Subsection 3: Protocol for therapeutic use and patient monitoring

I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient monitoring protocol. This protocol specifies in particular the indication concerned, the dosage, the conditions of prescription and dispensing, the obligations relating to pharmacovigilance and, where applicable, the monitoring data relating to efficacy and safety and the conditions of use…

Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where applicable, his authorised representative, sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé, at intervals established by the protocol, a report called a “periodic summary report”. This report includes in particular: 1° A summary…