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
  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.

Documents

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

MS Word Document, 215 KB

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Investigative medicinal products

MS Word Document, 202 KB

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Specials manufacturer

MS Word Document, 475 KB

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Hospital exemption

MS Word Document, 865 KB

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Non orthodox practitioner application

MS Word Document, 131 KB

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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.