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4 THE EUROPEAN CONTROLS OF MEDICINAL PRODUCTS 435 Application to first Member State First authorisation (210 days from the application) Objections to be raised by Day 50 of the procedure Request for mutual recognition by applicant Update and issue of Assessment Report within 90 days Mutual recognition procedure starts after validation (Day 0) Applicant responds within 10 days After dialogue and Breakout Session on Day 75: Issue resolved by Day 89 After dialogue and Breakout Session on Day 75: Issues NOT resolved by Day 89 Applicant may withdraw Final national decisions by Day 90 of procedure Examination by CG ± Artical 29 Referral to CHMP National authorisations Commission decision ,odels EU authorisations Figure 33.
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