Hvorledes indsamlingen af detaljerede data omkring indikationen kan gennemføres, så der opnås tæt overvågning af "off- label" - anvendelsen inden for eget, nationalt område
The MAH should also agree with each Member State prior to the launch of the product: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the off-label use within the national territory • The set-up of national measures to assess the effectiveness of and compliance with the PPP.