GOV.UK
Form
Medicines: variation forms for a manufacturer's licence
- From:
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Licences to manufacture or wholesale medicines and Patient safety
- Published:
- 22 November 2014
- Last updated:
- 5 August 2016, see all updates
Forms to make a variation to a manufacturer's licence.
Documents
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 add a new site to a manufacturer’s licence – includes MIA, MS and MIA(IMP) - 10V
MS Word Document, 607KB
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, 354KB
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.
Document information
Published: 22 November 2014
Updated: 5 August 2016
- Updated v1V, 2V, 3V, 9V, 10V, 11V, 12V, 13V, 14V & 15V.
- Updated variation to add a contract laboratory site to an existing manufacturer’s licence/authorisation form.
- First published.