Mylan Ire Healthcare v Commission (Medicinal Products for Human Use – Orphan Medicinal Products – Tobramycin): ECFI 26 Jan 2022

Judgment – Medicinal products for human use – Orphan medicinal products – Marketing authorisations for the medicinal products Tobramycin VVB and associated names – Derogation from the market exclusivity of Tobi Podhaler, containing the active substance tobramycin – Article 8(3)(c) of Regulation (EC) No 141/2000 – Concept of ‘significant benefit’ – Concept of ‘clinical superiority’ – Article 3(2) and (3)(d) of Regulation (EC) No 847/2000 – Duty of care – Manifest error of assessment

Citations:

T-303/16, [2022] EUECJ T-303/16

Links:

Bailii

Jurisdiction:

European

Health

Updated: 07 May 2022; Ref: scu.671866