The criteria efficacy, quality and safety are decisive for the benefit
-risk-ratio of a drug. The efficacy of homeopathic drugs is proved emp
irically and by good clinical studies for a long time. The requirement
s concerning the quality of a homeopathic drug are identical with thos
e of conventional drugs. The safety of veterinary homeopathic drugs is
demonstrated by means of some worst case calculations for the remedy
Arsenicum album. Additionally, safety is guaranteed by the inclusion o
f the scientifically evaluated experiences and observations in homeopa
thy, by the requirement for a prescription in the case of potentially
harmful substances and by the application of relatively small doses in
food production animals. The homeopathic veterinary drugs marketed in
Germany are in full accordance with the present legal regulations. In
view of the extraordinary favourable benefit-risk-ratio of these prep
arations, the restrictions for the use of these drugs resulting from E
uropean laws are difficult to understand.