Veterinary vaccines must be authorised by the relevant competent authorities in the EU. An application for a Marketing Authorisation (MA) must be submitted and this should include a dossier that demonstrates the quality of the vaccine and the safety and efficacy in the target species. It should be noted that safety must also be demonstrated for the user, the environment and the consumer.
CITATION STYLE
Banks, R. (2014). Veterinary vaccines: EU regulatory requirements. In Molecular Vaccines: From Prophylaxis to Therapy - Volume 2 (pp. 859–865). Springer International Publishing. https://doi.org/10.1007/978-3-319-00978-0_30
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