Bioequivalence and Bioavailability Forum

Dear Hermann,

Yes MOH = Ministry of Health. The guidlines which I have referred is from MCC South Africa Dec 2003 version. Of course the guidline on Biowaivers can slightly vary on limits but in my opinion over all the summarised points are important to consider when any BW is sought.

regaffairs though quoted ..but did not spell out on which point exactly the MOH rejected the BW application.. hence I have asked whether the points quoted are taken care enough ... Of course the final decision to grant BW or not is with the MOH.

But if the BW is rejected due any other reason other than I have summarized, if regaffairs can uncover the details so that our group members can be benefited.

With regards,

Ahmed