Context sidebar

Information

27.09.2021

Changes to the guidance document Formal requirements HMV4 and the form Import of a medicinal product according to Art. 14 (2) TPA (parallel import) HMV4

ZL_00_020e_WL / ZL106_00_002e_FO

17.09.2021

Changes to guidance document Authorisation of human medicinal product with new active substance HMV4

ZL101_00_005e_WL

01.09.2021

Changes to the guidance document Project Orbis HMV4

ZL000_00_048e_WL

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

01.09.2021

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

ZL000_00_022e_WL

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

12.04.2021

Authorisation of human medicinal products with new active substances and of additional indications 2020

New authorisations – Overview 2020

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

02.03.2021

Modification of the Full declaration form

ZL000_00_032e_FO

02.03.2021

Modification of the guidance document "Drug Safety Signals Human Medicinal product"

MU101_20_001e_WL

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLS, 265 kB, 01.09.2021)

Allocation of ATC code and IT groups KPA (XLS, 2 MB, 01.05.2021)

Top of page