ISI / Mandatory statements on Interactive Paper

Interactive Paper is trusted by leading global pharmaceutical brands, including Pfizer, Eli Lilly, Sobi, Biogen, GSK, Novartis, Merck, MSD, and many others, to deliver compliant and impactful marketing solutions
Important Safety Information (ISI) is mandatory regulatory-approved text accompanying pharmaceutical marketing materials, especially for drugs with Boxed Warnings. ISI clearly communicates essential risks, side effects, contraindications, and detailed prescribing information to ensure compliance and patient safety.
Interactive Paper serves clients globally, with compliance requirements varying by region:
  • USA: ISI must follow FDA regulations, requiring explicit safety disclosures.
  • Europe: Compliance adheres to EMA guidelines, often using Summary of Product Characteristics (SmPC).
  • Canada: ISI aligns with Health Canada regulations, requiring clear bilingual safety disclosures.
  • Other Regions: Requirements vary widely based on local regulatory agencies.
Innovative ways to incorporate ISI without overwhelming the primary engagement content include:
  • Digital Integration (NFC/QR): ISI accessible digitally via QR codes or NFC technology embedded into Interactive Paper, optimizing printed space.
  • Digital Pop-ups: Interactive Paper can activate digital pop-up disclaimers, ensuring user acknowledgment of ISI before accessing further content.
  • Direct Printing: ISI printed directly onto the backside of Interactive Paper, efficiently utilizing available space.
  • Folder Card Attachment: ISI presented on a separate folder card housing the Interactive Paper, clearly visible without obstructing main content.

Examples & Video Demonstrations:

Explore these creative solutions for compliance, enhancing engagement and regulatory adherence in your campaigns.