General communications


Aufsichtsabgabe 2022 – Selbstdeklaration

Eingabefrist: 20. Januar 2023


Expansion of scope of temporary authorisations

Temporary additional indications will also be possible from 1 January 2023


Transfer of immunological veterinary medicinal products to Swissmedic

Publication of the revised specification documents and forms


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


Reports of suspected adverse reactions to COVID-19 vaccines

16,212 reports of suspected adverse vaccination reactions evaluated


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


Update – Warning about supposedly herbal products

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


Swissmedic approves bivalent COVID-19 booster vaccine from Pfizer

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


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

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


Potential nitrosamine contamination – harmonised implementation (update)

Regulatory and scientific developments regarding nitrosamines/Update September 2022


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

Swissmedic authorises indication extension and booster


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®


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


Swissmedic approves first bivalent COVID-19 booster vaccine in Switzerland

Moderna's Spikevax Bivalent Original/Omicron (mRNA-1273.214) authorised from age 18


Reports of suspected adverse reactions to COVID-19 vaccines

15,781 reports of suspected adverse vaccination reactions evaluated


Benchmarking study 2021

International comparison of Swiss approval times


Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Filing of Submission Plans to evaluate the efficacy of existing COVID-19 medicinal products against new SARS-Cov-2 variants


Operation PANGEA XV: International campaign against falsified and illegally imported medicinal products

Authorities checked shipments of medicinal products worldwide from criminal online sales


Reporting side effects electronically: new online reporting form for those affected or their relatives

Private individuals can now report suspected adverse drug reactions to Swissmedic via a web form


Reports of suspected adverse reactions to COVID-19 vaccines

15,578 reports of suspected adverse vaccination reactions evaluated


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

Clarifications on boxed warnings and other topics


Swissmedic position paper on the use of real-world evidence

Swissmedic considers real world data (RWD) as all data other than those collected through a clinical trial conducted as per ICH GCP

Last modification 22.11.2022

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