EMA updates advice for users of the centralised procedure

The Europeans Medicines Agency (EMA) has updated its Q&A guidance on post-authorisation procedural advice for users of the centralised procedure. The revised sections are primarily related to Type IA and IB variations.

The following sections in the document on variations have been revised as of February 2021.

  1. Type IA Variations

1.4. How shall I present and submit my Type IA/IAIN variations(s)?

1.6. Can my Type IA/IAIN be part of worksharing?

1.10. What changes will trigger new EU number(s) (additional presentation(s))?

1.11. How to obtain new EU sub-numbers for Type IAIN variation concerning an additional presentation (e.g. new pack-size)?

1.15. Who should I contact if I have a question when preparing my application or during the procedure?

  1. Type IB variations

2.4. How shall I present and submit my Type IB Variation?

2.11. What changes will trigger new EU number(s) (additional presentation(s))?

2.12. How to obtain new EU sub-numbers for a Type IB variation concerning an additional presentation (e.g. new pack-size)?

2.14. Who should I contact if I have a question when preparing my application or during the procedure?

In addition, the following sections have also been revised during the latest update.

  1. Pre-submission queries service

8.2. How should I send queries to the pre-submission queries service?

  1. Article 61(3) Notifications

22.1. What are Article 61(3) Notifications?

22.3. When can I submit my 61(3) Notification?

22.6. How shall my 61(3) Notification be handled (timetable), and what could be the outcome?

To view the updated Q&A document in full, click here.