Guidance

Medicines: notes for applicants and holders of a manufacturer licence

Guidance to help applicants and licence holders get and maintain a manufacturer licence - MHRA guidance note 5.

Documents

Medicines: notes for applicants and holders of a manufacturer licence

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

This guidance covers:

  • the manufacturer licence and importing from a third county
  • how to apply for a licence
  • manufacturers’ and importers’ obligations
  • compliance with good manufacturing practice (GMP)
  • personnel
  • the qualified person
  • the production Manager
  • the quality controller
  • importing licensed medicines from third countries
  • inspection
  • regulatory action
  • fees
  • further information

Updates to this page

Published 3 July 2014
Last updated 17 November 2023 + show all updates
  1. Routine update of text following UK’s exit from the European Union.

  2. Updated 'Medicines: notes for applicants and holders of a manufacturer licence'

  3. First published.

Sign up for emails or print this page