CRED 8 Presentations

01/07/2024

Key milestones in procedures

• All 3 procedures more or less same milestones for applicants: • Submission/validation (before day 0) • List of questions/preparation of responses (clock off period) • Possible further questions/finalisation procedure • In case of possible refusal: possibility of oral hearing So time tables of different procedures important!

The Organisation for Professionals in Regulatory Affairs

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Main contact during procedure

• National applications: different per MS. In case of application to MEB: casemanager (no direct contact with assessors) • MRP/DCP applications: different per MS. In case of application to MEB: casemanager (no direct contact with assessors) • Applications via centralised procedure: PTL EMA

The Organisation for Professionals in Regulatory Affairs

26