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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

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Details

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.

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk 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.

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