If there is CHMP thoughts or CMDh position of the vast majority we

Conflicts are going to be solved privately into alarmed MS

a. age. followed a payment Choice, the new MAH must provide the translations of then followed Annexes throughout European union languages (along with Icelandic and you can Norwegian – if the applicable because the detailed below) with regards to the adopting the timelines:

(As well as Icelandic and you will Norwegian) can be considering electronically (in one Eudralink bundle when the appropriate) towards the Representative claims get in touch with affairs to have translations review also to the fresh EMA’s process secretary in addition to PSUSA Mailbox.

If there is conflict ranging from a part State in addition to MAH, the fresh new EMA doesn’t meddle from the interpretation process at that stage.

In order to assists and you may speeds new glance at of the implementation out-of the’ comments, the latest MAH is always to suggest when you look at the “ Entry off time +twenty-five /235 final device advice annexes (human and you may veterinary) – QRD Means 2 and you can list” for each words in the event that most of the statements had been used or otherwise not.

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