Subsection 5: Suspension, withdrawal and termination of compassionate access authorisation

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw a compassionate access authorisation if the conditions laid down in I, II and V of Article L. 5121-12-1 or the provisions of this section are not complied with, or for any other public health reason. Except in cases of urgency, suspension or withdrawal may only take place after the authorisation…

I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall set the date on which the granting of these authorisations ceases. This date shall be determined having regard to the date of notification of the marketing authorisation and the period required for the medicinal product to…