Subsection 3: Therapeutic use protocol and data collection

I.-A.-Early access authorisations granted under article L. 5121-12 are subject to compliance with a therapeutic use and data collection protocol defined by the Haute Autorité de santé. The protocol is drawn up in conjunction with the Agence nationale de sécurité du médicament et des produits de santé when the authorisation is granted under 1° of II of Article L. 5121-12. When the early access authorisation is granted in application of…

As part of the monitoring obligations laid down in the therapeutic use protocol and the data collection obligations for all early access authorisations, the holder of the marketing rights for the medicinal product or, where applicable, its authorised representative, sends the Haute Autorité de santé, the ministers responsible for health and social security and, for the medicinal products mentioned in 1° of II of article L. 5121-12, to the Agence…