Chapter I: General provisions

I. – On the basis of the information referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R. 5121-76-2, the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) shall assess the efficacy and safety of the medicinal product in the indication in…

The compassionate prescribing framework drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé states in particular, for each medicinal product: 1° The therapeutic indication(s) concerned; 2° The dosage and method of administration; 3° Adverse reactions; 4° The classification of the medicinal product in the categories mentioned in article R. 5121-36, if different from that indicated in the marketing authorisation. It…

I. – Except when the Agence nationale de sécurité du médicament et des produits de santé makes use of the derogation mentioned in V of article L. 5121-12-1, the compassionate prescription framework is accompanied by a protocol for therapeutic use and patient follow-up. This protocol specifies in particular 1° The procedures for monitoring patients and the data to be collected concerning the efficacy and safety of the medicinal product in…

Once a reference medicinal product, within the meaning of 5° of Article L. 5121-1, or a reference biological medicinal product, within the meaning of 15° of the same Article, is covered by a compassionate prescribing framework, medicinal products from the same generic group or the same similar biological group authorised after the compassionate prescribing framework was established are deemed to be covered by the compassionate prescribing framework. The holder of…

The cost of monitoring treated patients is borne by the marketing authorisation holder for the medicinal product or by the company which operates the medicinal product and which has been authorised to do so by the marketing authorisation holder. The marketing authorisation holder or the company organises the collection of data by the prescribers mentioned in Article L. 5121-12-1. When the compassionate prescription framework concerns several medicinal products, the cost…

I. – If required for public health reasons, in the event of a breach of the obligation to monitor patients and collect information, or if the conditions set out in Article L. 5121-12-1 are no longer met, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or revoke the compassionate prescribing framework. He may modify the compassionate prescribing framework for the…

The Agence nationale de sécurité du médicament et des produits de santé publishes on its website : 1° The initial compassionate prescribing framework, the protocol for therapeutic use and patient follow-up and any amendments, indicating the date on which they come into force and the date on which they cease to have effect; 2° Summaries of the periodic summary reports approved by the Director General of the Agency; 3° The…

Any measures taken by the marketing authorisation holder or the company operating the marketing authorisation to disseminate the compassionate prescribing framework or any information relating to this framework to the healthcare professionals concerned must not constitute advertising within the meaning of Article L. 5122-1. These measures are subject to the prior opinion of the Agence nationale de sécurité du médicament et des produits de santé. The draft measure is forwarded…