Vaccines for minor species and minor indications: current situation and concepts in Germany--feasible approaches for the future--authorities' view.

Abstract

About 350 immunological products for veterinary use are authorised for different species and indications in Germany. Vaccines licensed for minor species and minor indications are very rare. Existing products are being withdrawn from the market if the limited market size does not justify any investment for production and marketing, as well as to update the dossiers in accordance with the current regulatory requirements if normally only a limited data set regarding safety and efficacy of the products is available. Subsequently an increase of off-label use of authorised products and of autologous or of non-licensed immunological products are observed. The issue of availability of veterinary immunological medicines in minor species and minor indications has been recognised as a problem in the past few years. A brief review of the current legal situation in Germany and current examples are presented. It is therefore necessary to establish the standards of quality, safety and efficacy for veterinary immunological products intended for minor species and minor indications. There is a need to define a harmonised procedure to authorise products for minor species and minor indications on the basis of agreed minimum requirements. Feasible approaches for revision of requirements for the registration of vaccines for minor species and minor indications are proposed.