Compassionate access to a drug without MA in exceptional cases
Compassionate Access (AC) refers to the exceptional use of a medicine that has not yet obtained marketing authorisation.
It is intended for patients with severe conditions and no alternative treatment options.
This procedure ensures timely medical response under the supervision of the health authority, with rigorous patient and treatment monitoring.
Its objective is to balance urgent therapeutic needs with safety requirements, offering access to innovative solutions when no other options are available.
