Indehaveren af markedsføringstilladelsen skal til CPMP, referencemedlemsstaten og de berørte medlemsstater fremsende en PSUR, herunder en rapport om sit svangerskabsforebyggende program for isotretinoin og en integreret vurdering af eksponering af gravide og resultaterne heraf.
The MAH should submit to the CPMP, the Reference Member State and the Concerned Member States, a PSUR including a report on their isotretinoin Pregnancy Prevention Programme and an integrated assessment of pregnancy exposures and outcomes.