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.

From:
Medicines and Healthcare products Regulatory Agency
Published
3 July 2014
Last updated
17 November 2023 — See all updates

Documents

Medicines: notes for applicants and holders of a manufacturer licence

PDF, 592 KB, 26 pages

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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
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.

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