Autogenous Vaccines: the Legal Basis and Regulation in the United Kingdom

摘要

The Veterinary Medicines Directorate is the competent authority in the U.K. for ensuring the quality, safety and efficacy of veterinary medicinal products placed on the market. The Immunologicals team is responsible for the assessment of immunologicalapplications for Marketing Authorisations and the Inspection of manufacturing sites that produce them. In addition to these activities, the team is also responsible for the assessment of applications for emergency product licences (autogenous vaccines)and the inspection of the facilities to manufacture them. These licences authorise the manufacture of inactivated vaccines, which are manufactured from pathogens obtained from an animal or animals from a holding and used for the treatment of the animalsin that holding.