Veterinary autogenous vaccines.
Autogenous vaccines remain a regulatory issue. They are demanded by practising veterinarians and by animal owners and they are quite widely used, mainly in Central European Countries, the Czech Republic, Hungary and Slovak Republic having probably the longest tradition with these products in Central Europe. The scope given in Article 3, Para. 2 (and/or Article 4 for some countries) of Directive 2001/82/EC applies to these products in the Acceding Countries. As these products are exempt from the harmonised regulation at the EU level, they are regulated by individual countries, the regulation varying from practically no regulatory measures in certain countries to a quite complex and demanding regulation in the other countries. Both risks and benefits are related to these products and they shall be taken into account when regulatory measures are considered. The major risks related to veterinary autogenous vaccines relate to possibility of transmission of TSE agents or other viral, bacterial and/or fungal contaminants. As appropriate and well balanced regulation of these products is deemed necessary, considering the risks related to these products, and based on the fact that national regulatory measures could be considered as a trade barrier under certain circumstances, harmonisation of the key issues or legal admission of the nationally based regulatory measures, including movement of these products from the other Member States, shall be laid down in the EU legislation. The veterinary autogenous vaccines complying with basic quality and safety requirements are thus a very useful tool in the animal health and welfare management but their use should be restricted to situations where there is no authorised veterinary medicinal product available and veterinary autogenous vaccines must not be allowed to replace good farming or veterinary practices.