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Information

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

01.03.2021

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

The adjustments are of a purely formal nature

17.02.2021

Swissmedic permanently involved in Project Orbis

The participation terms and processes have been set out in a new guidance document Project Orbis HMV4

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

01.12.2020

Supplying the population with essential human medicinal products

Swissmedic to provide scientific and regulatory advice free of charge

01.11.2020

Adaptation of guidance documents Fast-track authorisation procedure HMV4 and Temporary authorisation of human medicinal products HMV4

ZL104_00_002e_WL / ZL109_00_001e_WL

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Regulatory Assessment (XLS, 264 kB, 01.07.2021)

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

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