After the EU Commission granted marketing authorisations in February 2025 for two BTV3 vaccines (Bluvac-3 from CZ Vaccines S.A.U., Spain; Syvazul BTV 3 from Laboratorios Syva S.A., Spain), a third authorised BTV3 vaccine is now available: Bultavo 3 from Boehringer Ingelheim Vetmedica GmbH.
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The authorisation was granted in a procedure pursuant to Article 49 of Regulation (EC) 2019/6, meaning that the vaccine has received a decentralised marketing authorisation. Unlike an authorisation granted by the EU Commission, this type of authorisation only applies in the Member States selected by the pharmaceutical company.
Bultavo 3 from Boehringer Ingelheim Vetmedica GmbH is intended for use in sheep and cattle. The vaccine is used in sheep for active immunisation to reduce viraemia (the presence of viruses in the blood) and clinical symptoms caused by bluetongue virus serotype 3 (BTV3). In cattle, the vaccine is intended to reduce viraemia caused by BTV3 as well as clinical symptoms.
In a decentralised procedure, the pharmaceutical company simultaneously applies for authorisation in all the Member States that they wished to be authorised in. One Member State acts as the Reference Member State (RMS) and undertakes the initial assessment of quality, efficacy, and safety. This assessment is recognised by the other Concerned Member States (CMS).
Applications for marketing authorisation in exceptional circumstances in accordance with Article 25 of Regulation (EC) 2019/6 are related to public or animal health. The benefit of immediate availability of the veterinary medicinal products on the market outweighs the potential risk posed by the fact that certain quality, safety, or efficacy documents cannot be provided. The quality, safety and efficacy of the vaccine were tested and evaluated with that context in mind. A marketing authorisation in exceptional circumstances is initially valid for a period of one year.
Updated: 04.06.2025
