Indehaveren af markedsføringstilladelsen skal implementere programmet nationalt for at sikre, at alt sundhedspersonale, som har til hensigt at ordinere (og hvor det er relevant, og efter aftale med den kompetente, nationale myndighed, udlevere) Volibris, har fået udleveret følgende:
The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing (and where appropriate and in agreement with the National Competent Authority, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following: