EMA: Revised Q&A Document for Centralised Procedures

Recommendation

17/18 September 2024

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In February 2021, the European Medicines Agency (EMA) again published on its website an updated version of the Questions & Answers (Q&A) document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which was last revised in January 2021. These Q&As are intended as a guide and guideline for marketing authorisation holders and applicants of centralised procedures, in particular for topics that may be relevant after granting the marketing authorisation.

The latest version includes amendments and updates to chapters 1.Type IA Variations (paragraphs 1.4., 1.6., 1.10., 1.11. and 1.15.), 2.Type IB Variations (paragraphs 2.4., 2.11., 2.12. and 2.14.), 8.Pre-submission queries service (paragraph 8.2.) and 22. Article 61(3) Notifications (paragraphs 22.1., 22.3. and 22.6.).

As reported, the two "Q&A" documents for generic medicinal products and for questions prior to and during the submission of centralised procedures were also updated and published on the EMA website a few weeks ago (January 2021). The latest versions of these explanatory documents can be found at:

1) Generic/Hybrid Applications

2) Pre-Authorisation Procedural Advice