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 laid down by the Agency. Where the medicinal product is the subject of a marketing authorisation in another Member State or a State party to the European Economic Area and there is sufficient experience of the conditions of use of the medicinal product in the indication concerned, the follow-up data may not be required.

II.-The prescribing doctors and pharmacists or persons mentioned in article L. 5126-10 concerned and, in the case of a compassionate access authorisation granted in application of the second paragraph of II of article L. 5121-12-1, the holder of the exploitation rights for the medicinal product or its authorised representative must comply with the obligations set out in the protocol.

These prescribing doctors and pharmacists are required to participate in the collection of data.

For authorisations under the second paragraph of II of Article L. 5121-12-1, an agreement between the holder of the exploitation rights or, where applicable, his authorised representative and the health establishment in which the data is collected sets out the arrangements for compensating the latter in application of the first paragraph of V of Article L. 5121-12-1. This agreement conforms to the model laid down by order of the ministers responsible for health and social security.

When data is collected using an interface enabling electronic data entry, identification and authentication enabling access to this interface are ensured by using a dematerialised service designated by order and implemented by the agency referred to in Article R. 6113-33.

III - The therapeutic use protocol is updated by the Director General of the Agency on the basis of new data relating to the safety of the medicinal product which are brought to the Agency's attention.