06/02/2019
Managing partner of the law firm Herbert Smith Freehills in Italy, Laura Orlando is one of Italy’s leading life sciences specialists, with a focus on IP and regulatory matters. Together with Sara Balice, one of the firm’s senior associates they examine the Court of Justice of the European Union’s (CJEU) ruling on the Reimbursement of off-label medicinal products. It is the responsibility of EU Member States to control off-label use of medicinal products. Under EU Legislation (Directive 2001/83/EC, the “Directive”), a medicinal product may only be placed on the market of a Member State if a marketing authorisation has been issued by the competent authorities. The terms under which a medicinal product can be used safely and efficaciously are described in the product information, which is an integral part of the marketing authorisation process. Off-label use refers to any intentional use of an authorised product not covered by the…
20/04/2021
15/04/2021
