The ATU scheme has been replaced by the AAC in 2021.
ATU is a regulatory procedure under which the French Medicines Agency (ANSM) may authorize, in exceptional circumstances and on a case-by-case basis, the use of a medicinal product that has not yet been authorized in France.
This procedure is intended for sick patients who cannot be treated with an authorized medicinal product, and for whom there is no therapeutic alternative.
The ATU procedure does not allow a medicinal product to be marketed in France. It only allows its use under specific conditions and for a limited period of time.
The ATU procedure is only possible if the following conditions are met:
– There is no authorized medicinal product that can treat the patient’s condition;
– There is no therapeutic alternative;
– The patient’s condition is serious or life-threatening;
– The expected benefits of using the medicinal product outweigh the risks.
If these conditions are met, the ANSM may issue a temporary authorization for use of the medicinal product in question. This authorization is valid for one year and may be renewed.
The ATU procedure is overseen by a committee of experts, which assesses the applications and makes recommendations to the ANSM.
The ANSM may also issue an ATU in response to a request from a healthcare professional. In this case, the ANSM assesses the application and makes a decision within 30 days.