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 May 2020 — See all updates

Documents

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

MS Word Document, 957KB

Investigative medicinal products

MS Word Document, 951KB

Specials manufacturer

MS Word Document, 752KB

Hospital exemption

MS Word Document, 581KB

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, 372KB

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 (MS Word Document, 1.03MB)
• specials manufacturer (MS Word Document, 871KB)
• investigative medicinal product (MS Word Document, 994KB)
• hospital exemption (MS Word Document, 1.21MB)
• non-orthodox practitioner (MS Word Document, 372KB)

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 May 2020 + show all updates

1. 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.

2. 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.

3. 4 April 2019

   Updated form for Specials Manufacturers added to the page.

4. 23 January 2019

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

5. 18 December 2014

   First published.