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Guidance: Notification of intent to import an unlicensed medicinal product

Medicines Healthcare Products Regulatory Agency

January 29
09:01 2025

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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.

Updates to this page

Published 18 December 2014
Last updated 29 January 2025 +show all updates
  1. 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. Updated the form notification of intent to import an unlicensed medicinal product

  3. Updated notification form added to the page.

  4. First published.

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