The ANSM has set up e-saturne, an electronic platform for the submission and processing of
nominal ATUs. As of 1 September, all ATUn request must be provided through e-Saturne
The ATUn – Autorisations Temporaires d’Utilisation nominative (nominal Temporary Authorisation of Use) are issued by the ANSM – Agence Nationale de la Sécurité du Médicament et des produits de la santé (National Agency for Medicines and Health Products Safety) under the following conditions:
- a single named patient
- the drugs under consideration have a presumably favourable efficacy/safety ratio
- the request is made under the responsibility of the prescribing doctor
- the prescription must be based on the repository
The launch follows a switch to online submissions for the HAS process in April.
From 1 September 2019, the e-Saturne platform will be used to submit requests for ATUn. The current fax system will still be available until the 31 December 2019. The application process will be accessible to all health professionals and will simplify and secure exchanges between the various stakeholders (prescribers, pharmacists, ANSM).
The ANSM have published a FAQ and guides for the different users which can be accessed here.