Guidance: Supply unlicensed medicinal products (specials)

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Medicines Healthcare Products Regulatory Agency

May 12

09:34 2023

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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

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

12 May 2023
Updated PDF for 'The supply of unlicensed medicinal products 'specials', MHRA guidance note 14'
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'.
6 May 2014
First published.