Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its packaging guidance for human medicinal products. Medicinal products intended exclusively for healthcare professionals no longer require a printed package leaflet as part of their packaging. This update is particularly relevant for clinical, quality, and regulatory professionals managing compliance and product distribution within these frameworks.
What changed?
Swissmedic’s updated guidance allows for a waiver of the printed package leaflet for medicinal products intended solely for healthcare professional use. This rule applies where such information may be accessed digitally or through existing professional communication channels. The leaflet, traditionally included in packaging, serves as a key source of drug information, including indications, contraindications, dosages, and warnings. Moving forward, healthcare-specific medicinal products can be distributed without this physical document, provided digital or alternative means of access are ensured.
Who is affected?
The new guidelines specifically impact manufacturers and distributors of medicinal products designed for exclusive use within healthcare settings. Key stakeholders include regulatory affairs teams, compliance officers, and medical supply chain managers. Healthcare institutions may also be required to adapt their information distribution practices to align with these updates.
Patients are unlikely to be directly affected, as this change applies strictly to healthcare-administered medicines. Professionals should ensure they maintain uninterrupted availability of critical medicinal product data through approved platforms.
Why was this change made?
The decision by Swissmedic to permit the removal of printed package leaflets stems from advancements in digital communication and the need to streamline packaging processes for professionally administered medicines. The approach balances regulatory compliance with practicality, responding to growing trends in digital accessibility within healthcare. This may also reduce environmental waste associated with printed materials.
Additionally, transitioning to digital or alternative communication methods can enhance real-time access to the most up-to-date drug information. Such measures aim to improve efficiency while maintaining product safety and performance standards in compliance with MDR Annex XIV principles.
FAQ
1. What if the medicines are repurposed for patient use?
The updated guidance applies strictly to products for professional use. Any repurposing or reclassification of products may require updated packaging materials, including reinstating printed leaflets, to meet patient information regulations.
2. How will healthcare providers access the necessary information?
Healthcare professionals will rely on electronic resources, official documentation portals, or other approved channels to access product information. Manufacturers must ensure this information remains accessible and compliant.
3. Are there penalties for failing to comply?
Compliance is mandatory under Swissmedic’s guidance. Non-compliance may result in regulatory actions, including product recalls, fines, or distribution suspension.
4. How should manufacturers prepare for this change?
Manufacturers should establish electronic alternatives for providing product information. This could involve creating secure, user-friendly platforms or collaborating with healthcare institutions to facilitate data sharing.
Conclusion
The removal of printed leaflets for medicinal products used solely in healthcare settings marks a significant modernization of Swissmedic’s regulatory framework. By embracing digital communication, manufacturers have the opportunity to enhance information delivery while contributing to sustainability goals. It is essential for stakeholders to familiarize themselves with and adapt to these changes to maintain regulatory compliance and operational efficiency.
Disclaimer
This article is intended for informational purposes only and should not be construed as legal advice. Readers are advised to consult with regulatory experts or legal professionals for specific compliance guidance.
Swissmedic Reference
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-packmittel-ham.html