Guidance: Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

Medicines Healthcare Products Regulatory Agency

November 24
14:47 2020

Register of Written Confirmations for UK active substance manufacturers

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email tell us what format you need. It will help us if you say what assistive technology you use.


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

From 1 January 2021 we will continue to accept importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation from the same list of countries as currently (European Economic Area (EEA) countries, USA, Japan, Republic of Korea, Brazil, Australia, Israel and 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.


For further information, please email our Customer Services Centre at or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Published 1 September 2020
Last updated 24 November 2020 +show all updates
  1. In preparation for the end of the transition period we have commenced publishing Written Confirmations to support export of Active Substances for Human Use to the EEA.

  2. First published.

Recent Comments

Follow Us on Twitter

Share This

Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: