EMA: Renewed Update of the Q&A Documents on "Centralised Procedures"

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In February 2022, the European Medicines Agency (EMA) published on its website the updated and revised versions of the Questions & Answers (Q&A) documents related to centralised marketing authorisation procedures. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The Q&A document "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" has been updated only in a few points. The latest version of the Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" - addressing questions that may be relevant after the marketing authorisation has been granted - contains some additions, revisions and innovations.

 The updated passages are listed below:

• Paragraph 4 Extension of marketing authorisation
         - 4.5. How shall I present my Extension Application?
  
  
• Paragraph 7 Classification of changes
      - 7.2.4. How should I submit a revised updated Certificate of Suitability (CEP)?
  
  
• Paragraph 23 Marketing status updates
       - 23.4. What information should be reported to the Agency on the marketing status of CAPs?
       - 23.6. How to report marketing status updates to the Agency for CAPs?
       - 23.10. When and how to report to the Agency actions taken in 3rd countries?
       - 23.11. What information does the Agency publish about the marketing status of EU medicinal products?

Question 23.10. is new and explains the procedure for marketing authorisation holders who hold marketing authorisations outside the European Economic Area (EEA) and wish to withdraw, suspend or not renew them.

The new versions of the "Q&A" documents for centralised procedures can be found at:

• Pre-authorisation procedural advice
  
• Post-authoristaion procedural advice