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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.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
11 March 2019
Last updated:
16 January 2020
Show all updates

  1. Uploading of updated Register of Written Confirmations for UK active substance manufacturers PDF.

  2. Updated Written Confirmations for Active Substances manufactures in the UK list

  3. We have updated the Register of Written Confirmations for UK active substance manufacturers document

  4. 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.

  5. Uploaded an updated version of API Written Confirmations document

  6. Updated the list of Written Confirmations

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

  8. Updated attachment - API Written Confirmation 23/08/19 PDF

  9. Updated written confirmations for UK Active Substance Manufacters

  10. Updated list of Written Confirmations.

  11. Updated the Register of Written Confirmations for UK Active Substance Manufacturers document

  12. Published an updated version of Register of Written Confirmations for UK Active Substance Manufacturers

  13. Published an updated Register of Written Confirmations for UK Active Substance Manufacturers.

  14. Updated Register of Written Confirmations for UK Active Substance Manufacturers

  15. Updated Register of Written Confirmations for UK Active Substance Manufacturers added to the page.

  16. Added short section (3.1.) about generation of Written Confirmation for biological products.

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

  18. First published.

This publication was withdrawn on

For current information on Exporting active substances for medicines see Good manufacturing practice and good distribution practice

Documents

Written Confirmations for export of Active Substances manufactured in the UK

HTML

Register of Written Confirmations for UK active substance manufacturers

PDF, 926 KB, 186 pages

Details

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.

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