EMA überarbeitet Hinweise für Änderungen nach der Zulassung

Die European Medicines Agency (EMA) hat ihr Dokument "European Medicines Agency post-authorization procedural advice for users of the centralized procedure" überarbeitet. Die neuen und überarbeiteten Fragen und Antworten (Q&A´s) wurden am 11. Dezember 2017 veröffentlicht.

Die folgenden Q&A´s sind überarbeitet oder neu hinzugefügt worden:

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 (neu seit Juni 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? (neu)
• 16.14. What templates should I use for the RMP submission? (neu)
• 16.15. When and how will the RMP Summary be published on the EMA website? (neu)

Weitere Informationen finden Sie auf der EMA-Website unter Post-marketing authorization: Regulatory and procedural guidance.