CELEX:62016TA0303: Case T-303/16: Judgment of the General Court of 26 January 2022 — Mylan IRE Healthcare v 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)