Reference is made to the procedure for concluding the transitional phase for the granting of the MA pursuant to AIFA Resolution DG 2130/2017, as amended. The holders of allergen products for immunotherapy not eligible for the procedure because they failed to meet the eligibility criteria defined by the above-mentioned Resolution, were the subject of a rejection decision. However, such rejection decision contained a provision allowing the therapy on going to be completed, in order to ensure the continuity of therapy to patients already in treatment.

Given the time elapsed since the adoption of the mentioned measures, holders of allergen products for immunotherapy who were the subject of the rejection decision, are hereby informed that AIFA will issue a specific provision regarding the end of the therapeutic continuity within six months from the date of publication of this notice on the AIFA’s institutional website. Therefore, from the date indicated in such provision, allergen products for immunotherapy will no longer be marketed for therapeutic continuity purposes.

Similar measures will apply with regard to the products for which holders applied under AIFA Resolution DG 2130/2017, as amended, and then withdrawn.

In conclusion, immunotherapy products contained in the lists referred to as “Annex 2” and “Annex 3” will no longer be marketed for therapeutic continuity.

This notice is given in advance for the benefit of holders, prescribing doctors and local purchasing bodies.