Subsection 2: Investigation, authorisation, refusal, renewal

I.- When examining any request for authorisation for compassionate access, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has the prerogatives set out in Article R. 5121-34. II.- As soon as a first request for authorisation for compassionate access for a medicinal product in a specific indication is received, the Director General of the Agence nationale de sécurité du médicament et des…

I.- The maximum value of the period referred to in the second paragraph of II of article L. 5121-12-1 is set at twelve months from the date on which the authorisation referred to in this article is granted. By way of derogation from the previous paragraph, when the indication for which authorisation is sought is a rare disease, the maximum value of the period is increased to eighteen months from…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Article L. 5121-12-1 or if the provisions of this section are not complied with, or for any other public health reason.

I.- Authorisation for compassionate access is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé for the duration of treatment of the patient in question, up to a maximum of one year. This authorisation includes: 1° The name and contact details of the prescriber and the contact details of the pharmacy for internal use in the health establishment or of the…

I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. This request is accompanied by any clinical data of which the prescriber was aware during the previous authorisation period and a statement from the prescriber attesting to the interest in continuing the…