CRED ERP 25

4. Managing the Procedure: Pre-Submission to Approval

Procedure overview:

Pre-submission -18 months before start of procedure Submit invented names to Name Review Group (NRG) -6/7 months Eligibility Justification and Notification of Intent to File

Pre-submission meeting request EMA Pre-submission meeting

-6 months

Intent to submit multiple applications (Co-)Rapporteur and peer review appointed Intent to apply for (partial) fee waiver deferral Submission of MAA to EMA and (Co-)Rapporteur

-2 months

0

EMA Pre-submission meeting The meeting is intended to address issues peculiar to the planned MAA that have not been addressed in the Pre-Submission Guidance (PSG) Q&A document or other guidance. Assists applicants in “finalisation of upcoming MAA”. In order to apply for a meeting, applicants must complete the pre-submission meeting request form: https://www.ema.europa.eu/en/pre-submission-request-form

The form consists of the following areas: • Quality + GMP • Non-clinical + Clinical + GLP + GCP • Pharmacovigilance • Regulatory + procedural • Product information + transparency • Administrative

Information on the product and development programme should also be provided and using this information, the EMA will decide what needs to be discussed at the meeting.

Focus on key issues within dossier; try not to cover too many topics and ensure the company’s interpretation of the relevant legislation and/or guidance is provided along with the company position.