EMA Procedural Advice Updates: Centralised Procedure

The European Medicines Agency (EMA) has updated its procedural advice documents for the centralised marketing authorisation procedure. The pre-authorisation and post-authorisation versions provide applicants and marketing authorisation holders with key requirements and practical procedural guidance in question-and-answer form. In parallel, the agency has updated several topic-specific Q&A pages.

Pre-Authorisation: Market Protection and Protection Periods

In the pre-authorisation document "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure", Chapter 6 ("Data exclusivity, marketing protection and market exclusivity") has been revised:

• Question 6.1.6: What are the protection periods for orphan medicinal products?
• Question 6.2.1: Extension of the ten-year period of marketing protection in the case of new therapeutic indications (8 + 2 + 1)

The complete document with tracked changes is available on the EMA website.

Post-Authorisation: Changes in Five Chapters

The post-authorisation document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure" has also been revised in several chapters:

Chapter 1, Type IA Variations

• Question 1.1: When shall I submit my Type IA/IAIN variation(s)?

Chapter 3, Type II Variations

• Question 3.8: How shall I present my application for a new or modified therapeutic indication?
• Question 3.11: How shall my Type II application be handled (timetable)?
• Question 3.13: Which post-opinion steps apply to my Type II variation and when can I implement the approved changes?
• Question 3.25: When will I get a PIP compliance statement?

Chapter 4, Extension of Marketing Authorisation

• Question 4.12: How shall my Extension Application be handled (timetable)?

Chapter 17, Periodic Safety Update Reports (PSURs)

• Question 17.30: How shall I implement the outcome of a PSUSA procedure?
• Question 17.35: What fee should I pay and whom should I contact if I have an issue related to the payment of the fee and QPPV advice notes?

Chapter 22, Article 61(3) Notifications

• Question 22.1: What is an Article 61(3) Notification?
• Question 22.3: When can I submit my 61(3) Notification?

The complete document with tracked changes is available on the EMA website.

Parallel Update of the Q&A Pages

The EMA has also revised the following topic-specific pages:

• Extensions of marketing authorisations: questions and answers
• Type IA variations: questions and answers
• Type II variations: questions and answers
• Periodic safety update reports (PSURs)
• Changing the labelling and package leaflet (Article 61(3) notifications)
• Accelerated assessment

The full documents and further details are available on the EMA websites under the Pre-Authorisation and Post-Authorisation sections.

Note for Applicants and Marketing Authorisation Holders

Applicants and marketing authorisation holders should check whether their ongoing or planned projects are affected, particularly for orphan medicinal products, Type II variations, PSUSA procedures, and Article 61(3) notifications. Internal SOPs, timelines, and submission processes should be reconciled with the amended questions and adjusted where necessary. The complete documents on the EMA website remain the authoritative source.