EMA revises Post-Authorization procedural Advice

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.

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