Guidance

Exporting active substances for medicines after Brexit

How the ‘Written Confirmation’ process for active substances manufactured in the UK will be handled if there’s a no-deal Brexit.

Documents

Register of Written Confirmations for UK active substance manufacturers

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Get ready for Brexit on 31 October 2019. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.

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This guidance explains how to obtain a Written Confirmation for each shipment of Active Substances manufactured in the UK that is exported to the EEA.

In a no-deal Brexit, we will continue to accept importation of active substances into the UK without a Written Confirmation from the same list of countries as currently (European Economic Area (EEA) countries, USA, Japan, Brazil, Australia, Israel and Switzerland).

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

Published 11 March 2019
Last updated 9 October 2019 + show all updates
  1. Updated the page title and summary to clarify that this guidance is about exporting active substances for medicines if there's a no-deal Brexit.
  2. Uploaded an updated version of API Written Confirmations document
  3. Updated the list of Written Confirmations
  4. Published an updated version of the Register of Written Confirmations for UK active substance manufacturers.
  5. Updated attachment - API Written Confirmation 23/08/19 PDF
  6. Updated written confirmations for UK Active Substance Manufacters
  7. Updated list of Written Confirmations.
  8. Updated the Register of Written Confirmations for UK Active Substance Manufacturers document
  9. Published an updated version of Register of Written Confirmations for UK Active Substance Manufacturers
  10. Published an updated Register of Written Confirmations for UK Active Substance Manufacturers.
  11. Updated Register of Written Confirmations for UK Active Substance Manufacturers
  12. Updated Register of Written Confirmations for UK Active Substance Manufacturers added to the page.
  13. Added short section (3.1.) about generation of Written Confirmation for biological products.
  14. Uploaded an updated version of the Register of Written Confirmations for UK active substance manufacturers
  15. First published.