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AIFA fixes company-level 2025 direct-purchase spending payback in determination 1531/2026

🇮🇹 AIFA · Thu 29 Oct 2026

Italy's medicines agency has assigned each marketing authorisation holder's 2025 payback share for direct purchases, with no changes made after consulting companies and payment due within 30 days of effectiveness.

The Italian Medicines Agency (AIFA) has adopted determination no. 1531/2026, which sets the individual payback shares owed by each marketing authorisation holder for pharmaceutical spending on direct purchases in 2025. The amounts are split by region and autonomous province, in line with Article 1, paragraph 580 of Law no. 145 of 2018.

The determination follows a consultation with pharmaceutical companies held in previous months. AIFA says the observations received led to no changes, so the payback burdens and the market shares by SIS code remain as originally calculated.

The determination and its annexes take effect the day after a notice is published in the Gazzetta Ufficiale of the Italian Republic. Companies can consult their market shares and payback figures in the 2025 payback section of AIFA's Spending-Pha platform, using their own credentials.

Companies liable for payback must pay within 30 days of the determination taking effect. Payments go to the individual regions according to the split in Annex C, using the regional bank accounts listed in Annex H. The payment reference must read "Det. AIFA- Ripiano spesa 2025" and give the debtor company's SIS code.

AIFA asks companies to make a separate transfer for each SIS code they hold, as shown in Annex C, and not to combine several codes in one payment. Payment must be reported to the agency within three working days, by uploading the payment receipts to Spending-Pha and sending proof of payment to AIFA's certified email address with a prescribed subject line.

What it means for your team

  • Market-access and finance teams should check their company's allocated amounts per SIS code and region in Spending-Pha and Annex C.
  • The 30-day payment window runs from the date the determination takes effect, which depends on the Gazzetta Ufficiale notice, so cash planning should track that publication.
  • Payment operations need one transfer per SIS code, the specified reference wording, and confirmation to AIFA within three working days.

Official source: AIFA ↗

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

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