EMAs Hinweise zu Verfahrensfragen nach erteilter Zulassung für Inhaber einer zentralen Zulassung
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Die europäische Arzneimittelagentur EMA hat ein aktualisiertes Q&A Dokument zu Verfahrensfragen, u.a. zum Vorgehen bei Änderungen nach erteilter Zulassung, für Nutzer des zentralisierten Verfahrens veröffentlicht. Fragen und zugehörige Antworten werden kontinuierlich aktualisiert und sind im Dokument mit "NEU" oder "Rev" mit entsprechendem Veröffentlichungsdatum gekennzeichnet.
Die integrierte Version beinhaltet folgende neue oder revidierte Fragen (inkl. Antworten):
2. Type IB variations
2.2. Is the (Co-) Rapporteur involed in Type IB Variations?
2.4. How shall I present and submit my Type IB Variation?
2.5. When shall I submit my Type IB Variation?
2.6. When do I need a linguistic review for changes in the product information? - NEU
2.7. How shall my Type IB variation be handled (timetable)?
2.9. Do I have to submit mock-ups and specimens?
2.10. How should I submit revised product information? In all languages?
2.14. What can be considered an editorial change and how can it be submitted as part of a type IA/IB/II variation?
2.15. Who should I contact if I have a question when preparing my application?
2.16. Who is my contact at the European Medicines Agency during post-authorisation procedures?
3. Type II variations
3.4. How shall I present my Type II Variation application?
3.11. When do I have to submit revised product information? In all languages?
4. Extension applications
4.12. When do I have to submit revised product information? In all languages?
9. Annual Re-assessment
9.3. How shall I present my annual re-assessment application?
10. Renewal
10.10. When do I have to submit revised product information? In all languages?
15. PSURs
15.2. What is the scope of PSUR assessment under the EU single assessment?
15.3. How shall I present my PSUR and in which format?
15.6. When do changes to the EURD list become legally binding?
15.16. Can I submit a clinical study report together with my PSUR? - NEU
15.17. What are the timelines for the submission of PSURs?
15.18. To whom should I submit my PSUR?
15.19. How will my PSUR submission be handled?
15.20. How shall I submit the Response to a request for Supplementary Information during a PSUSA procedure? - NEU
15.21. How is the CHMP opinion/CMDh position structured and which annexes need to be translated?
15.25. Who should I contact if I have a question regarding the preparation of a PSUR submission before a Procedure Manager is assigned?
15.26. Who should I contact if I have a technical issue with the submission of the PSUR? - NEU
15.27. Who should I contact if I have an issue related to the EURD list? - NEU
15.28. Who should I contact if I have an issue related to the payment of fee and QPPV advice notes? - NEU
15.29. Who is my contact at the European Medicines Agency during post-authorisation procedures?
Das Dokument ist auf der EMA Website hinterlegt und trägt den Titel "EMA post-authorisation procedural advice for users of the centralised procedure".
