Vaccines for minor use and minor species: technical difficulties to solve and consequences in legal definitions.

Abstract

To identify the difficulties of the problem and to try to find some solutions with their consequences in legal provisions, different aspects have to be considered: the possible definitions of minor species and minor indications and the limits of such definitions, the present applicable directives and possible modifications induced by extrapolation of technical results, by reduction of requirements. According to the complexity of the problem, a pragmatic approach with a certain flexibility, founded on a case-by-case assessment, seems to be necessary. The basis of the CVMP position paper regarding the availability of products for minor uses and minor species mainly focused on medicinal products and MRLs is interesting to consider in the case of vaccines, in the light of technical requirements of Title II of EU Directive 2001/82/EC. Even if definitions of minor species and minor uses are needed to give a legal basis for the problem, they have limits and some examples will be given. Reduction of requirements and extrapolation seem possible in a relatively easy way when data are available for major use and major species. A reduction of requirements is much more difficult to set up when such data are not available. Requirements for quality, safety and efficiency will be assessed including the indications of notifiable diseases. When all these aspects have been considered, it is essential to avoid a disharmonised approach from the National Regulatory Authorities. So, the possibilities of a specific legal framework on << Minor Uses and Minor Species >> and a centralised procedure for marketing authorisations have to be discussed.