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.

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

This publication was withdrawn on 24 February 2020

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.

Published 11 March 2019
Last updated 16 January 2020 + show all updates

1. 16 January 2020

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

2. 16 December 2019

   Updated Written Confirmations for Active Substances manufactures in the UK list

3. 31 October 2019

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

4. 9 October 2019

   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. 30 September 2019

   Uploaded an updated version of API Written Confirmations document

6. 24 September 2019

   Updated the list of Written Confirmations

7. 24 September 2019

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

8. 23 August 2019

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

9. 22 July 2019

   Updated written confirmations for UK Active Substance Manufacters

10. 11 July 2019

    Updated list of Written Confirmations.

11. 18 June 2019

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

12. 3 June 2019

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

13. 20 May 2019

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

14. 25 April 2019

    Updated Register of Written Confirmations for UK Active Substance Manufacturers

15. 4 April 2019

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

16. 25 March 2019

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

17. 18 March 2019

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

18. 11 March 2019

    First published.