Distinction AMM et hors AMM, de la prescription à la dispensation

The prescribing of a pharmaceutical speciality for an unapproved use, in terms of an indication, a posology or a particular population can lead to the non-respect of the initial marketing authorisation (MA), or being off-label. The respect of the MA imposes specific precautions and responsibilities not only for the prescribing physician but also for the pharmacist dispensing the medication.