The ATU process is an exceptional procedure making available medicinal products that have not yet been granted a marketing authorisation or that are not yet commercialised in France. The aim of ATUs is to provide early access to new promising treatments where a genuine public health need exists.
There are two types of ATU:
- Named patient ATU: issued for a single named patient, at the request of and under the responsibility of the prescribing physician. This type of ATU concerns medicinal products presumed to be effective, and to have an acceptable drug safety profile in the light of the data available.
- Cohort ATU: concerns a group or sub-group of patients, treated and monitored according to criteria fully defined in a protocol for therapeutic use. It is issued at the request of the holder of the licensing rights, which must commit to submit a marketing authorisation application within a determined period. This type of ATU concerns medicinal products strongly presumed to be effective and to have an acceptable safety profile, having reached an advanced stage of development, for example with a marketing authorisation dossier currently being compiled or registered.