Section 7a: Compassionate access authorisations

I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé publishes, on the Agency’s website, a reference database of medicinal products which are the subject of a compassionate access authorisation. For each medicinal product, this repository provides access to: 1° Where applicable, the criteria for granting compassionate access authorisation in a given indication and any information necessary for the use of the medicinal product;…

Any measures taken by the holder of the exploitation rights to disseminate any information relating to the compassionate access authorisation from which it benefits 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 to the Agency by…