PHARMACEUTICAL REGULATIONS: REIMBURSEMENT OF A MEDICINAL PRODUCT FOR A USE NOT COVERED BY ITS MARKETING AUTHORIZATION
Judgment of 21 November 2018 in Case C-29/17 Novartis Farma SpA / Agenzia Italiana del Farmaco (AIFA) e.a. The EU Court of Justice (ECJ) has ruled that under Articles 3 and 6 of Directive 2001/83 relating to medicinal products for human use and Articles 3, 25 and 26 of EU Regulation n° 726 / 2004 […]