Section 7: Early access authorisations

I.-At the request of the holder of the exploitation rights, the Haute Autorité de santé may modify any early access authorisation mentioned in article L. 5121-12 or the therapeutic use and data collection protocol. Where applicable, this decision is taken after receiving the assent of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) with regard…

I.-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…

When the authorisation is suspended, withdrawn or not renewed, or when a decision to modify the authorisation makes this necessary, the holder of the early access authorisation referred to in Article L. 5121-12 will take all necessary steps, in particular with stockholders, to stop distributing the medicinal product. If this measure is not taken within a timeframe compatible with the interests of public health, the Agence nationale de sécurité du…