EMA: Q&A document for "Centralised Procedures" updated again

In June 2024 the Q&A documents relating to centralised marketing authorization procedures were updated again and published on the website of the European Medicines Agency (EMA). These Q&A catalogues are intended to provide assistance and guidelines for Marketing Authorization Holders and applicants for centralised procedures and provide answers to possible questions at different stages of the centralised marketing authorization application.

The catalogue of questions (European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure) relating to topics before and during the application of a centralised procedure has been supplemented or updated by the following points:

Chapter 1 Types of applications and applicants

Paragraph "1.11. In which exceptional cases are combination packs permitted in the centralized procedure and where can I submit my application for review?" has been updated and divided into three subsections.

Chapter 2 Steps prior to submitting the application

In Chapter 2, the subsection "2.4.1.2 Declaration of a device within the scope of the Joint Clinical Assessment (JCA) according to the HTA Regulation (Regulation (EU) 2021/2282) in the Letter of Intent" has been added. Furthermore, the answers to the questions "2.7. How should I notify a change of contact person and/or planned submission date for my application?" and "2.10. How should I notify the Agency if I no longer wish to pursue my application?" have been updated and supplemented.

Chapter 3 Preparing the dossier

In section 3.4 Compliance, Environmental Risk Assessment and Pharmacovigilance, the question "3.4.1 Which information do I need to provide in my marketing authorization application regarding GMP / GLP compliance and GCP Inspection?" and its answer have been updated.

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 marketing authorization, contains some additions and revisions in the following passage:

Chapter 19 Transfer of Marketing Authorisation

There have been updates to the following questions: 

• 19.2 How shall I present my application for the Transfer of Marketing Authorization?
• 19.5 How to choose the implementation date?

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

• Topics before and during the application
• Topics after the authorization is granted