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Document 62025CN0877
Case C-877/25, Organon: Request for a preliminary ruling from the Raad van State (Netherlands) lodged on 30 December 2025 – College ter beoordeling van geneesmiddelen and Others v Organon NV
Case C-877/25, Organon: Request for a preliminary ruling from the Raad van State (Netherlands) lodged on 30 December 2025 – College ter beoordeling van geneesmiddelen and Others v Organon NV
Case C-877/25, Organon: Request for a preliminary ruling from the Raad van State (Netherlands) lodged on 30 December 2025 – College ter beoordeling van geneesmiddelen and Others v Organon NV
OJ C, C/2026/1763, 30.3.2026, ELI: http://data.europa.eu/eli/C/2026/1763/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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Official Journal |
EN C series |
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C/2026/1763 |
30.3.2026 |
Request for a preliminary ruling from the Raad van State (Netherlands) lodged on 30 December 2025 – College ter beoordeling van geneesmiddelen and Others v Organon NV
(Case C-877/25, Organon)
(C/2026/1763)
Language of the case: Dutch
Referring court
Raad van State
Parties to the main proceedings
Appellants: College ter beoordeling van geneesmiddelen, Laboratorios Cinfa SA, Laboratorios Normon, SA, Zentiva k.s., Win Medica SA, Refarm SA
Respondent: Organon NV
Questions referred
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1. |
Must Article 10b of Directive 2001/83/EC (1) on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC (2), be interpreted as meaning that, once a marketing authorisation has been granted for a particular combination of active substances, a subsequent authorisation for the same combination of active substances may also be granted on the basis of that article? |
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2. |
Is the therapeutic indication applied for in respect of the subsequent combination medicinal product relevant to the answer to the first question? |
(1) 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 (OJ 2001 L 311, p. 67).
(2) Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34).
ELI: http://data.europa.eu/eli/C/2026/1763/oj
ISSN 1977-091X (electronic edition)