Guidance

Supply unlicensed medicinal products (specials)

Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'

Documents

The supply of unlicensed medicinal products 'specials', MHRA guidance note 14

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The supply of unlicensed cannabis-based products for medicinal use in humans

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Details

This Medicines and Healthcare products Regulatory Agency (MHRA) guidance is for those who want to manufacture, import, distribute or supply unlicensed medicines for human use (also known as ‘specials’), including CBPMs

‘Specials’ are products which have been specially manufactured or imported for the treatment of an individual patient after being ordered by a:

  • doctor
  • dentist
  • nurse independent prescriber
  • pharmacist independent prescriber
  • supplementary prescriber

Persons authorised to procure unlicensed CBPMs in the UK are:

  • doctors on the GMC Specialist Register
  • specialist Importers with a Home Office import and Domestic licence and MHRA licence
  • registered pharmacies or retail pharmacy businesses (with Home Office Domestic licences, where appropriate)
  • licensed wholesale dealers for supply to the order of any of the above
Published 6 May 2014
Last updated 31 October 2018 + show all updates
  1. Updated to add guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered cannabis-based products for medicinal use in humans (CBPMs) known as 'specials'.
  2. First published.