15.05.2025

Swissmedic Vigilance News Edition 34

Late-onset immune-related AEs with immune checkpoint inhibitors | Interstitial lung disease associated with abemaciclib | PML, IRIS and S1PRM: Product Information update | Valproate: Swiss individual case reports of CM and NDD | Statistical review of the activities of the division Safety of Medicines 2024

12.05.2025

Public consultation for ICH Guideline Q1 “Stability Testing of Drug Substances and Drug Products” launched in Switzerland

Swissmedic launches the public consultation on Guideline Q1 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 30 July 2025 for comments

09.05.2025

New version of the form (MIR) for reporting serious incidents

In accordance with the EU publication, this form V7.3.1 will also be mandatory for incidents in Switzerland as of November 2025

09.05.2025

Batch recall – Sondelbay 20 mcg/80 mcl Injektionslösung in einem Fertiginjektor

Rückzug der Charge 8440005 bis auf Stufe Detailhandel

05.05.2025

Out-of-Stock – Thiopental Inresa 0.5 g Pulver zur Herstellung einer Injektionslösung / Infusionslösung

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

05.05.2025

Swissmedic Journal

Latest edition
Swissmedic Journal April 2025

02.05.2025

Finasteride and persistent side effects

Learning from adverse reaction reports – cases from pharmacovigilance

02.05.2025

Swissmedic podcast #5: Focus on veterinary medicine: safety, approval and the environment

Alex Josty interviews Nina Walser, Head of the Veterinary Medicines Department

In focus

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Holidaying in Switzerland

Which medications can be imported into Switzerland in which quantities?
Information on the entry requirements with medicinal products

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Do you have any questions about a particular medicine or a general question about Swissmedic? We’ll be glad to be of assistance. 

Just send an e-mail to questions@swissmedic.ch or use our contact form. Thank you.

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Swissmedic monitors all therapeutic products on the market in Switzerland. Our independent experts ensure the therapeutic products you and your loved ones need are effective, safe and of the highest quality.

What is a medicinal product?

Did you know that tea can also be a medicinal product? But what exactly constitutes a medicinal product and how does it differ from other products? You will find answers to these and other questions in this video.

Delimitation questions in human health

In order for a product to be sold, it must comply with the relevant legal regulations. However, it’s not often immediately apparent which product group it belongs to. In this video, we explain what different categories there are, and when a product is really a therapeutic product – and when it is not!

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01.01.2025

New medical devices regulations

Information concerning the new EU-Regulations as well as their implementation in Switzerland.

Revision of the IvDO and the MedDO
The transitional periods for in vitro diagnostic medical devices have been adapted to the EU Regulation and Swiss labelling simplifications remain unchanged. Information sheet Obligations Economic Operators CH (PDF, 1 MB, 01.01.2025) has been revised.
The device registration obligation will apply from 1 July 2026 (swissdamed)

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What are the tasks of Swissmedic in the area of medical devices?

What is a medical device? How do medical devices come onto the market? How do you recognise a medical device? Based on examples, our videos answer these and a number of other questions.

Medical devices: List of Field Safety Corrective Actions (FSCA) and recalls

Swissmedic monitors all safety measures and recalls for medical devices that are manufactured or marketed in Switzerland.


Swissmedic, Swiss Agency for Therapeutic Products

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Swissmedic – for therapeutic products you can trust

Swissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic Products.

For further information...
https://www.swissmedic.ch/content/swissmedic/en/home.html