Judgment of the General Court (Ninth Chamber) of 26 January 2022.#Mylan IRE Healthcare Ltd v European Commission.#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.#Case T-303/16.