Form

Medicines: variation forms for a manufacturer's licence

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

Published 22 November 2014
Last updated 5 August 2016 — see all updates

• From: Medicines and Healthcare products Regulatory Agency

Documents

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

MS Word Document, 50KB

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

MS Word Document, 50.5KB

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

MS Word Document, 395KB

Variation to an existing storage handling site - 14V

MS Word Document, 354KB

Variation to add a storage and handling site - 13V

MS Word Document, 353KB

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

MS Word Document, 384KB

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

MS Word Document, 297KB

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

MS Word Document, 805KB

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

MS Word Document, 955KB

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

MS Word Document, 345KB

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

MS Word Document, 355KB

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

MS Word Document, 109KB

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 5 August 2016 + show all updates

1. 5 August 2016

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

2. 10 February 2016

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

3. 22 November 2014

   First published.