Quality & complianceOfficial

AIFA clarifies how bibliographic sources should be used in medicine promotional materials

🇮🇹 AIFA · Tue 10 Nov 2026

Italy's medicines agency has published a document for companies on referencing bibliographic sources in promotional materials, via its Office for Medicines Information and Advertising Oversight.

The Italian Medicines Agency (AIFA) has published a document clarifying how companies should use bibliographic sources in promotional materials for medicinal products. The item is dated 10 November 2026.

The document comes from AIFA's Office for Medicines Information and Advertising Oversight (UIMVP), the unit responsible for oversight of medicines information and advertising. It is addressed to companies that produce and distribute promotional materials.

The full text of the document was not available at the time of writing, so details of the specific requirements, examples or any transition arrangements cannot be reported here. The publication indicates, however, how AIFA expects promotional claims to be supported and referenced.

As general context, promotional claims for medicines in the EU must be accurate, up to date and consistent with the approved product information, and companies are expected to be able to substantiate them. How references are presented is therefore a routine focus of compliance review.

What it means for your team

  • Regulatory and compliance teams handling Italian promotional materials should obtain the UIMVP document from AIFA and check it against current referencing practices.
  • Medical and promotional review procedures may need to be checked to confirm that cited sources are used and presented in line with AIFA's clarifications.
  • QA and PV staff involved in approving materials should note that the document signals AIFA's expectations on how claims are referenced, even though the full details were not reviewed for this report.

Official source: AIFA ↗

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

More Quality & compliance All →