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06.09.2024

Public Summary SwissPAR – Vabysmo®

Estensione dell’indicazione (01)

05.09.2024

Swissmedic Journal

Latest edition
Swissmedic Journal August 2024

03.09.2024

Swissmedic Regulatory & Beyond 2024

All information about the event is now available online

03.09.2024

Haemovigilance Annual report 2023

Evaluation of haemovigilance reports in 2023

02.09.2024

Clinical Study Assessor/in (80-100%)

Job advertisement | Abteilung Klinische Versuche (KLV)

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

Electronic data sets from pivotal bioequivalence studies

From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation

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

Guidance document Packaging texts for veterinary medicinal products

The guidance document Packaging texts for veterinary medicinal products has been revised

01.09.2024

SEND data sets for new authorisation applications for human medicinal products with new active substances

From 1 September 2024, Swissmedic is accepting SEND data sets for applications for new authorisation for human medicinal products with new active substances

01.09.2024

Combined studies

New forms and a new information sheet for submissions to Swissmedic

01.09.2024

Submission of accompanying documentation for applications for authorisation and variation for human medicinal products

Additional accompanying documentation for applications for authorisation and variation for medicinal products can now be submitted directly via the eGov portal with immediate effect
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