Information shall be provided showing whether the constituents of the veterinary medicinal product are used as medicinal products in human therapy; if this is so, a report should
be made on all the effects observed (including side-effects) in humans and on their cause, to the extent that they may be important for the assessment of the veterinary medic
inal product, where appropriate in the light of trial results of bibliographical documents; where constituents of the veterinary medicinal products are themselves not used or are no lon
...[+++]ger used as medicinal products in human therapy, the reasons should be stated.