EMA revises Post-Authorization procedural Advice

Recommendation

4/5 September 2024
Munich, Germany

Quality Risk Management
An ICH Q9 Training Course

The European Medicines Agency (EMA) revised its post-authorization procedural advice for users of the centralized procedure. The new and revised Questions and Answers (Q&A´s) have been published on December 11, 2017.

The following Q&A´s have been revised or newly introduced:

1. Type IA Variations

1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?
1.6. Can my Type IA/ IAIN be part of worksharing?
1.8. What fee do I have to pay for a Type IA/ IAIN variation?
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)?

2. Type IB variations

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)?

8. Pre-submission queries service

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

15. Post-Authorisation Measures (PAMs)

15.2. What is a specific obligation [‘SOB’]?
15.16. Who should I contact if I have a question when preparing my application?

16. Risk Management Plan (New since June 2016)

16.1. When should I submit a new/updated RMP?
16.2. When is my RMP a stand-alone variation?
16.3. What if my application does not include an updated RMP?
16.4. Which variation classification will apply for my RMP updates?
16.5. Which changes can be included in an RMP update without the need for an additional variation?
16.6. Can I group my RMP updates?
16.7. How should I handle parallel RMP submissions?
16.8. How shall I present my RMP update?
16.9. Can I submit a version of the RMP after the Opinion to reflect the last minute changes made during the CHMP?
16.13. How and to whom shall I submit my RMP application? (New)
16.14. What templates should I use for the RMP submission? (New)
16.15. When and how will the RMP Summary be published on the EMA website? (New)

Further information can be found on the EMA Post-marketing authorization: Regulatory and procedural guidance website.