06.12.2019

Trace amounts of a nitrosamine impurity found in individual diabetes medicines

Isolated traces of the nitrosamine NDMA have been detected in individual diabetes preparations with the active substance metformin – investigations are ongoing worldwide.

06.12.2019

Swissmedic Journal

Latest edition
Swissmedic Journal November 2019

05.12.2019

Out-of-Stock – Braftovi, Hartkapseln und Mektovi, Filmtabletten

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

03.12.2019

13 new psychoactive substances added to Narcotics List

FDHA has prompted to add substances to the Narcotics List to combat drug trafficking

In focus

Medical devices
New EU regulations (MDR, IVDR)

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

Swiss Public Assessment Reports (SwissPAR)

Reports on the results of the assessment of authorisation applications.

Cablivi (PDF, 445 kB, 08.11.2019)
Onpattro (PDF, 1 MB, 13.11.2019)

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Incident reporting

Medicines

Reporting undesirable effects


Medical devices

Reporting incidents & FSCAs

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04.12.2018

Therapeutic Products Legislation update

The modifications following the ordinary revision of the TPA and its right of enforcement will enter into force on 1 January 2019

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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