Medlemslandene skal sammen med indehaveren af markedsføringstilladelsen aftale detaljerne omkring implementering af post- marketingovervågningsstudiet i hvert medlemsland og sikre at studiet er klart inden markedsføring af produktet.
The Member States shall agree details of the implementation of the post-marketing surveillance study in each member state with the MAH and ensure that it is put in place prior to marketing of the product.