General communications


Swissmedic approves Pfizer coronavirus vaccine Comirnaty XBB.1.5

Comirnaty XBB.1.5 approved for persons aged 12 and over


Changes to the guidance document Temporary authorisation of human medicinal products

Clarification regarding authorised medicinal products, harmonised deadlines for applications before expiry of temporary authorisation and changes to terminology


Implementation of the full declaration for homeopathic and anthroposophic medicinal products without indication

The requirements for the declaration of active substances and pharmaceutical excipients of human medicinal products (full declaration) also apply to homeopathic and anthroposophic medicinal products without indication.


Complementary and herbal medicines containing ethanol in paediatric populations

The benefits of the use of the medicinal product containing ethanol must outweigh the potential risks.


Authorisation application submitted for coronavirus vaccine Nuvaxovid XBB.1.5

Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5


Potential risk to children whose fathers have taken the active substance valproate

Precautionary change to the medicinal product information for valproate products


Benchmarking study 2022

International comparison of Swiss authorisation times


Swissmedic gains accreditation for GMP/GDP inspections in the field of ATMPs

In particular, this accreditation confirms the existence of a functioning quality management system and the expertise of the inspectors.


Swissmedic participation in the European Medicines Agency (EMA) OPEN initiative

Opening procedures at EMA to non-EU authorities (OPEN) initiative


MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect

Mutual recognition in principle of inspections by Swissmedic and the FDA


New blood donation criteria for men who have sex with men

Swissmedic amends donation criteria at request of Swiss Transfusion SRC


Switzerland becomes Official Observer in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

At Swissmedic and scienceindustries's request, the VICH has granted the status of Official VICH Observer to Switzerland


Pfizer AG submits authorisation application for coronavirus vaccine Comirnaty XBB.1.5

Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5


Trips abroad with medications – what you need to know

Anyone who relies on medication should find out about the regulations in their destination country and any countries they travel through before taking a trip abroad


Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5

Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5


Claus Bolte becomes Chief Medical Officer

Claus Bolte has taken on the newly created role of Chief Medical Officer at Swissmedic effective 1 July 2023


Public Consultation on ICH Reflection Paper launched in Switzerland

International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines


Swissmedic issues warning about falsified Ozempic pens

Hospitalisations following use of falsified Ozempic pens – Swissmedic advises against purchasing medicinal products online and from unreliable sources abroad


Nitrosamine impurities in medicinal products: Swissmedic sets up specialist group

“Nitrosamine Specialist Group”: centre of expertise and coordination office for nitrosamine issues


Revision 1.7.2023 – Updating of KPTPO annexes

KPTPO: Updating of Annexes 6, 9 and 10


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

New Areas of Harmonisation adopted alongside Significant Advancement of Ongoing Activities in Vancouver, Canada


Medicinal products with a medical device component (combination products)

Implementation of the transitional provisions for medical devices


Swissmedic publishes its Annual Report for 2022

On 9 June 2023 the Federal Council approved Swissmedic's Annual Report for 2022.


Public consultation on ICH Guideline E6(R3) “Good Clinical Practice (GCP)” launched in Switzerland

Stakeholders in Switzerland have until September 26th, 2023 to comment on the draft of Guideline E6(R3) “Good Clinical Practice (GCP)”


Establishment licence for Dr. Heinz Welti AG: Suspension of establishment licence at Gebenstorf site lifted

Manufacturing and distribution activities at the Bubendorf site still suspended


Establishment licence of Amino AG: Manufacture of non-sterile medicinal products permitted again at the Gebenstorf site

Manufacturing and distribution activities at the Belp site still suspended


Changes to the forms for new authorisations of and variations to human and veterinary medicinal products

Information on study design and data sources of RWE in application forms


Modification of the DMF form

Details of a contact for enquiries on the DMF form

Last modification 22.11.2022

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