Article R5121-74-7 of the French Public Health Code
November 2, 2023
In order to be able to continuously assess the benefit/risk balance of the medicinal product, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may at any time request the holder of the marketing rights for the medicinal product which is the subject of the compassionate access authorisation or, where applicable, its authorised representative, to provide it without delay with data enabling it…
