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. 17 November 2023

   Routine update of text following UK’s exit from the European Union.

2. 17 November 2023

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

3. 3 July 2014

   First published.