On November 26, 2025, Swissmedic announced the temporary approval for distribution of NaCl 0.9% infusion solution from B. Braun in foreign packaging, specifically Scandinavian labeling. This authorization is aimed at addressing supply shortages affecting healthcare facilities in Switzerland. Clinical, quality, and regulatory teams should note the regulatory implications, as temporary measures are often subject to stricter monitoring and conditions.
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What changed?
Swissmedic has granted a temporary authorization for the sale of B. Braun’s NaCl 0.9% infusion solution in Scandinavian packaging. This decision comes in response to supply issues that have impacted Swiss healthcare providers reliant on this essential product. The temporary nature of this authorization implies that it is a short-term solution under specific conditions.
Who is affected?
This development directly impacts clinical teams, hospitals, and pharmacies that utilize NaCl 0.9% infusion solutions in Switzerland. Quality assurance teams must ensure the foreign packaging meets compatibility standards and aligns with local regulations. Regulatory committees overseeing imported medical solutions should carefully review these temporary allowances.
Regulatory background
Swissmedic’s decision reflects their role in addressing immediate medicinal needs while adhering to safety and performance principles. Under MDR Annex XIV considerations, any temporary approvals for foreign-packaged medical products are required to ensure equivalent safety levels and efficacy. Importers and distributors must also adhere to storage, transport, and labeling provisions to minimize risks.
B. Braun is the manufacturer behind the NaCl 0.9% infusion product, which has been globally recognized for its performance reliability. Swissmedic’s temporary approval may serve as a precedent for similar shortage situations involving international packaging.
FAQ
1. Why is foreign packaging being permitted?
Foreign packaging from Scandinavian markets was approved to address an immediate supply shortage that could affect patient care in Switzerland.
2. Are there risks to using foreign-labeled medical products?
Swissmedic has ensured that safety and efficacy remain uncompromised despite the change in packaging format. Healthcare professionals should review labeling carefully for any critical differences.
3. How long is the temporary authorization valid?
The exact duration of this approval was not disclosed. Regular updates from Swissmedic are expected to define timelines.
4. What steps should quality teams take?
Teams should reevaluate procedures for storage, compliance verification, and compatibility testing of the foreign-labeled product.
Conclusion
Healthcare stakeholders in Switzerland are advised to incorporate this temporary regulatory adjustment into their processes. Swissmedic’s decision underscores the importance of adaptability in addressing urgent shortages, while still maintaining high safety and performance standards. Regular updates on the situation should be closely monitored.
Disclaimer
This article is for informational purposes only and does not constitute legal or regulatory advice. Healthcare facilities and teams must consult the official Swissmedic guidelines to ensure compliance.
Swissmedic Information
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-nacl-b-braun-injlsg.html