Pre-submission meeting request form for an application for a centralised marketing authorisation for
The European Medicines Agency (“the Agency”) emphasises the importance of pre-submission meetings with applicants. Pre-submission meetings are a vital opportunity for applicants to obtain procedural and regulatory advice from the Agency.
The pre-submission meeting usefully either takes place after the confirmation by the CVMP of the eligibility of the intended product for the centralised procedure or the consideration of the notification of intent to submit a marketing authorisation application triggering the appointment of rapporteur and co-rapporteur for the evaluation, or it can also be earlier when the future applicant wishes to receive early advice e.g. including information regarding the legal basis or eligibility.
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