French Public Health Code
In forceI.-The Haute Autorité de santé may, on its own initiative or at the request of the ministers responsible for health and social security, suspend or withdraw an early access authorisation when one of the conditions set out in I and II of article L. 5121-12 is no longer met or for any of the reasons mentioned in 3° of VI of the same article.
II.-When the holder of the exploitation rights wishes to obtain the withdrawal of its early access authorisation, it must submit a request to the Haute Autorité de santé. In this case, the Haute Autorité will withdraw the authorisation it has issued, without prejudice to the provisions of articles L. 162-16-5-1, L. 162-16-5-1-1, L. 162-16-5-4 and L. 162-18 of the Social Security Code, within one month of acknowledgement of receipt of the request.
If the Haute Autorité de santé does not respond within this period, the request for withdrawal is deemed to have been accepted.
III.In an emergency, the Agence nationale de sécurité du médicament et des produits de santé may temporarily suspend an early access authorisation for one of the reasons provided for in 3° of VI of Article L. 5121-12.
IV. -Except in emergencies, suspension or withdrawal may only take place after the holder of the authorisation has been invited to provide its observations.
Any decision to withdraw or suspend an authorisation is notified to the holder of the rights to use the medicinal product and a copy is sent to the Ministers for Health and Social Security and, where applicable, to the Agence nationale de sécurité du médicament et des produits de santé or the Haute Autorité de santé.
V.-Decisions to suspend or withdraw authorisation must state the reasons on which they are based and indicate the appeal procedures and deadlines.
Suspension may not exceed three months.
VI.-By way of derogation from I, IV and V, when the condition mentioned in 2° of II of article L. 5121-12 relating to the non-inclusion of the medicinal product on one of the lists mentioned in the first paragraph of article L. 5123-2 of the present code or in the first paragraph of article L. 162-17 of the Social Security Code in the indication in question is no longer met, the early access authorisation is automatically terminated with effect from the date of inclusion of the medicinal product in the indication in question on one of these lists without the Haute Autorité de Santé needing to take a decision to this effect.
VII -Any decision concerning an early access authorisation which has been suspended under III by the Agence nationale de sécurité du médicament et des produits de santé may only be taken by the Haute Autorité de santé after receiving the assent of the agency.
