Subsection 2: Authorisation procedure

I. – The application for authorisation or renewal of authorisation of an establishment or organisation to carry out the activities referred to in Article R. 4211-32 relating to advanced therapy medicinal products prepared on an ad hoc basis is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by the legal entity applying for this authorisation, and by any means enabling…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will send a copy of the complete application to the Director General of the Agence de la biomédecine for his opinion. The Director General of the Agence de la biomédecine will send his opinion to the Director General of the Agence nationale de sécurité du médicament et des produits de santé within two months…

I. – The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within ninety days from the date of receipt of the application accompanied by a file containing all the documents mentioned in the decision provided for in Article R. 4211-34. The Director General may request any additional information or carry out an investigation to enable him…