On December 17, 2025, Swissmedic approved a temporary measure allowing the distribution of Hibidil sterile solution in French-language packaging within Switzerland. This solution was implemented to address an ongoing stock issue and ensure continued supply for medical needs. Healthcare professionals, regulatory teams, and quality managers should familiarize themselves with these updates.
What changed?
Swissmedic has granted a time-limited authorization permitting the sale of Hibidil sterile solution in French packaging. This decision accommodates a critical out-of-stock situation for this medical product in Switzerland.
Hibidil is typically distributed in standard Swiss-compliant packaging. Due to supply disruptions, Swissmedic enacted this temporary measure to maintain product availability in the Swiss healthcare system. Although the packaging is in French, the product composition and safety profile remain consistent with the previously approved version.
Who is affected?
This update is significant for professionals involved in clinical care, pharmacy operations, and regulatory compliance. Healthcare providers should be aware of the changes in labeling and ensure patients receive the necessary information. Pharmacists may need to adjust their workflows to accommodate these temporarily approved materials.
Additionally, quality managers must ensure alignment with internal protocols to meet regulatory and operational requirements under the temporary authorization. It is crucial for all stakeholders to understand the details of this transition to avoid any miscommunication.
What is the regulatory background?
Swissmedic, the Swiss regulatory authority for therapeutic products, oversees decisions to ensure public health safety and pharmaceutical supply continuity. Temporary packaging approvals—like the one granted for Hibidil sterile solution—occur under stringent evaluation processes.
Such authorizations are usually limited in scope and are monitored to ensure compliance with national standards. Swissmedic may require corrective action or further reviews depending on the duration of the stock shortage and associated risks. Professionals managing the integration of this product should remain vigilant about applying local regulatory guidelines during this temporary phase.
Key regulatory considerations
- Ensure documentation for the French packaging complies with Swissmedic-approved standards.
- Verify batch consistency and labeling alignment with Swiss regulatory expectations.
- Provide clear guidance to end users and healthcare professionals on packaging language differences.
FAQ
A1. This measure responds to a stock shortage, enabling continued availability of the product in Switzerland.
A2. No. The composition and safety profile remain unchanged. Only the packaging language differs temporarily.
A3. Swissmedic has not provided a definitive timeline, as temporary measures depend on the resolution of stock challenges.
Conclusion
Swissmedic’s temporary approval for Hibidil sterile solution in French packaging highlights its commitment to resolving supply chain challenges while maintaining public safety. Healthcare and regulatory teams must ensure smooth implementation by reviewing their compliance procedures and communicating changes effectively.
Disclaimer
The details in this article are informational and intended for professionals. They are not legal or regulatory advice. Always consult official Swissmedic documentation for compliance requirements.
Swissmedic Announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/out-of-stock/approved-applications/out-of-stock-hibidil-sterile-loesung.html