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General communications

22.03.2023

Swissmedic partially lifts suspensions for Amino AG: medicinal product authorisations are valid again, manufacturing activities still suspended

Interim decision concerning suspension of establishment licences and medicinal product authorisations of Amino AG

01.03.2023

New Mobile technologies guidance document for human and veterinary medicinal products

Regulations on the use of QR codes on packaging and in medicinal product information

24.02.2023

Reports of suspected adverse reactions to COVID-19 vaccines

16,855 reports of suspected adverse vaccination reactions evaluated

13.02.2023

Public consultation on ICH Guideline M13 “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” launched in Switzerland

Swissmedic launches the public consultation on Guideline M13 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 26 May 2023 for comments

10.02.2023

Illegal imports 2022: many confiscated shipments contained erectile stimulants

Number of illegally imported therapeutic products has decreased

26.01.2023

Swissmedic and the UK Veterinary Medicines Directorate agree collaboration on veterinary medicinal products

Raimund Bruhin (Executive Director, Swissmedic) and Gavin Hall (Deputy CEO, Veterinary Medicines Directorate) have signed a Memorandum of Understanding on collaboration in the area of veterinary medicinal products.

13.01.2023

Suspension of the establishment licences of Amino AG and Dr. Heinz Welti AG

Information for professionals, updating the communication dated 14 December 2022 on key aspects connected with the suspension of the establishment licences and authorisations of the companies Amino AG and Dr. Heinz Welti AG

10.01.2023

Illegal imports of medicines: Swissmedic warns against the risk of dependence associated with the long-term use of nasal sprays and laxatives

Increase in illegal imports of nasal sprays and laxatives

01.01.2023

Changes to SwissPAR HMV4 guidance document

Section 5, Clinical Assessment, of the Public Assessment Report is not part of the SwissPAR

14.12.2022

Amino AG/Dr. Heinz Welti AG: Suspension of establishment licences and authorisations

Medicinal products that have already been delivered can still be distributed

13.12.2022

Reporting suspected adverse reactions following vaccination against mpox (monkeypox)

Suspected adverse reactions can be reported electronically

09.12.2022

Federal Council approves Swissmedic's strategic goals for 2023–2026

Swissmedic guarantees efficient, independent therapeutic products oversight

02.12.2022

Aufsichtsabgabe 2022 – Selbstdeklaration

Eingabefrist: 20. Januar 2023

01.12.2022

Expansion of scope of temporary authorisations

Temporary additional indications will also be possible from 1 January 2023

01.12.2022

Transfer of immunological veterinary medicinal products to Swissmedic

Publication of the revised specification documents and forms

30.11.2022

Meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Excellent Progress by ICH Expert Working Groups in Incheon, Republic of Korea

28.11.2022

Public consultation on ICH Guideline M11 “Clinical electronic Structured Harmonised Protocol (CeSHarP)” launched in Switzerland

28.11.2022

Public consultation on ICH Guideline Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin” launched in Switzerland

25.11.2022

Reports of suspected adverse reactions to COVID-19 vaccines

16,212 reports of suspected adverse vaccination reactions evaluated

23.11.2022

Swissmedic responsible for animal vaccines from 1.1.2023

21.11.2022

Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition

Access Consortium commits to demonstrate greater inspection reliance and accept GMP inspection outcomes held amongst their members

10.11.2022

More than 700 participants at the information event on the new in vitro diagnostic medical devices regulation

Successful Swissmedic online event on 3 November 2022

07.11.2022

Update – Warning about supposedly herbal products

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

02.11.2022

Reports of formation of bubbles in a batch of the COVID-19 vaccine Comirnaty Bivalent Original/Omicron BA.1

risks currently being investigated

10.10.2022

Swissmedic approves bivalent COVID-19 booster vaccine from Pfizer

Comirnaty Bivalent Original / Omicron BA.1 (tozinameran / riltozinameran) from Pfizer authorised from age 18

22.09.2022

Pfizer AG applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine

Application submitted for Comirnaty Original/Omicron BA.4-5

14.09.2022

Potential nitrosamine contamination – harmonised implementation (update)

Regulatory and scientific developments regarding nitrosamines/Update September 2022

02.09.2022

COVID-19 vaccine Nuvaxovid: temporary authorisation from 12 years of age and as booster

Swissmedic authorises indication extension and booster

02.09.2022

Pfizer applies for indication extension of COVID-19 vaccine to include children aged 6 months to less than 5 years

Swissmedic reviews Pfizer Schweiz AG application for Comirnaty®

01.09.2022

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

Clarification of safety-relevant updates to medicinal product information for authorisations according to Art. 14 para. 1 let. abis TPA

Last modification 22.11.2022

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