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Guidance

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland

How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
31 December 2020
Last updated:
2 January 2025
Show all updates

  1. Updated 'Register of Written Confirmations for UK active substance manufacturers'

  2. Updated 'Register of Written Confirmations for UK active substance manufacturers'

  3. Updated 'Register of Written Confirmations for UK active substance manufacturers' to August 2024.

  4. Updated 'Register of Written Confirmations for UK active substance manufacturers'.

  5. Updated the Written Confirmation PDF

  6. Updated 'Register of Written Confirmations for UK active substance manufacturers' .

  7. Updated 'Register of Written Confirmations for UK active substance manufacturers'

  8. Updated Register of Written Confirmations for UK active substance manufacturers

  9. Updated file "Register of Written Confirmations for UK active substance manufacturers"

  10. Updated Register of Written Confirmations for UK active substance manufacturers

  11. Updated 'Register of Written Confirmations for UK active substance manufacturers'

  12. Update to post-Brexit protocols

  13. Updated the written confirmations for UK active substance manufacturers

  14. Updated 'Register of Written Confirmations for UK active substance manufacturers'

  15. Updated register of written confirmations

  16. Updated Register of Written Confirmations for UK active substance manufacturers

  17. Published an updated version of the Register of Written Confirmations for UK active substance manufacturers.

  18. The Register of Written Confirmations for UK active substance manufacturers has been updated

  19. First published.

Documents

Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain

HTML

Register of Written Confirmations for UK active substance manufacturers

PDF, 2.4 MB, 187 pages

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Details

This guidance explains how to obtain a Written Confirmation for each shipment of Active Substances manufactured in Great Britain (England, Wales and Scotland) that is exported to the EEA or Northern Ireland.

Importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation is accepted from the following list of countries:

  • European Economic Area (EEA) countries
  • USA
  • Japan
  • Republic of Korea
  • Brazil
  • Australia
  • Israel
  • Switzerland

as well as from Northern Ireland.

Northern Ireland will also continue to align with all relevant EU rules relating to the placing on the market of manufactured goods.

Further guidance is available on importation of active substances from countries on a list.

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