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Information

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

01.11.2020

Naming of combination partners

Changes to the guidance document Product information for human medicinal products HMV4

18.08.2020

Benchmarking 2020 – Comparison of Swiss approval times for human medicines with the EU and the USA and analysis of national authorisation procedures

Swissmedic compared with the EMA and the FDA and analysis of the national authorisation procedures

03.07.2020

A study confirms Swissmedic’s international Competitiveness

In an international comparison of the processing time for scientific assessments, Swissmedic is on a par with the fastest authorities

01.07.2020

New ruling concerning extensions granted for authorisation applications for human medicinal products

Swissmedic is changing its practice

01.07.2020

Optimisation of labelling phase for human medicinal products

Avoiding text review rounds

01.07.2020

List of medicinal products in dispensing category D dispensed by naturopaths with a federal diploma (NP FD)

Human medicinal products in dispensing category D that may be dispensed by naturopaths

04.06.2020

Allocation of CHM to Case Management

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