Posted by europerep on November 20, 2011, at 14:17:34
In reply to Re: 2nd MAOI after the first one failed? » europerep, posted by ed_uk2010 on November 19, 2011, at 12:39:18
>If they wanted to change the formulation so that it was the same as American Nardil, testing and MHRA approval would still be needed.
Ah, I think now I got it. I thought that regulatory bodies such as the MHRA or its counterparts in other countries (or the EMA) would basically say "here is box A with all the drugs that we have approved, and here is box B with all the fillers, excipiens etc. that we approved as well. Throw together any combination of those substances and you are free to sell it." I didn't know that preparations (and not just the active drugs they contain) had to be approved too. Good to know though, thanks for explaining it to me! :)
poster:europerep
thread:990065
URL: http://www.dr-bob.org/babble/20111120/msgs/1003226.html