Swissmedic responsible for animal vaccines from January 1, 2023

Bern, 23.11.2022 – From January 1, 2023, Swissmedic (the Swiss Agency for Therapeutic Products) will be responsible for both licensing and monitoring the safety of immunological veterinary medicinal products. These duties are being transferred from the Institute of Virology and Immunology (IVI). The Federal Council adopted the necessary ordinance amendments at its meeting on November 23, 2022. The transfer will provide a sustainable solution for these important veterinary products and increase efficiency.

The Swiss Therapeutic Products Act (Federal Act on Medicinal Products and Medical Devices; TPA) regulates the placing on the market of such products and devices. It is the legal basis on which Swissmedic (the Swiss Agency for Therapeutic Products) monitors the entire lifecycle of medicinal products for humans and animals.

Immunological veterinary products, including vaccines for pets and livestock, were previously an exception. Historically, responsibility for licensing and monitoring these products lay with the Institute of Virology and Immunology (IVI), as quality assurance entailed laboratory tests and animal experiments.

However, the development of new testing methods has changed the vaccine control requirements. In addition, new active substances and new areas of application in veterinary medicine are resulting in ever more complex dossiers that require a certain critical mass for processing and would have meant an extensive and expensive overhaul of IT systems. Swissmedic, conversely, has the necessary knowledge and appropriate infrastructure.

Responsibility for immunological veterinary medicinal products will therefore transfer to Swissmedic from January 1, 2023. This will make it possible to bundle responsibilities, increase efficiency, exploit technical synergies and improve customer service.

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