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Autogenous vaccines in Europe - national approaches to authorisation

Abstract : Introduction Autogenous vaccines are “immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals from a holding and used for the treatment of that animal or the animals of that holding in the same locality”.1 They are a useful addition to licensed vaccines2 in animal disease control and in maintaining animal health. The use of vaccines, including autogenous vaccines, can be an additional prophylactic tool to avoid occurrence of diseases which require antibiotic treatment. The wide use of autogenous vaccines and cross-border movement of animals vaccinated with autogenous vaccines is now becoming a common practice within Europe. However, there are no harmonised requirements for the manufacture, control and use of autogenous vaccines across the EU. National laws and/or legislation are di.erent when they exist, and sometimes there is no speci.c legislation covering use and production of autogenous vaccines. In this article, an overview of the European situation is provided, detailing the answers received in response to the CMDv questionnaire. The aim of this questionnaire was to have an update on the situation of autogenous vaccines in Europe. A total of 22.member states provided answers to the survey even if they did not respond to all questions. The questionnaire was divided in three parts: general questions on the regulatory matters concerning autogenous vaccines; details on the types of autogenous vaccines; details on their manufacturing. First, if compared to a 2004 VMRFG3 questionnaire on the same matters, it has been observed that there have been no fundamental changes in use and requirements between 2004 and 2014, but member states have gained more experience with these types of vaccines and their use has increased (volume/batches).
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Submitted on : Friday, July 28, 2017 - 5:20:04 PM
Last modification on : Wednesday, November 3, 2021 - 6:56:50 AM


  • HAL Id : anses-01570260, version 1



Mariette Saléry. Autogenous vaccines in Europe - national approaches to authorisation. Regulatory rapporteur, Topra, 2017, 14 (6), pp.27-30. ⟨anses-01570260⟩



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