CRED 8 Presentations

01/07/2024

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

The Organisation for Professionals in Regulatory Affairs

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

• a hearing, in the case that an intention of refusal of the application has been issued, or for MEB decisions the addressee is expected to object to. In a European application procedure this is also called a ‘break-out session (BOS)’ or ‘oral explanation’. In case NL = RMS and still has major objections at day 180 of a DCP: a BOS is offered to the applicant.

The Organisation for Professionals in Regulatory Affairs

50