Relevant additional information concerning unexpected serious adverse reactions, serious incidents and new facts mentioned in Article L. 1123-10 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé and to the relevant Committee for the Protection of Individuals without delay from the day on which the sponsor becomes aware of them. The latter will send a copy of the above-mentioned declarations and additional information to the Agence de la biomédecine for information purposes.
Article R1125-22
Updated 6 Nov 2023

