Insights

On September 9, 2025, the Italian Medicines Agency (AIFA) released the updated version of the Domande & Risposte (D&R) IMS document, now available on its official website. This update represents another important step in AIFA’s effort to harmonize the interpretation of regulatory requirements concerning scientific information and promotional materials for medicinal products. Compared to the previous editions, the 2025 version provides clearer instructions and renewed attention to transparency, readability, and compliance with digital and print standards.

Among the main updates, AIFA introduces new clarifications on several key aspects:

• Use of QR codes: in both printed and digital materials te QR code can now be used not only for including the Summary of Product Characteristics but also to link other promotional materials already authorized by AIFA. In digital materials, the QR code linking to the RCP, when present, must be clearly visible and clickable on the first page.
• Commercial information and deposit code: this information must appear in a minimum font size of 9 points (Times New Roman), with at least 3 mm of line spacing, and should be placed either on the first page of the promotional material or next to the product image, if included.
• deposit code: must appear immediately next to the deposit date; it is not acceptable for information to be displayed in a way that requires the reader to rotate the page or enlarge the text to read it properly.
• Mandatory statement on adverse reaction reporting: all materials must include the following wording: “Healthcare professionals are required to report any suspected adverse reaction through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse ”

Overall, the D&R IMS 2025 update confirms AIFA’s ongoing commitment to promoting clarity, accessibility, and regulatory consistency in the communication of medicinal product information. By strengthening formal and visual requirements and adapting to digital practices, AIFA continues to guide companies toward more transparent and responsible scientific communication, ensuring compliance and trust across all promotional channels.

RPN is ready to support pharmaceutical companies in this evolving regulatory landscape — from the review and adaptation of promotional materials to ensure compliance with AIFA’s latest guidelines, to the continuous monitoring of regulatory updates and strategic advice to maintain full alignment with current standards.

For more information contact us at info@rpngroup.com