French Public Health Code
In forceI.-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 granted under the conditions mentioned in III of Article R. 5121-72.
II.- The application for renewal is addressed in accordance with the procedures defined in I of Article R 5121-68 no later than three months before the expiry date of the authorisation.Applications for renewal must be submitted in accordance with the procedures defined in I of article R 5121-68 no later than three months before the expiry date of the authorisation. This application must be accompanied by the updated information mentioned in article R. 5121-68 as well as any information obtained during the previous authorisation period on the medicinal product in question, in particular the periodic summary report, and the consequences of its use.
III. -The examination of the application and the conditions under which the decision to grant early access authorisation is taken, as defined in III and IV of article R. 5121-68 and in articles R. 5121-69 and R. 5121-69-1, are applicable to decisions concerning the renewal of this access.
The previous authorisation remains in force until the Haute Autorité de santé has taken a decision on the application for renewal and at the latest until the expiry date of the period provided for in 1° of I of Article R. 5121-69-2, possibly extended by the periods provided for in IV of Article R. 5121-68, in I of Article R. 5121-69 and in Article R. 5121-69-1.
IV. - The Haute Autorité de santé refuses to renew the authorisation.The Haute Autorité de Santé will refuse renewal of the early access authorisation if the conditions set out in article L. 5121-12 are not met, if the obligations set out in this article are not complied with or for any other public health reason, in accordance with the same procedures as those set out in article R. 5121-69.
V.-In the event of a decision by the Haute Autorité de santé refusing to renew the early access authorisation, this authorisation is consequently deemed to have been withdrawn.
