A section on authorisation in exceptional circumstances in accordance with Art. 25 of EU Regulation 2019/6 has been added to the guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak.
The guidance document has also been modified to take account of the options for meetings for applicants.
The modified guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak will be valid from 1 June 2025.