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04.09.2025

Swissmedic Journal

Latest edition
Swissmedic Journal August 2025

02.09.2025

Wissenschaftliche/r Mitarbeiter/in Medical Devices Vigilance (80-90%)

Job advertisement | Division Medical Devices Vigilance

02.09.2025

HPC – Erratum zur DHPC zu Tegretol 2% (Propylenglykol)

Zusätzliche Vorsichtsmassnahmen bei Neugeborenen

02.09.2025

Summary report on authorisation – NEXPOVIO®

First authorisation

01.09.2025

Disposal information to be added to Patient information

Change to the Guidance document Product information for human medicinal products

01.09.2025

Revision of the guidance document Formal requirements

Swissmedic has revised the guidance document Formal requirements accordingly, and this will enter into force on 1 September 2025

01.09.2025

Changes to the guidance document Time limits for authorisation applications

Shortening of time limits for applications for new authorisation of medicinal products with known active substances without innovation under Art. 13 TPA

01.09.2025

Swiss Good Practices for the Reprocessing of Flexible, Thermolabile Endoscopes

The Swiss Good Practices for the Reprocessing of Flexible, Thermolabile Endoscopes (GPAE) are here! The central reference document for the reprocessing of flexible endoscopes in inpatient and outpatient healthcare facilities has been published in September 2025. It is now available in German and French.

01.09.2025

Duration of contraception following the end of treatment with medicinal products with genotoxic potential

Swissmedic requests marketing authorisation holders to review their medicinal products with genotoxic potential

01.09.2025

Revision of the guidance document "Renewal and discontinuation of authorisation or change of status (main authorisation / export licence)"

Swissmedic clarifies the requirements for the renewal and change of status of medicinal product authorisations

29.08.2025

DHPC – Urapidil Stragen i.v. (urapidilum)

Schwierigkeit beim Öffnen / Brechen bestimmter Ampullen
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