One of the draft amendments to the MOH Order 426 is removed
European Business Association (EBA) is pleased to inform that the recent communications with the state authorities resulted in the removal of one of the draft amendments proposed to the MOH Order 426. Thus, the Draft MOH Order was web-published for a second time today.
Initially, the above-mentioned draft amendment proposed not to submit RMP (risk management plans) for generic drugs in case the original medical drug is registered in Ukraine. The above-mentioned amendment wasn’t in line with the EU rules and practices. It wasn’t discussed with professional community and appeared surprisingly.
Now that the Draft MOH Order is re-published for public discussion, the above-mentioned proposal is removed.
We are thankful to MOH and all involved state authorities, hope for the due attention to the necessity of pre-communication in professional circles before any amendments are web-proposed for public discussion, and looking forward to further effective cooperation in the long run.