Division 5.6 Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation

A summary of all data and information provided under points 5.1 through 5.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.

It must be explained whether exposure of animals or humans has any implications for vaccination or serological monitoring.