French Public Health Code
In forceI.- 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 produits de santé immediately informs the holder of the compassionate access rights.Upon receipt of a first application for compassionate access authorisation for a medicinal product in a specific indication, the Director General of the Agence nationale de sécurité du médicament et des produits de santé will immediately inform the holder of the exploitation rights for the medicinal product concerned or his authorised representative and ask him to forward by any means giving a date certain of receipt :
1° Any information relating to the efficacy, safety, manufacture and control of the medicinal product and any information relevant to the examination of the application;
2° Any information relating to the titles and objectives of any research involving the human person for commercial purposes, including any clinical trials, planned or in progress for the medicinal product concerned, with, where appropriate, their progress, as well as, for those conducted in France, information relating to the identity of all the investigators and the designation of the site or sites concerned;
3° A copy of any marketing authorisation issued in another State for the medicinal product concerned;
4° A draft protocol for therapeutic use and follow-up of patients treated;
5° Where research involving the human person, including clinical trials, is being carried out for commercial purposes in the indication in question, an undertaking by the holder of the exploitation rights or his authorised representative to submit, within a period set by decree, an application for the early access authorisation referred to in Article L. 5121-12 for the medicinal product concerned in the indication in question.
III.-When the application for authorisation for compassionate access concerns the treatment of a rare disease, the Director General of the Agency will seek the opinion of the centres of reference and centres of competence in charge of the rare diseases concerned on the condition relating to the presumed efficacy and safety of the medicinal product.
IV.If the Director of the Agency identifies, for the medicinal product, research involving the human person mentioned in 1° or 2° of Article L. 1121-1, including a clinical trial mentioned in Article L. 1124-1, in progress for commercial purposes in the indication concerned, it shall request an undertaking from the holder of the exploitation rights or its authorised representative to submit, within the time limit specified by decree, an application for the early access authorisation mentioned in Article L. 5121-12 for the medicinal product concerned in the indication concerned, unless this undertaking has been forwarded in application of II. The holder of the exploitation rights or its authorised representative has a maximum period of one month from the date of receipt of the request from the Director of the Agency to inform the Agency of its decision. If no undertaking is sent within this period, the application for authorisation of compassionate access is declared inadmissible.
