19 January 2024 – In the exceptional situation of an impending or existing outbreak of an epizootic disease, Swissmedic can offer applicants a range of options in order to expedite authorisation or variation applications for immunological veterinary medicinal products that serve to mitigate and prevent the epizootic disease. The guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak explains the various advisory services and regulatory procedures for such authorisation and variation applications. The new guidance document is valid with effect from 15 January 2024.

For more information, see here.