RegulatoryOfficial

AIFA extends transitional 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 using haptens in patch tests where no marketed clinical alternative exists.

The Italian Medicines Agency (AIFA) has published Determina DTS n. 60/2026, dated 5 November 2026, which extends by a further 36 months the deadline of 16 November 2026. That date was set in Article 1(1) of Determina DG n. 442 of 13 November 2023, which renewed on a transitional basis the authorisation to use haptens for patch tests where no clinical alternatives are on the market.

The decision is published in the Gazzetta Ufficiale della Repubblica Italiana and took effect on the same day. AIFA posted the news item on 10 November 2026, days before the earlier deadline was due to expire.

Annex 1, revision 3, forms an integral part of the determination. It lists all haptens authorised for clinical use, whether because they hold a marketing authorisation (AIC), are authorised for marketing ope legis, or are authorised transitionally under the new determination because no clinical alternative is marketed.

For each hapten, column 3 gives the formulation currently recommended on the basis of available knowledge, as published in the series updated by the AIFA Technical Table. For haptens not covered by those series, the formulations in columns 4 and 5 of the annex are permitted.

What it means for your team

  • Companies supplying haptens for patch tests can continue under the transitional regime, with the cut-off moved 36 months beyond 16 November 2026.
  • Regulatory teams should check Annex 1 rev. 3 to confirm whether each hapten is covered by an AIC, ope legis authorisation or the transitional route.
  • Clinicians and suppliers should use the formulations in the annex: column 3 where the AIFA Technical Table series cover the hapten, otherwise columns 4 and 5.

Official source: AIFA ↗

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

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