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Information

01.11.2021

New guidance document: Involvement of patient organisation in assessment of patient information HMV4

The new guidance document is valid with effect from 1 November 2021.

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

02.03.2021

Modification of the form New authorisation of human medicinal products

ZL100_00_001e_FO

02.03.2021

Modification of the form Variations and extensions

ZL300_00_003e_FO

01.03.2021

Standardisation of headers and footers in Authorisation division guidance documents and forms

The adjustments are of a purely formal nature

15.12.2020

Optimising authorisation-related meetings with applicants

ZL105_00_003e_WL / ZL105_00_004e_FO

15.12.2020

Accelerated Application Hearing replaces existing application procedure for an FTP / temporary authorisation of human medicinal products

ZL104_00_002e_WL / ZL109_00_001e_WL / ZL104_00_001e_FO

05.12.2020

Changes to the guidance document Authorisation of herbal medicinal products HMV4

ZL101_00_008e_WL

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