The Italian Medicines Agency (AIFA) is working on the regulation of allergens.

Ope legis allergens are products marketed without any marketing authorization (MA) in compliance with Ministerial Decree of 13 December 1991, that allowed products already used in Italy before 1 October 1991 to remain on the market until they were granted a regular MA. The assessment of the ope legis allergen dossier is ongoing in order to grant a marketing authorization.

To avoid unavailability of haptens for patch testing, AIFA published Decision 1334/2021 updated by Decision 98/2022.

Taking into account the above-mentioned Decisions, AIFA admitted a list of haptens to clinical use for a period of 24 months. This Temporary authorization to clinical use applies only to haptens that meet the following requirements:

• They should not be included in the 1991 Ope Legis List (Attachment 1 available here);
• They should not have a marketing authorization in Italy;
• They should be included in the list attached to Decision 98/2022;
• They should be manufactured in a European GMP facility in compliance with GMP rules (authorization provided);
• The company intending to market haptens according to Decision 98/2022 should submit a formal notification to AIFA (protocollo@pec.aifa.gov.it to the attention of the Medicinal Products Authorization Division) with the list of haptens to be marketed and the GMP authorization.