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

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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