Subsection 4: Ongoing evaluation of the criteria for granting early access authorisation and transmission of new data

In order to be able to continuously assess the criteria mentioned in I of Article L. 5121-12, the Haute Autorité de santé and, where applicable, the Agence nationale de sécurité du médicament et des produits de santé may at any time ask the holder of the exploitation rights for the medicinal product covered by the early access authorisation or, where applicable, its authorised representative, to send it data enabling it…

The holder of the marketing rights for the medicinal product which is the subject of the early access authorisation or, where applicable, his authorised representative, shall immediately forward to 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 nationale de sécurité du médicament et des produits de santé, indicating…