Form

Medicines: application forms for a manufacturer licence

To apply for a manufacturer licence, complete the appropriate form. Applications for a manufacturer licence will be payable on invoice.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 14 July 2025 — See all updates

Documents

Application form for a new manufacturer/importer licence (MIA): human use

MS Word Document, 215 KB

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Investigative medicinal products

MS Word Document, 202 KB

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Specials manufacturer

MS Word Document, 475 KB

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Hospital exemption

MS Word Document, 865 KB

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Non orthodox practitioner application

MS Word Document, 843 KB

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Details

Forms include:

• full manufacturer/ importer licence
• specials manufacturer
• investigative medicinal product
• hospital exemption
• non-orthodox practitioner

Email your application form and any supporting documents to pcl@mhra.gov.uk

You can find out how to make an application in our detailed guide on manufacturer and wholesaler licences.

Published 18 December 2014

Last updated 14 July 2025 + show all updates

1. 14 July 2025

   Updated to add three documents: Application form for a new manufacturer/importer licence (MIA): human use, Investigative medicinal products, and Specials manufacturer

2. 14 May 2020

   Published a new version of the Specials manufacturer form. Reverted the application form for a new manufacturer/importer licence (MIA): human use , after this was mistakenly changed.

3. 14 May 2020

   Uploaded a new version of the Application form for a new manufacturer/importer licence (MIA): human use, with batch certification having being removed under 'site types' on page 2.

4. 4 April 2019

   Updated form for Specials Manufacturers added to the page.

5. 23 January 2019

   Updated form for a new manufacturer/importer licenses (human use)

6. 18 December 2014

   First published.