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Agenzia Italiana del Farmaco
Renewal of the provisional authorisation to use haptens for patch tests in the absence of commercially-available clinical alternatives - Renewal of the provisional authorisation to use haptens for patch tests in the absence of commercially-available clinical alternatives
Renewal of the provisional authorisation to use haptens for patch tests in the absence of commercially-available clinical alternatives
AIFA has published its Director-General Decision DG 442/2023 of 13 November 2023 (GU Serie Generale n.268, 16-11-2023) which renews the authorization to use haptens for patch tests that have not yet been authorized with an MA or that are not authorized for sale ope legis, on an exceptional basis and in the absence of clinical alternatives.
The list of aptens is reported in the Annex to the Decision and companies interested in marketing are required to inform the Agency and to submit a MA application within 36 months from the date of effectiveness of the Decision.
Please note that the Annex will be regularly updated taking into account the revision work carried out by the AIFA Working Group on clinical use of haptens or following production changes that impact their availability of the products.
Published on: 27 November 2023
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