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On absence of a reply in this 2 days, this new EMA have a tendency to think that zero oral cause is expected
- propose a text if for example the recommendation is actually a version but no accurate text was proposed from the PRAC Rapporteur / Direct User State,
- offer a justification in the event the MAH does not agree with new PRAC Rapporteur / Associate County testimonial to alter, suspend or revoke new MA; and/or
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The fresh MAH’s statements is going to be filed as per the PSUR dossier entry standards detail by detail on the question Just how should I complete the answer to an ask for secondary pointers throughout the an excellent PSUSA processes?.
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