The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.” As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”). Chapter III of the Directive sets out the new procedures for national marketing authorizations (“MAs”). This includes a purely national MA procedure granted in a single Member State … Read the rest
U.S. Courts News Reporter