How does a drug get licenced for horses?

[vanrim]

Someone asked me this recently and I didn’t know. So for example what had to happen for a company to take omeprazole and get it licenced for use in horses as a paste called GastroGard. I’ve tried googling but couldn’t find anything. Does anyone know?

 

[conniegirl]

It is pretty much the same as for humans except you go through the vet medicines directive rather than the MHRA.

So you need to submit a rather lengthy file to the VMD which proves the safety and efficacy in the target species, the quality plans for manufacturing.