Brexit: EMA aktualisiert Hinweise für erforderliche Maßnahmen für zentrale Zulassungen

Der Brexit wirft auch für die Inhaber zentraler Zulassungen zahlreiche regulatorische Fragen auf. Diese sind Gegenstand eines Questions-&-Answers-Papers (Q&As) und eines Dokuments der Europäischen Arzneimittelagentur EMA, das unter dem Titel „Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure” auf der EMA-Webpage verfügbar ist. Die Dokumente sollen Unternehmen helfen, Handlungsbedarf zu erkennen und rechtzeitig die notwendigen Maßnahmen einzuleiten, um die Verkehrsfähigkeit der betroffenen Produkte über den Brexit hinaus sicherzustellen.

Am 19. Juni 2018 hat die EMA aktualisierte Fassungen der beiden genannten Dokumente veröffentlicht. Das Brexit Guidance-Dokument wurde um folgende Fragen und die dazugehörigen Antworten ergänzt:

Variations:

• 2a. What variation(s) shall I submit in case of a change of Notified body (previously from UK) for a medical device included in the pack?
• 3a. When should I submit Brexit related type IA (“do and tell”) variations that have to be implemented before 30 March 2019?

Transfer of orphan designation:

• 5a. Is there any simplification possible in case of several transfers of orphan designations between the same sponsors? (for medicines for human use)

QPPV and the pharmacovigilance system:

• 7a. What do I need to take into account when I change the PSMF location from UK to a Member State within the Union (EEA)?
• 7b. What if Qualified Person’s for Pharmacovigilance (QPPV) back-up arrangements are in the UK (for veterinary medicines)?

Ongoing initial marketing authorization procedures:

• 10. How can I change the UK based applicant to a non-UK based applicant for an ongoing marketing authorization application?
• 11. Should I update my ongoing MA application with regards to other entities or activities currently located in the UK?

CHMP scientific opinion under Article 58:

• 12. Do I need to update the dossier for CHMP Scientific Opinion under Article 58 in light of UK’s withdrawal from EU? (for medicines for human use)

Paediatric investigation plans (PIP) and waivers

• 13. Do I need to change the UK-based addressee of a PIP or waiver decision? (for medicines for human use)

Contact point at the EMA:

• 14. Who should be my primary contact point at the EMA regarding Brexit related activities?

Impact on Rapporteurships:

• 15. How will the change of the Rapporteurs currently from UK be conducted? (siehe hierzu auch: EMA benennt neue Rapporteure für zentrale Zulassungen)

Product Information:

• 16. What Brexit-related changes to the Product Information can I include as part of other procedures affecting MA Annexes?

Official Control Authority Batch Release:

• 17. How should I notify the change of Official Medicines Control Laboratory (OMCL) currently in the UK?

National scientific advice issued by UK authorities:

• 18. How shall I reflect UK national scientific advice in submissions made after 29 March 2019?

In den “Q&As” der EMA zu Brexit-Aspekten wurden die Antworten auf folgende Fragen, die sich auf Humanarzneimittel beziehen, eingefügt:

• 19. What if my product is subject to Official Control Authority Batch Release (OCABR) and is currently tested by a UK Official Medicines Control Laboratory (OMCL)?
• 21. How does UK’s withdrawal from the Union affect the status of inspection outcomes by the UK competent authority?
• 24. How does UK’s withdrawal from the Union impact on the possibility to market a multi-country pack which includes the UK?
• 25. What if Qualified Person’s for Pharmacovigilance (QPPV) back-up arrangements are in the UK?