CRED 8 Presentations

01/07/2024

For the face-to-face meeting (and TCs) • Prepare minutes for yourself Maximise effectiveness of advice

• Do not expect to ask additional questions in the face-to face meeting

• Face-to-face is preferred to teleconference (and hopefully possible again in the near future…)

The Organisation for Professionals in Regulatory Affairs

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Pre-submission meetings (e.g at MEB)

For European application procedure (Centralised procedure, Mutual Recognition or Decentralised procedure) with the Netherlands acting as Rapporteur or as Reference Member State (RMS), the company may request a pre-submission meeting with the MEB prior to initiating the application procedure. The purpose of this meeting is to discuss details regarding the procedure with the Rapporteur or RMS. NO PRE-ASSESSMENT of the data/dossier Useful e.g in case of first MRP/DCP with NL as RMS These meetings cannot be used to receive scientific advice! See MEB website: Application procedure advisory meetings: https://english.cbg-meb.nl/topics/mah-application-procedure advisory-meetings

The Organisation for Professionals in Regulatory Affairs

20