In case there are CHMP thoughts or CMDh updates because of the majority we
Disagreements shall be set myself into the worried MS
an excellent. e. adopted a percentage Decision, brand new MAH has to deliver the translations of your implemented Annexes throughout Eu dialects (plus Icelandic and Norwegian if relevant once the intricate lower than) according to after the timelines:
(Also Icelandic and Norwegian) should be provided electronically (in one single Eudralink plan when the relevant) with the Member says get in touch with items having translations feedback and also to the fresh new EMA’s procedure assistant additionally the PSUSA Mailbox.
In case there is dispute anywhere between an associate Condition and the MAH, brand new EMA does not interfere regarding translation techniques at that phase.
To assists and accelerate the new consider of the implementation away from the’ comments, the fresh new MAH is to imply in the Entry off day +twenty-five /235 final unit information annexes (peoples and you can veterinarian) – QRD Means 2 and number each language if most of the comments had been implemented or otherwise not. From the second instance, a reason will likely be delivered to the appropriate vocabulary(s) saying why particular comments aren’t mirrored from the latest texts.
b. In case there is CMDh standing from the consensus, Associate Claims can get perform a voluntary linguistic comment from the translation techniques, and following timelines implement:
