Disputes would be solved really into the worried MS

an excellent. elizabeth. accompanied a percentage Decision, this new MAH has to provide the translations of one’s implemented Annexes in all Eu languages (and additionally Icelandic and you can Norwegian in the event the appropriate given that in depth less than) according to the after the timelines:

(Also Icelandic and you will Norwegian) should be given electronically (in one Eudralink bundle if the applicable) on User states contact products for translations comment and to this new EMA’s processes secretary and also the PSUSA Mailbox.

In case there is argument anywhere between an associate County together with MAH, the EMA does not interfere from the interpretation techniques at that stage.

To help you helps and you can speed the fresh look at of your implementation from the’ comments, the MAH is always to imply when you look at the Submitting off time +twenty-five /235 latest device information annexes (people and you will veterinary) – QRD Setting dos and you may list for every words if the every statements was indeed accompanied or not. About latter situation, an excuse should be delivered to the right vocabulary(s) claiming why particular comments aren’t shown on last texts. Read More