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: 25 June 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

Plain Text, 51 KB

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

MS Word Document, 398 KB

Variation to an existing storage handling site - 14V

MS Word Document, 356 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, 387 KB

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

MS Word Document, 300 KB

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

MS Word Document, 681 KB

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

MS Word Document, 835 KB

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

MS Word Document, 216 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, 109 KB

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 25 June 2025 + show all updates

1. 25 June 2025

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

2. 5 August 2016

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

3. 10 February 2016

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

4. 22 November 2014

   First published.