ECJ Judgment – Medicinal products for human use – Marketing authorisation for the generic medicinal product Zoledronic acid Hospira – zoledronic acid – Regulatory data protection period for the reference medicinal products Zometa and Aclasta, containing the active substance zoledronic acid – Directive 2001/83/EC – Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 – … Continue reading Novartis Europharm v Commission T-67/13: ECFI 15 Sep 2015

Judgment – Medicinal products for human use – Marketing authorisation for the generic medicinal product Zoledronic acid Teva Pharma – zoledronic acid – Regulatory data protection period for the reference medicinal products Zometa and Aclasta, containing the active substance zoledronic acid – Directive 2001/83/EC – Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 – … Continue reading Novartis Europharm v Commission T-472/12: ECFI 15 Sep 2015

ECJ Appeal – Medicinal products for human use – Suspension of the marketing and the withdrawal of certain consignments of medicinal products containing the active ingredient Clopidogrel -Variation of marketing authorisations – Prohibition on marketing – Regulation (EC) No 726/2004 and Directive 2001/83/EC – Precautionary principle – Proportionality – Obligation to state reasons A. Borg … Continue reading Acino v Commission: ECJ 10 Apr 2014

ECFI Medicinal products for human use – Application for authorisation to market the medicinal product Orphacol – Commission decision refusing to grant authorisation – Regulation (EC) No 726/2004 – Directive 2001/83/EC – Well-established medicinal use – Exceptional circumstances T-301/12, [2013] EUECJ T-301/12 Bailii Regulation (EC) No 726/2004, Directive 2001/83/EC European Updated: 15 November 2021; Ref: … Continue reading Laboratoires Ctrs v European Commission: ECFI 4 Jul 2013