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AIFA fixes company payback shares for 2025 Italian direct-purchase drug overspend

🇮🇹 AIFA · Thu 29 Oct 2026

Determination 1531/2026 assigns each marketing authorisation holder's payback burden, by region, with no changes after consultation; payment falls due 30 days after the determination takes effect.

The Italian Medicines Agency (AIFA) has adopted Determination No. 1531/2026, which allocates the individual payback shares for 2025 pharmaceutical spending on direct purchases. The shares are assigned to each marketing authorisation holder and split by region and autonomous province, under Article 1, paragraph 580 of Law No. 145 of 2018. AIFA announced the measure on 29 October 2026.

The determination follows the consultation with companies held in previous months. AIFA says that, in light of the observations received, it made no changes. Payback burdens and the market shares by SIS code therefore remain as previously set.

The determination and its annexes take effect the day after a notice is published in the Gazzetta Ufficiale della Repubblica Italiana. Companies liable for payback must pay within 30 days of that effective date. Figures on market shares and payback amounts can be viewed in the 2025 payback section of the Spending-Pha platform, using company credentials.

Payments go to the individual regions according to the split in Annex C, via the regional bank accounts listed in Annex H. The payment reference must read "Det. AIFA- Ripiano spesa 2025" and include the SIS code of the debtor company. Each SIS code requires a separate transfer, and AIFA asks companies not to make cumulative payments covering several codes.

Companies must report payment to AIFA within three working days. They should upload the payment slips to the Spending-Pha online service and send proof of payment to AIFA's certified email address, protocollo@pec.aifa.gov.it. The subject line must follow the format: UGSF/ Procedimento ripiano anno 2025 NomeAzienda CodiceSIS Attestazione Pagamento.

What it means for your team

  • Finance and market-access teams should check their company's SIS-code payback amounts and regional splits in Spending-Pha and Annex C, as AIFA has left the figures unchanged after consultation.
  • The 30-day payment clock runs from the determination's effective date, which depends on the Gazzetta Ufficiale notice, so teams should track that publication.
  • Payments need separate transfers per SIS code, to regional accounts in Annex H, with the prescribed reference text.
  • Proof of payment must be registered on Spending-Pha and emailed to AIFA within three working days, using the prescribed subject line.

Official source: AIFA ↗

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

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