Transfer of immunological veterinary medicinal products to Swissmedic
Publication of the revised specification documents and forms
01.12.2022
On 1 January 2023, responsibility for the authorisation, variation, batch release, market surveillance and licences for importing individual batches of immunological veterinary medicinal products will be transferred from the Institute of Virology and Immunology (IVI) to Swissmedic. During its session on 23 November 2022, the Federal Council approved the necessary revisions to ordinances. This change enables us to pool responsibilities, increase efficiency, utilise specialist synergies and improve customer service for these important veterinary medicinal products.
Swissmedic has revised the most important documents and forms required for the authorisation and control of immunological veterinary medicinal products. You can find the revised documents, which are valid from implementation, under “Documents and forms”. These texts are being published in advance for information purposes only. The documents valid until the end of 2022 are also available.
Requirements documents:
Further information for immunological veterinary medicinal products
Applications for authorisation and variation
Applications for the authorisation or variation of immunological veterinary medicinal products will be accepted from 1 January 2023 at the earliest.
Pharmacovigilance
After the transfer, adverse reactions to immunological veterinary medicinal products should continue to be reported via www.vaccinovigilance.ch
OMCL
Information on official batch release can be found at the following link:
Establishment licences / certificates
From 1 January 2023, applications for a licence to import individual batches must be submitted to Swissmedic using the official form in accordance with Art. 44 et seq. MPLO (SR 812.212.1). You can find the guidance document and form here:
Market monitoring of medicinal products
From 1 January 2023, please send reports of quality defects or out-of-stock applications using the linked form to market.surveillance@swissmedic.ch
Further information on the implementation of the transfer of immunological veterinary medicinal products
