Please be informed that the marketing authorisation for Vaxzevria, COVID-19 vaccine, manufactured by AstraZeneca ceased to be valid in Montenegro at the request of the marketing authorisation holder. Marketing authorisation holder in the European Union also withdrew the marketing authorisation, so the mentioned vaccine is no longer authorised for marketing in the EU Member States either.

This is due to the fact that there are no commercial interests for marketing of this vaccine in Montenegro, and for the same reason this vaccine was withdrawn in the European Union as well. Data on the quality, safety and efficacy of this vaccine were not the reason for withdrawing the marketing authorisation, but in the meantime new vaccines adapted to new strains of the SARS-CoV-2 virus have been developed and authorised, and therefore the need for further use of the Vaxzevria vaccine ceased to exist.

Even though the marketing authorisation for Vaxzevria vaccine was valid in the previous period in Montenegro, the last application for its import was submitted and approved by CInMED in May 2021 and after that, no new import application was submitted, so the mentioned vaccine is not present on the market in Montenegro.