Information

01.09.2021

Update to the forms New authorisation of human medicinal products HMV4 and Variations and authorisation extensions HMV4

Consent to exchange of information for applications in collaboration with Access Consortium and Project Orbis

04.08.2021

Executive Summary - Benchmarking 2021

Comparison of Swiss approval times for human medicines with the EU and the USA

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