Information

01.07.2021

Modification of various documents relating to authorisation

ZL109_00_001e_WL / ZL104_00_002e_WL

26.05.2021

Revised requirements for combination products

(medicinal products with a medical device component)

18.05.2021

Adaptation of COVID-19 vaccines to new SARS-CoV-2 variants

The adapted guidance document comes into effect on 15 May 2021.

16.04.2021

Potential nitrosamine contamination

Update – April 2021

02.03.2021

Modification of the Full declaration form

ZL000_00_032e_FO

17.02.2021

Swissmedic permanently involved in Project Orbis

The participation terms and processes have been set out in a new guidance document Project Orbis HMV4

15.12.2020

Optimising authorisation-related meetings with applicants

ZL105_00_003e_WL / ZL105_00_004e_FO

01.12.2020

Supplying the population with essential human medicinal products

Swissmedic to provide scientific and regulatory advice free of charge