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General communications

28.06.2022

From 1 September 2022, Swissmedic will no longer issue authorisations for the import of veterinary medicinal products by medical professionals (“special authorisations”)

Transitional phase from 1 July 2022 to 31 August 2022

24.06.2022

Moderna applies for an authorisation extension for a coronavirus vaccine against Omicron

Spikevax®: Swissmedic launches rolling review procedure for a vaccine candidate adapted to SARS-CoV-2 variants (mRNA-1273.214)

14.06.2022

International cooperation on therapeutic products

First application reviewed by all five Access Consortium Authorities

10.06.2022

Swissmedic Annual Report 2021: The second year of coronavirus as a particular challenge

Swissmedic publishes Annual Report 2021

31.05.2022

Swissmedic reviews Pfizer application for a booster for children aged 5 to 11 years

Pfizer Schweiz AG has submitted an application for a new dosage recommendation for Comirnaty® paediatric vaccine

30.05.2022

Latest information on the Field Safety Notice issued by Philips Respironics regarding specific ventilators, sleep apnoea and respiratory care devices

Information on the status of ongoing corrective actions

26.05.2022

New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022

Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)

18.05.2022

Spikevax COVID-19 vaccine for children up to 5 years: application for indication extension submitted

Swissmedic is reviewing application from Moderna Switzerland GmbH

12.05.2022

Regulatory training for French-speaking authorities in May 2022

Swissmedic training courses

06.05.2022

Reports of suspected adverse reactions to COVID-19 vaccines

15,228 reports of suspected adverse vaccination reactions evaluated

04.05.2022

Update – Warning about supposedly herbal products

Swissmedic is issuing an urgent warning regarding slimming products and other supposedly natural products

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

12.04.2022

Twelve rather than nine-month shelf life for Pfizer/BioNTech vaccine «Comirnaty»

The Agency for Therapeutic Products has reviewed the application and approved the extension

08.04.2022

Reports of suspected adverse reactions to COVID-19 vaccines

14,624 reports of suspected adverse vaccination reactions evaluated

05.04.2022

Public Consultation on Guidelines of the International Council for Harmonisation (ICH Guidelines)

Swissmedic procedure for public consultation on ICH Guidelines

01.04.2022

Aid for Ukraine: export of medicinal products to the conflict area – update

Swissmedic recommends cooperation with established aid organisations

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

11.03.2022

Reports of suspected adverse reactions to COVID-19 vaccines

13,388 reports of suspected adverse vaccination reactions evaluated

08.03.2022

War in Ukraine: export of medicinal products to the conflict area

Private individuals should support Ukraine via aid organisations

25.02.2022

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

Overview of new authorisations 2021

Last modification 19.04.2021

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