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Brexit: EMA updates information for holders of centralized marketing authorizations

07/08/2018

According to the European Medicines Agency (EMA), marketing authorization holders (MAHs), applicants and sponsors of centrally authorized medicines for human or veterinary use should consider how Brexit will impact their medicines and which changes need to be addressed before the UK leaves the EU. They also need to ensure that the necessary changes are made by that date.

Brexit-related regulatory questions for holders of centralized marketing authorizations are therefore the subject of a Questions & Answers Paper (Q&As) and a document entitled "Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure" available on the agency's website. The documents are provided to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). EMA is preparing a series of further Brexit-related guidance which will be published on its website. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit.
On June 19, 2018, the EMA published updated versions of the two mentioned documents. The Brexit Guidance Document has been supplemented by the following questions together with the corresponding answers:

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:

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 addition, EMA´s “Q&A” paper regarding aspects of the Brexit has been amended by the following with regard to medicines for human use:

  • 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?