Guidance

Notification of intent to import an unlicensed medicinal product

How to submit a notification of intent to import an unlicensed medicine to the MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 29 January 2025 — See all updates

Documents

Notification of intent to import an unlicensed medicinal product

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Form: Notification of intent to import a medicinal product

MS Excel Spreadsheet, 38 KB

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Guidance on completing unlicensed medicine notification request form

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Details

This guidance provides information for individuals or organisations intending to import an unlicensed medicinal product into the United Kingdom. It outlines the legal requirements and the process for submitting a Notification of Intent to Import, including necessary documentation and compliance with regulatory standards.

The page offers information on how to notify the Medicines and Healthcare products Regulatory Agency (MHRA) of the importation, as well as key considerations regarding the safety, quality, and effectiveness of the product being imported. The notification process helps ensure that unlicensed medicinal products meet the required regulations for use in the UK.

Published 18 December 2014
Last updated 29 January 2025 + show all updates

1. 29 January 2025

   A new Guidance on the process for submitting notifications of intent to import an unlicensed medicine has been created. The Notification form has been updated and a new guide on how to complete the notification form has been added.

2. 12 March 2019

   Updated the form notification of intent to import an unlicensed medicinal product

3. 7 December 2016

   Updated notification form added to the page.

4. 18 December 2014

   First published.