Indehaveren af markedsføringstilladelsen skal sikre at undervisningsmaterialet udleveres til og gennemgås af de nationale patientorganisationer eller, hvis en sådan organisation ikke findes eller ikke kan involveres, af en relevant patientgruppe.
The MAH should ensure that the educational materials are provided to and reviewed by the national patients’ organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.