Division II.1 Availability of alternative medicines

The need for the substance in order to avoid unnecessary suffering for target animals or to ensure the safety of those treating them may be relevant factors to consider in those cases where practical treatment alternatives are lacking. These considerations may justify acceptance of a reduced data package in line with the recommendations provided in F1guidance issued by the appropriate authority. These factors may also be considered in relation to the need to set MRLs at levels that will allow development of a product with a practicable withdrawal period, F2....