Detaljerne omkring implementering af post- marketingovervågningsstudiet skal aftales med den kompentente nationale myndighed i hvert medlemsland, og det skal sikres, at studiet er klart inden markedsføring af produktet.
Details of the implementation of the post-marketing surveillance study should be agreed with the National Competent Authorities in each member state and put in place prior to marketing of the product.