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'

• From: Medicines and Healthcare products Regulatory Agency
• Published: 6 May 2014
• Last updated: 12 May 2023 — See all updates

Documents

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

PDF, 527 KB, 21 pages

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

PDF, 795 KB, 22 pages

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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

We have published guidance for manufacturers specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak.

Published 6 May 2014
Last updated 12 May 2023 + show all updates

1. 12 May 2023

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

2. 31 October 2018

   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'.

3. 6 May 2014

   First published.