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. In particular, the “rolling submission” and “rolling questions” procedures, which represent a special form of a first authorisation procedure or a variation procedure, are explained. These procedures are intended to enable applications to be submitted for immunological veterinary medicinal products used to mitigate and prevent the spread of epizootic diseases, for which the documentation is not yet complete.
The additional authorisation for use required for epizootic diseases is based on Art. 48 of the Epizootic Diseases Ordinance (EzDO).
The new guidance document is valid with effect from 15 January 2024.