Quality & complianceOfficial

AIFA publishes clarifications on bibliographic sources in medicines promotional materials

🇮🇹 AIFA · Tue 10 Nov 2026

Italy's medicines agency has issued a document from its advertising oversight office setting out how companies should use bibliographic references in promotional materials for medicinal products.

The Italian Medicines Agency (AIFA) published a document on 10 November 2026 clarifying the use of bibliographic sources in promotional materials for medicinal products. The text was drafted by the agency's Office for Medicines Information and Advertising Oversight (UIMVP).

According to AIFA, the aim is to give companies clarifications on how bibliographic sources should be used within promotional materials. The agency's web notice does not set out the detail of those clarifications; they are contained in an accompanying PDF of about 0.39 MB, which was not reproduced in the material reviewed for this report.

The publication signals the expectations of the office that oversees medicines advertising in Italy on how promotional claims are referenced and substantiated. Companies that rely on internal review and approval workflows for promotional items may wish to read the full document to see whether those procedures need adjusting.

As general context, promotional materials for medicines are subject to national advertising rules that require claims to be accurate and verifiable, which is why the quality and traceability of cited sources are a recurring focus for regulators.

What it means for your team

  • Obtain and read the full UIMVP PDF, as the web notice gives only the purpose of the document and not its content.
  • Check whether your Italian promotional material review and approval SOPs cover how references are selected, cited and verified.
  • Regulatory and medical-review teams should consider whether existing materials in circulation in Italy are consistent with the clarified expectations once the detail is confirmed.

Official source: AIFA ↗

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

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