Centralised Procedures: Q&A Documents also Updated for Biosimilars

In February 2025, the "Questions & Answers (Q&A)" documents relating to centralised procedures including biosimilars were updated once again and published on the website of the European Medicines Agency (EMA).

The list of questions relating to topics prior to and during the application process for a centralised procedure, which is called "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure", has been supplemented and updated with the following items:

Chapter 2 Steps prior to submitting the application

In Chapter 2, the response texts of the passages "2.4.1.1. Requesting the appointment of CHMP/PRAC/CAT Rapporteurs/Co-Rapporteurs and their assessment teams", "2.4.2.2. Generic/hybrid medicinal products" and "2.4.2.3.Similar biological medicinal products" have been revised and updated.

The subsection "2.4.2.4. Non-prescription medicinal products" has been completely deleted, so that the numbering for the following two subsections has also been adjusted. As a result, the passage "Re-examination of a CHMP opinion" (formerly 2.4.2.5.) can now be found under 2.4.2.4. and the subsection "Ancillary medicinal substances or ancillary human blood derivatives incorporated in medical devices" (formerly 2.4.2.6.) under 2.4.2.5.

The questionnaire "European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications", which deals with subjects relating to the submission of applications for biosimilars as part of a centralised procedure, has been supplemented and updated with the following points:

Chapter 2 Steps prior to submitting the application

The answer text to the question "2.3 When and how Rapporteur and Co-Rapporteur appointed?" has been significantly revised and updated.

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

• Topics prior to and during the application process
• Topics for biosimilar applications