If there is CHMP view otherwise CMDh status because of the bulk we
Disagreements can be fixed individually towards the concerned MS
an effective. age. followed a payment Decision, this new MAH has to supply the translations of your adopted Annexes in all Eu dialects (plus Icelandic and you will Norwegian if the appropriate because in depth below) according to following the timelines:
(Plus Icelandic and you can Norwegian) will be provided digitally (in one single Eudralink plan if the relevant) towards the User says get in touch with issues for translations feedback in order to the fresh new EMA’s process secretary together with PSUSA Mailbox.
In case of argument anywhere between a part Condition and MAH, this new EMA cannot meddle on the translation process at this phase. Read more