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).

From:
Medicines and Healthcare products Regulatory Agency
Published
31 December 2020
Last updated
11 October 2022 — See all updates

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, 738 KB, 185 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.

Published 31 December 2020
Last updated 11 October 2022 + show all updates

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

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

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

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

  5. Update to post-Brexit protocols

  6. Updated the written confirmations for UK active substance manufacturers

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

  8. Updated register of written confirmations

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

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

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

  12. First published.

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