Q-and-A List by EMA on the Centralised Procedure Extended

The European Medicines Agency EMA maintains a questions-and-answers list in which questions are clarified that are important in the context of the submission of an application for a marketing authorisation under the Centralised System. These FAQs are complemented or revised at irregular intervals or when the occasion arises. Not long ago 5 new questions were added to this list:

  • Can my medicinal product be submitted under the Centralised Procedure?
  • How and when is an enquiry for eligibility for the Centralised Procedure to be submitted?
  • According to which procedure are appointments to be made with the CHMP Rapporteur/Co-Rapporteur and their assessment teams?
  • Is my medicinal product entitled to an accelerated assessment?
  • When is the application for the marketing authorisation to be submitted?

This list consists of a total of 53 questions/answers and covers the essential topics in connection with the submission of an application for a marketing authorisation under the Centralised System. On the EMA website, this Q&A document can be found under the sections "Human Medicines" - "Application Procedures" - "Pre-submission Guidance" - "Questions & Answers". This link leads you directly to the document.

For enquiries during the preparation phase for the application for a marketing authorisation under the Centralised Procedure, the EMA has also published additional explanations, a mandatory pre-submission request form and an application form for a pre-submission meeting. The forms are also available in the section "Pre-submission Guidance" with corresponding links. The "Explanatory Note on the Pre-submission Request Form" can be found here.

Author:
Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)

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