Form

Medicines: variation forms for a manufacturer's licence

Forms to make a variation to a manufacturer's licence.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 November 2014
• Last updated: 9 September 2025 — See all updates

Documents

Breakdown of forms to be completed and time required for variations to manufacturer's licences - F3

MS Word Document, 52.5 KB

Breakdown of fees for variations to manufacturer’s licences - F2

MS Word Document, 18.5 KB

Variation to nominate site personnel – MIA, MIA(IMP) and MS - 15V

MS Word Document, 514 KB

Variation to an existing storage handling site - 14V

MS Word Document, 200 KB

Variation to add a storage and handling site - 13V

MS Word Document, 354 KB

Variation to an existing contract laboratory named on an existing manufacturer’s licence/authorisation - 12V

MS Word Document, 231 KB

Variation to add a contract laboratory site to an existing manufacturer’s licence/authorisation - 11V

MS Word Document, 144 KB

Variation to an existing process licence and/or authorisation: address - 3V

MS Word Document, 59.5 KB

Variation to an existing process licence and/or authorisation: basic company information - 2V

MS Word Document, 226 KB

Variation to an existing process licence and/or authorisation: cover letter - 1V

MS Word Document, 69 KB

Variation to an existing site named on a manufacturer’s licence – includes MIA, MS and MIA(IMP) - 9V

MS Word Document, 164 KB

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Variation to add a new site to a manufacturer’s licence – includes MIA, MS and MIA(IMP) - 10V

MS Word Document, 155 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

To apply for a variation to an existing manufacturer’s licence, complete the appropriate form(s) and send them to pcl@mhra.gov.uk.

You can make your payment when you receive the invoice.

Published 22 November 2014

Last updated 9 September 2025 + show all updates

1. 9 September 2025

   Updated the following files: Variation to an existing storage handling site - 14V Variation to add a contract laboratory site to an existing manufacturer’s licence/authorisation - 11V Variation to an existing process licence and/or authorisation: address - 3V Variation to nominate site personnel – MIA, MIA(IMP) and MS - 15V Variation to an existing process licence and/or authorisation: cover letter - 1V Variation to an existing contract laboratory named on an existing manufacturer’s licence/authorisation - 12V

2. 14 July 2025

   Changed to add updated documents: Variation to add a new site to a manufacturer’s licence – includes MIA, MS and MIA(IMP) - 10V and Variation to an existing site named on a manufacturer’s licence – includes MIA, MS and MIA(IMP) - 9V

3. 25 June 2025

   Updated attachment: Breakdown of fees for variations to manufacturer’s licences - F2

4. 5 August 2016

   Updated v1V, 2V, 3V, 9V, 10V, 11V, 12V, 13V, 14V & 15V.

5. 10 February 2016

   Updated variation to add a contract laboratory site to an existing manufacturer’s licence/authorisation form.

6. 22 November 2014

   First published.