Judgment of the Court (Fourth Chamber) of 19 March 2026.#Almirall BV and Almirall SA v Infinity Pharma BV and Pharmaline BV.#Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Scope – Article 2(1) – Medicinal products prepared industrially or manufactured by a method involving an industrial process – Article 3(2) – Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question – Exclusion from the directive’s scope – National regulation subjecting the latter medicinal products to an authorisation requirement on the basis of a numerical criterion.#Case C-589/24.