The holder of an authorisation must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by 15 February each year at the latest, an annual statement of the stocks held at 31 December of the previous year.
The Director General of the Agency may request a statement of the stocks held by the authorisation holder at any time. The authorisation holder must submit this statement to the Agency without delay.