Institute of Tropical Medicine Antwerp
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Regulatory issues surrounding the temporary authorisation of animal vaccination in emergency situations: the example of bluetongue in Europe

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Show simple item record Saegerman, C. en_US Hubaux, M. en_US Urbain, B. en_US Lengel , L. en_US Berkvens, D. en_US 2007-12-06T14:36:44Z 2007-12-06T14:36:44Z 2007 en_US
dc.identifier.issn 0253-1933 en_US
dc.identifier.other ITG-ALA en_US
dc.identifier.other ANIMAL en_US
dc.identifier.other U-ANIMAL en_US
dc.identifier.other JIF en_US
dc.identifier.other ABSTRACT en_US
dc.description.abstract A marketing authorisation for a veterinary vaccine is granted after the quality, safety and efficacy of the product have been assessed in accordance with legal standards. The assessment includes complete characterisation and identification of seed material and ingredients, laboratory and host animal safety and efficacy studies, stability studies, and post-licensing monitoring of field performance. This assessment may not be possible during the emergence of a new animal disease, but several mechanisms exist to allow for the availability of products in an emergency animal health situation, e.g. autogenous biologics, conditional licences, experimental and emergency use authorisations, the importation of products in use elsewhere in the world and pre-approved vaccine banks. Using the emergence of bluetongue in northern Europe as an example, the regulatory issues regarding the temporary authorisation of animal vaccination are described. Several conditions must be fulfilled before a temporary authorisation can be granted, e.g. inactivated vaccines should be used in order to exclude reversion to virulence and reassortment between vaccine viruses and/or field strains of the bluetongue virus; decision-making must be supported by scientific evidence and risk analysis; there must be a complete census of the susceptible animals that were vaccinated; vaccination protocols must be adhered to and there must be a scheme allowing for registration, delivery and follow-up of vaccination, and monitoring, analysis and, possibly, adjustment of field use of the vaccination. This temporary authorisation must be replaced by a full authorisation as quickly as possible. en_US
dc.language English en_US
dc.subject Animal diseases en_US
dc.subject Viral diseases en_US
dc.subject Bluetongue en_US
dc.subject Outbreak control en_US
dc.subject Vaccination en_US
dc.subject Legal aspects en_US
dc.subject Temporary authorization en_US
dc.subject Scan en_US
dc.subject Europe, West en_US
dc.title Regulatory issues surrounding the temporary authorisation of animal vaccination in emergency situations: the example of bluetongue in Europe en_US
dc.type Article en_US
dc.citation.issue 2 en_US
dc.citation.jtitle Revue Scientifique et Technique. Office International des Epizooties fr
dc.citation.volume 26 en_US
dc.citation.pages 395-413 en_US
dc.citation.jabbreviation Rev Sci Tech Off Int Epizoot fr

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