Archive

Please note that documents represented the latest scientific and technical findings and complied with the applicable legal requirements at the moment of their publication. After they have been published under “Latest news” and “Communications” on specific topics relating to complementary and herbal medicine, they will be moved to the Archive in due course so that they remain available as a compilation of information. Archived documents are not updated.

The current legislation and the latest scientific and technical findings are authoritative.

06.12.2024

Aufsichtsabgabe 2024 – Selbstdeklaration

Eingabefrist: 24. Januar 2025

21.10.2024

Batch recall – Diverse spagyrische Arzneimittel und Sets der Aurora Pharma

Alle im Rückrufschreiben erwähnten Chargen bis auf Stufe Detailhandel

15.10.2024

Changes to the guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

Optimisation of the application procedure for the implementation of a fast-track authorisation procedure and the implementation of temporary authorisation

08.10.2024

Regulatory & Beyond 2024

Dienstag, 26. November 2024, Kursaal Bern

01.09.2024

New form No marketing / interruption of distribution for veterinary medicinal products

A new separate form has been created for notification of no marketing and interruption of distribution for veterinary medicinal products.

01.09.2024

Mobile technologies – Submission of films as additional information regarding the safety, efficacy and quality of medicinal products

From 1 September 2024, Swissmedic will be accepting the submission of films as part of the authorisation of QR codes

01.09.2024

Changes to the guidance document Time limits for authorisation applications

To standardise practice, written notification regarding the “Doc. OK” milestone will in future no longer be sent following a formal objection

24.07.2024

Benchmarking study 2023

International comparison of Swiss authorisation times

02.07.2024

Update to the forms New authorisation of human medicinal products and Variations and authorisation extensions HAM

Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities

Last modification 10.08.2022

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