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

In October and November, the European Medicines Agency (EMA) once more published on its website the updated and revised version of the "Questions & Answers (Q&A)" document related to questions before and during the submission of a centralised procedure.

Updates in October 2021

Changes and updates to the "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" document made in October 2021 concern the following paragraphs and topics:

  • Paragraph 2.2. How and when should the eligibility request be sent to EMA?

  • Paragraph 2.4. What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?

  • Paragraph 2.6. When should I submit my marketing authorisation application? 

  • Paragraph 2.7. How should I notify a change in the contact person and/or intended submission date of my application? 

  • Paragraph 2.8. Is my product eligible for an accelerated assessment?

Updates in November 2021

The changes and updates made in November 2021 relate exclusively to paragraph 2.9 How are marketing authorization application pre-submission interactions structured at the EMA? This section has been completely revised and includes new passages as well as adjustments to the questions and their wording. In addition, the sub-item 2.9.7 Summary Flow Chart has been completely deleted, so that the former item 2.9.8 MAA pre-submission meetings with the Rapporteurs is now presented as the new item 2.9.7 to follow the consecutive numbering.

It should be added that the latest version (of November 2021) again draws attention to the fact that as of November 2021 the use of the so-called "Organization Management Service (OMS)" is obligatory and that registration in this service should take place prior to submission of the registration.

The new version of the "Q&A" document for central procedures can be found under Topics before and during application.

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