RegulatoryOfficial

AIFA extends temporary authorisation for patch-test haptens by 36 months

🇮🇹 AIFA · Tue 10 Nov 2026

Italy's medicines agency has pushed back the 16 November 2026 deadline for haptens lacking commercial clinical alternatives, keeping them available for allergy diagnosis.

The Italian Medicines Agency (AIFA) has published Decision DTS No. 60/2026, dated 5 November 2026, extending by a further 36 months the temporary authorisation for haptens used in patch testing where no clinical alternatives are commercially available. The agency posted its notice on 10 November 2026.

The extension moves the deadline of 16 November 2026 set in Article 1(1) of Director General Decision No. 442 of 13 November 2023. That earlier decision had renewed the transitional authorisation for these products.

Annex 1, revision 3, forms part of the new decision and lists every hapten authorised for clinical use. Entries fall into three groups: those holding a marketing authorisation (AIC), those authorised for marketing ope legis, and those authorised on a transitional basis under the new decision because no alternative is on the market.

For each hapten, column 3 of the annex gives the formulation currently recommended on available knowledge, which is also published in the Series updated by the AIFA Technical Table. For haptens not covered by those Series, the formulations in columns 4 and 5 are permitted. The decision is published in the Gazzetta Ufficiale of the Italian Republic and took effect on the same date.

What it means for your team

  • Companies and clinicians relying on transitionally authorised haptens face no supply gap from the 16 November 2026 expiry, as the authorisation now runs 36 months further.
  • Regulatory teams should check Annex 1 rev. 3 to confirm whether each hapten holds an AIC, is authorised ope legis, or is covered only by the transitional route.
  • Quality and labelling teams should compare their formulations with column 3 and the AIFA Technical Table Series, or with columns 4 and 5 for haptens outside those Series.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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