PV Bulletin

Tag archive

Swissmedic

publicSwissmedic · Switzerland · Updated Jun 15, 2026

SEND Format Requirement for New Authorisation Applications in Switzerland

Urgency: High

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Notice
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publicSwissmedic · Switzerland · Updated Jun 5, 2026

Urgent Field Safety Notice (RECALL) - One-Piece Guedel Airways

Urgency: High

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice / Recall
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publicSwissmedic · Switzerland · Updated Jun 19, 2026

Swissmedic Guidance on Injectable Products for Wrinkle Treatment

Urgency: High

Healthcare professionals must report all serious incidents involving injectable devices to Swissmedic as outlined in the new guidance.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Guidance
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