Consideration of Alternative Licensing Procedures for Vaccines for Minor Species, Minor Indications and Autogenous/Autologous Products

摘要

It is often reported that the regulatory process is seen to be too vigorous, too demanding and often too lengthy, so that it provides little incentive to develop products for minor uses and minor species that are the topic of this conference. In addition to the regulatory processes themselves as enshrined in EU legislation, we have to take account of political pressure and society values, as well as the pressures from the animal health industry, to provide products for the veterinarians, who are charged with a duty of care for the minor species that are the subject of discussion. However, it is imperative that whatever solutions may be found to make the provision of products and vaccines in particular for minor species easier, there is always a requirement to safeguard consumer health and safety; having to take regard of a system that for many years has worked extremely well bringing safe products into the market-place.