Minor Species/Minor Indications -Introductory Remarks

摘要

The current European provisions concerning the licensing of vaccines do not provide exemptions for minor species/minor indications or rather minor use (MUMS) vaccines. Consequently, a lack of suitably authorised veterinary medicinal products in general and of vaccines in particular occurs. This is a problem both for animal welfare and for public health. In addition, the numerous mergers of manufacturers have led to a more global approach to market analysis. Therefore, the readiness to produce minor products for minor markets has decreased.