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


Use of titanium dioxide in medicinal products

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


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


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

Simplification of the procedure for “ex officio" temporary authorisation


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.


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


Executive Summary - Benchmarking 2021

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


Modification of various documents relating to authorisation

ZL109_00_001e_WL / ZL104_00_002e_WL


Revised requirements for combination products

(medicinal products with a medical device component)