AIFA has published its Director-General Decision DG 34/2024 of 8 February 2024 (GU Serie Generale n. 45 23-02-2024) which updates the Annex 1 of AIFA’s Director-General Decision DG 442/2023 - Renewal of the provisional authorisation to use haptens for patch tests that have not yet been authorized with a MA or that are not authorized for sale ope legis, on an exceptional basis and in the absence of clinical alternatives.

It should be noted that future updates to this Annex will be published in a press release on the AIFA institutional website and will be effective from the date of publication.

It should be noted that the Director-General Decision allows the marketing only of individual haptens produced in GMP, without equivalents with MA or authorized for trade by law, and identified with the unique code reported in the Annex 1. Haptens with number codes other than those indicated in Annex 1 are not authorized for marketing.

For further clarity:
The SmartPractice company can market

• haptens for which it has obtained the MA
• haptens authorized to trade by law
• haptens produced in GMP identified by a specific code reported in Annex 1.

The Chemotechnique MB Diagnostics company is authorized by the Swedish Medical Products Agency to export to Italy exclusively individual haptens produced in GMP identified by the specific code reported in Annex 1.