Indehaveren af markedsføringstilladelsen skal på tidspunktet for påbegyndelse af markedsføringen sikre, at alle sundhedspersoner, der forventes at ordinere/ anvende ReFacto AF, alle laboratorier, der forventes at monitorere patienter, der får ReFacto AF, og alle hæmofili- patientforeninger i EU får tilsendt undervisningsmateriale.
The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe/ use ReFacto AF, all laboratories that are expected to monitor patients receiving ReFacto AF and all EU Haemophiliac patients associations are provided with Educational packs.