Your
Bespoke
Pharma
Consultancy

BREXIT

  • Are you familiar with the guidance and its impact on your products?
  • What is the Unfettered Access Procedure?
  • What are the international routes available for applying for a new licence post Brexit?
  • Do you understand the term “Grandfathering” with respect to Community Marketing Authorisations?
  • Will the MHRA continue to allow multi-country packs?
  • Do I need a National Contact Person for PV?

Let us do the groundwork for you.

New MHRA guidance for industry should be followed from 1 January 2021. It replaces previously published guidance on what to do from the end of the transition period. Our Brexit review focuses on changes to Licencing and covers the following topics:

  • Existing MAs and New MAAs
  • MHRA approach to handling DCPs/ MRPs which are approved or pending
  • Centrally Authorised Products (CAPs)
  • Variations
  • Renewals
  • MAH and QPPV location
  • Packaging

Let us do the groundwork for you.

New MHRA guidance for industry should be followed from 1 January 2021. It replaces previously published guidance on what to do from the end of the transition period. Our Brexit review focuses on changes to Licencing and covers the following topics:

  • Existing MAs and New MAAs
  • MHRA approach to handling DCPs/ MRPs which are approved or pending
  • Centrally Authorised Products (CAPs)
  • Variations
  • Renewals
  • MAH and QPPV location
  • Packaging

Contact Us

For your complimentary Brexit overview.

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