C.G. Fernlund
Advocate General: H. Saugmandsgaard Øe
Bench: 13 judges
K. Lenaerts, A. Tizzano, R. Silva de Lapuerta, M. Ilešič, J. Malenovský, C.G. Fernlund, C. Vajda, A. Borg Barthet, J.-C. Bonichot, A. Arabadjiev, F. Biltgen, K. Jürimäe, C. Lycourgos
Language: Italian
Official: CURIA · EUR-Lex 62016CJ0179

Topics

Approximation of laws Competition

History · 1 version

23 Jan 2018Reading

Connections

Interprets 1: Treaty on the Functioning of the European Union (consolidated 2016)
Cited by 24: Booking.com BV and Booking.com (Deutschland) GmbH v 25hours Hotel Company Berlin GmbH and Others (C-264/23); UL and SA Royal Antwerp Football Club v Union royale belge des sociétés de football association ASBL (C-680/21); Autoridade da Concorrência and Others v Ministério Público (C-331/21); Lietuvos notarų rūmai and Others v Lietuvos Respublikos konkurencijos taryba (C-128/21); European Superleague Company, SL v Fédération internationale de football association (FIFA) and Union of European Football Associations (UEFA) (C-333/21); UBS Group AG and Others v European Commission (T-441/21); Google LLC and Alphabet Inc. v European Commission (T-334/19); Servier SAS and Others v European Commission (C-201/19 P); Niche Generics Ltd v European Commission (C-164/19); European Commission v KRKA, tovarna zdravil, d.d (C-151/19); Teva UK Ltd and Others v European Commission (C-198/19); Unichem Laboratories Ltd v European Commission (C-166/19); European Commission v Servier SAS and Others (C-176/19 P); Debregeas et associés Pharma (D & A Pharma) v European Commission and European Medicines Agency (C-291/22 P); International Skating Union v European Commission (C-124/21 P); Super Bock Bebidas SA and Others v Autoridade da Concorrência (C-211/22); Polwax S.A. v European Commission (T-585/20); F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato (C-261/21)2 provisions; Polskie Linie Lotnicze 'LOT' SA v European Commission (T-240/18); Polskie Linie Lotnicze "LOT" SA v European Commission (T-296/18); Generics (UK) Ltd and Others v Competition and Markets Authority (C-307/18); GMP-Orphan (GMPO) v European Commission (T-733/17); Abraxis Bioscience LLC v Comptroller General of Patents (C-443/17); Staat der Nederlanden v Warner-Lambert Company LLC (C-423/17)
Cites 23: Treaty on the Functioning of the European Union (consolidated 2016)3 provisions; Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; Aleksei Petruhhin v Latvijas Republikas Ģenerālprokuratūra (C-182/15); Stichting Natuur en Milieu and Others v College voor de toelating van gewasbeschermingsmiddelen en biociden (C-266/09); Abcur AB v Apoteket Farmaci AB and Apoteket AB (C-544/13, C-545/13); Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance); NV Nederlandsche Banden Industrie Michelin v Commission of the European Communities (322/81); Hoffmann-La Roche & Co. AG v Commission of the European Communities (85/76); Competition Authority v Beef Industry Development Society Ltd and Barry Brothers (Carrigmore) Meats Ltd (C-209/07); Ministre du Budget, des Comptes publics et de la Fonction publique v Accor SA (C-310/09); Persidera SpA v Autorità per le Garanzie nelle Comunicazioni and Ministero dello Sviluppo Economico delle Infrastrutture e dei Trasporti (C-112/16); FSL Holdings and Others v European Commission (C-469/15 P); Fabio Caronna (C-7/11); Ordem dos Técnicos Oficiais de Contas v Autoridade da Concorrência (C-1/12); Groupement des cartes bancaires (CB) v European Commission (C-67/13 P); Asnef-Equifax, Servicios de Información sobre Solvencia y Crédito, SL v Asociación de Usuarios de Servicios Bancarios (Ausbanc) (C-238/05); Sot. Lélos kai Sia EE and Others v GlaxoSmithKline AEVE Farmakeftikon Proïonton, formerly Glaxowellcome AEVE (C-468/06); Protimonopolný úrad Slovenskej republiky v Slovenská sporiteľňa a.s (C-68/12); European Commission v Republic of Poland (C-185/10); Novartis Pharma GmbH v Apozyt GmbH (C-535/11); NV IAZ International Belgium and others v Commission of the European Communities (96/82, 97/82, 98/82, 99/82, 100/82, 101/82, 102/82, 104/82, 105/82, 108/82, 110/82); Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article 81(3) of the Treaty to categories of technology transfer agreements (Text with EEA relevance); MasterCard Inc. and Others v European Commission (C-382/12 P)