CRED ERP 25

01/07/2025

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

25

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: P(roduct)L(ead) EMA

The Organisation for Professionals in Regulatory Affairs

26

Made with FlippingBook Ebook Creator