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MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active substances manufactured in Great Britain for use in the European Economic Area (EEA) and Northern Ireland and about special rules for getting permission to export certain drugs and medicines.

Guidance on: Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland

In this guidance, MHRA explains how to obtain a Written Confirmation for every shipment of Active Substances manufactured in Great Britain (England, Wales, and Scotland) and exported to the European Economic Area (EEA).

Great Britain is recognized as a Third Country for the export of Active Substances for human use to the EEA.

A Written Confirmation confirms that for a third country, exporting Active Substances to the EEA.

  • the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA.

  • the manufacturing plant is subject to regular inspections.

  • significant non-compliance events would be communicated to the EEA without delay.

Guidance on: Export Drugs and Medicines: Special Rules

This guidance details the special rules that need to be followed for special drugs and medicines such as Controlled drugs.

You need permission to export:

  • controlled drugs like opioids, certain stimulants or psychotropic substances

  • certain drugs that can be used in lethal injections outside the EU

  • medicines for humans or animals

Click this LINK to know How the ‘Written Confirmation’ process operates and this LINK to know the special rules that you need to know before Export Drugs and Medicines.


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