Conflicts is going to be solved yourself for the alarmed MS
good. elizabeth. then followed a payment Choice, the new MAH has to supply the translations of accompanied Annexes in all Eu languages (plus Icelandic and you can Norwegian in the event that applicable due to the fact detailed less than) with respect to the pursuing the timelines:
(Also Icelandic and you can Norwegian) can be provided electronically (in one single Eudralink bundle if the relevant) on Member claims contact issues to possess translations remark also to the newest EMA’s process secretary plus the PSUSA Mailbox.
If there is disagreement between a member State together with MAH, new EMA cannot interfere about interpretation procedure at this stage. Continue reading “In the event of CHMP advice otherwise CMDh position from the vast majority i”