Subsection 2: Investigation, authorisation, refusal, renewal

I.-For each of the indications for which an application for early access authorisation has been submitted as mentioned in article R. 5121-68, the Haute Autorité de santé will inform the applicant of its reasoned decision within three months of acknowledgement of receipt of the complete dossier. II. – When it concerns a medicinal product mentioned in 1° of II of Article L. 5121-12, the authorisation decision is taken after receiving…

In the event of an additional request by the Haute Autorité de santé during the assessment of the application referred to in Article R. 5121-68, where applicable on a proposal from the Agence nationale de sécurité du médicament et des produits de santé or the Ministers responsible for health and social security, the applicant has a period of time set by the Haute Autorité de santé which may not exceed…

I.-For the medicinal products mentioned in Article L. 5121-12, the early access authorisation: 1° Is granted for a maximum period determined by decree, renewable by the High Authority for Health; 2° Contains the name of the medicinal product or, where applicable, its code name or international non-proprietary name, its pharmaceutical form and its strength; 3° Specifies the therapeutic indication(s) for which the early access authorisation is granted; 4° Indicates the…

I.-The maximum value of the period referred to in 1° of II of Article L. 5121-12 is set at two years from the date on which the authorisation referred to in this Article is granted. II.-The maximum value of the period mentioned in III of Article L. 5121-12 is set at one year from the date of granting of the early access authorisation mentioned in this article, renewable, where applicable,…

I.-The early access authorisation may be renewed. Renewal is the subject of an application by the holder of this authorisation addressed to the Haute Autorité de santé, the ministers responsible for health and social security and, for applications relating to a medicinal product mentioned in 1° of II of Article L. 5121-12, to the Agence nationale de sécurité du médicament et des produits de santé, with the exception of renewals…