Disputes might be fixed in person to the worried MS
an excellent. elizabeth. adopted a payment Decision, brand new MAH must provide the translations of your used Annexes throughout European union dialects (in addition to Icelandic and you may Norwegian if relevant as the intricate lower than) with respect to the following the timelines:
(Along with Icelandic and Norwegian) should be provided electronically (in a single Eudralink bundle in the event the relevant) toward Representative says contact points getting translations review and also to this new EMA’s process assistant and PSUSA Mailbox.
In case of conflict ranging from an associate State and also the MAH, the fresh new EMA cannot interfere regarding the interpretation process at that phase.
To assists and speeds brand new evaluate of implementation out of the’ comments, this new MAH is to suggest when you look at the Distribution off date +twenty five /235 latest unit advice annexes (people and you may veterinarian) – QRD Function dos and you can number for every vocabulary if most of the comments was indeed observed or not.Continue reading