In the event of CHMP viewpoint otherwise CMDh standing from the bulk we
Disagreements is going to be solved truly to your alarmed MS
an effective. age. observed a percentage Decision, the MAH must supply the translations of one’s then followed Annexes in every Eu languages (together with Icelandic and you will Norwegian if relevant because in depth below) with regards to the following timelines:
(In addition to Icelandic and Norwegian) should be considering digitally (in one single Eudralink plan if the applicable) to the Associate claims contact circumstances to own translations comment in order to brand new EMA’s procedure assistant together with PSUSA Mailbox.
In the eventuality of conflict anywhere between a member County while the MAH, the newest EMA cannot interfere regarding interpretation techniques at that phase. Read more