Snapshot

The Autorisation Temporaire d’Utilisation (Temporary Use Authorization) pathway has been developed by the National Agency for the Safety of Medicines and Health Products of France.

This pathway can be used where I. - Articles L. 5121-8 and L. 5121-9-1 do not preclude the use, exceptionally, of certain drugs, in specific therapeutic indications, intended to treat serious or rare diseases, in the absence of appropriate treatment, when the implementation of the treatment cannot be postponed and one of the following conditions is met: 1 ° The efficacy and safety of these drugs are strongly presumed in view of the results of therapeutic trials carried out with a view to an application for marketing authorization which has been filed or which the company interested party undertakes to deposit within a determined period, the maximum value of which is fixed by decree; 2 ° These medicinal products, if applicable imported, are prescribed, under the responsibility of a doctor, to a patient named by name and who cannot participate in research involving humans when they are likely to have clinically relevant efficacy. and an important effect for him, that serious consequences for this patient are highly probable given the state of the available therapies and that their efficacy and safety are strongly presumed in the state of scientific knowledge. The prescribing doctor must justify that the patient, his legal representative if he is a minor, as well as the person in charge of the protective measure if he is an adult subject to a legal protection measure with representation relating to the person or the person of trust that he has appointed pursuant to Article L. 1111-6 has received information adapted to his situation on the absence of a therapeutic alternative, the risks, constraints and the benefit likely to be provided by the drug. The procedure followed is recorded in the medical file..

It is an abridged review (a reliance pathway).

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