CRED ERP 25

01/07/2025

Recommendations

• Make sure that you submit the applications on the date as agreed with the NCA when asking for a submission slot/requesta submission slot that is feasible for you • Ensure availability of relevant experts (especially when timelines are short, e.g. near the end of the procedure); • Respond to all questions / address all comments seriously/agree on timelines when the NCAs will receive the responses

• Be pro-active / anticipate;

• If comments are not clear: consider requesting a clarification meeting.

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Clarification meetings – MEB (national applications) (1/2)

MEB policy Clarification meeting and hearing (see MEB website): • In addition to routine contact between MEB case managers and the company during the course of an application procedure for marketing authorisation or subsequent amendment, there are two other possibilities for interaction: • a clarification meeting, during which the company can request further clarification of the questions asked by the MEB

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