# Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a14ac8a1-59ec-4062-a740-c22c39c5e219
Type: Guidance
Published: December 31, 2020
Updated: January 2, 2025

> This regulatory guidance issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the documentation requirements for the trade of active pharmaceutical substances. Under the current regulatory framework, manufacturers based in Great Britain—including England, Wales, and Scotland—must secure a Written Confirmation for every shipment exported to the European Economic Area (EEA) or Northern Ireland. This measure ensures that exported materials adhere to strict quality and safety standards. Conversely, the guidance identifies specific exemptions for imports into Great Britain. Active substances originating from Northern Ireland or a list of approved countries, including the United States, Japan, South Korea, Brazil, Australia, Israel, and Switzerland, do not require a Written Confirmation. Northern Ireland remains aligned with European Union rules regarding the placement of manufactured goods on the market. To ensure compliance, businesses must obtain the necessary documentation for outbound shipments to the EEA and verify the origin of inbound materials to determine if they meet the criteria for exemption. As this document is a general regulatory guideline, it does not specify a particular company name, inspection dates, or individual violations, but rather serves as a mandatory framework for all industry participants to maintain legal supply chain operations.

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## Content

This guidance explains how to obtain a Written Confirmation for each shipment of Active Substances manufactured in Great Britain (England, Wales and Scotland) that is exported to the EEA or Northern Ireland. Importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation is accepted from the following list of countries: European Economic Area (EEA) countries USA Japan Republic of Korea Brazil Australia Israel 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.

## Attachments

- [Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain](/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland/written-confirmations-for-export-to-eea-and-northern-ireland-of-active-substances-manufactured-in-great-britain)
- [Register of Written Confirmations for UK active substance manufacturers ](https://assets.publishing.service.gov.uk/media/6776b00ae8ca4d66bc4c94a8/Register_of_Written_Confirmations_for_UK_active_substance_manufacturers.pdf)