European Medicines Agency to grant fee waivers to applications for bluetongue vaccines

1 April 2008

The European Medicines Agency has decided to grant fee reductions to all applications for inactivated vaccines against bluetongue, on the basis of the current epidemiological situation in relation to bluetongue, the lack of authorised vaccines in the market and the potential impact to animal health.

The fee reductions will be implemented as follows:

• 0% for the first application and 50% for the second and subsequent applications for identical vaccines that vary only in the strains of bluetongue virus included;
• 100% of the annual fee for any bluetongue vaccine that has not been marketed within the European Union (EU) or European Economic Area (EEA) during the year and 0% for any bluetongue vaccine that has been marketed within the EU or EEA during the year.

European Medicines Agency to grant fee waivers to applications for bluetongue vaccines

Reference Number: EMEA/111979/2008