Centralised Procedures: Q&As Updated

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

The list of questions relating to topics before and during a centralised procedure application "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" was supplemented or updated with the following points:

Chapter 1 Types of applications and applicants

In Chapter 1, the paragraphs relating to question "1.3. What special support is available for micro, small and medium-sized enterprises (SMEs)?" were updated and renewed.

Chapter 2 Steps prior to submitting the application

In Chapter 2, the answer text for paragraph "2.7. How should I notify a change in the contact person and/or intended submission date of my application?" was added.

Chapter 3 Preparing the dossier

Here, the answers to the two questions "3.2.1. Do I need to address any paediatric requirements in my application?" and "3.2.2. What aspects should I consider if my medicinal product has been designated as an orphan medicinal product at the time of submission of my application?" were extended and revised.

Chapter 4 Submission, validation and fees

In Chapter 4, the answer to question "4.1. How and to whom should I submit my dossier?" in paragraph "Working documents outside the eCTD structure" was shortened.

The new version of the Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which addresses issues that may be relevant after the marketing authorisation has been granted, contains fundamental additions, abbreviations and revisions in the following chapters and their questions:

• Chapter 1 Type IA Variations
• Chapter 2 Type IB variations
• Chapter 3 Type II variations
• Chapter 4 Extension of marketing authorisation
• Chapter 5 Grouping of variations
• Chapter 6 Worksharing of variations
• Chapter 13 Post Authorisation Safety Study (PASS)
• Chapter 17 Periodic Safety Update Reports (PSURs)
• Chapter 23 Marketing status updates and withdrawals

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

• Topics before and during the authorisation process
• Post-authorisation topics