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Information

01.05.2022

Changes to guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Clarifications on the prioritisation and fast-tracking of pandemic medicinal products and on the patient information requirements

23.03.2022

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

25.02.2022

Authorisations of human medicinal products with a new active substance and additional indications 2021

Overview of new authorisations 2021

01.02.2022

Use of titanium dioxide in medicinal products

The pharmaceutical excipient titanium dioxide remains permissible in Switzerland until further notice

01.01.2022

Changes to the guidance document Project Orbis HMV4

Change in procedure for Project Orbis: Swissmedic information requests now to be sent exclusively to the applicant in Switzerland

01.01.2022

Changes to the guidance document Temporary authorisation of human medicinal products HMV4

Simplification of the procedure for “ex officio" temporary authorisation

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.

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.

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLS, 265 kB, 19.05.2022)

Allocation of ATC code and IT groups KPA (XLS, 2 MB, 01.03.2022)

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