Swissmedic has announced a significant change in packaging requirements for certain veterinary medicinal products. Starting January 1, 2026, it will be permissible to replace the paper leaflet in product packaging with alternative formats under specific conditions. This change aims to streamline how vital information is delivered to veterinary professionals and end-users, improving accessibility and reducing environmental impact.
What changed?
Effective January 1, 2026, Swissmedic will allow manufacturers of certain veterinary medicinal products to dispense with paper package leaflets. Instead, electronic or alternative formats for providing product information may be used. This revision reflects Swissmedic’s commitment to modernizing regulatory practices while maintaining the safety and usability of veterinary medicines.
Why does it matter?
This change offers several benefits. It reduces reliance on physical materials, resulting in potential cost savings and lower environmental impact. It also enhances end-user convenience through digital accessibility, provided regulated systems ensure users retain easy access to essential medical information.
Who is affected?
The update affects manufacturers, veterinarians, and distributors of veterinary medicines. The regulatory teams overseeing product compliance should also prepare for amendments to documentation and approval flows. Clear internal communication of these changes will be critical for organizational readiness.
Frequently Asked Questions
1. Will all veterinary products qualify for this exemption?
No, only products meeting specific criteria outlined by Swissmedic will qualify. Manufacturers must ensure the digital alternatives comply with accessibility, regulatory, and safety standards.
2. How will users access the digital leaflet?
Information is expected to be hosted on easily accessible platforms, with clear guidance for end users about where and how to access it.
3. Are there environmental motivations behind this change?
Yes, transitioning to digital alternatives helps reduce paper waste. This initiative aligns with broader sustainability goals in regulatory practices.
Conclusion
Swissmedic’s decision to allow alternatives to paper leaflets for veterinary medicinal products signals a progressive step in regulatory alignment with modern standards. Veterinary medicine manufacturers and regulatory teams should adapt their workflows to ensure compliance ahead of the January 2026 implementation date.
Disclaimer
This information is intended for clinical, quality, and regulatory professionals. It is not legal advice. Always consult official documentation or legal counsel for compliance guidance.
Mandatory Swissmedic Link
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/tierarzneimittel/information/eleaflet-tam.html