Guidance

Supply unlicensed medicinal products (specials)

Updated 29 January 2025

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

Unlicensed medicines

Unlicensed medicines do not have a marketing authorisation in the UK and may not have been assessed by the MHRA.

Regulation 167 of the Human Medicines Regulations 2012 allows for unlicensed medicines to be supplied when there are no licensed available medicines that can meet the needs of individual patients.

The needs of individual patients must be clinical in nature and are determined by the prescriber responsible for their care.  

Unlicensed medicines may also be called ‘specials’.

Unlicensed medicines may be:

• Imported into the UK by the holder of a relevant license;
• Manufactured in the UK by the holder of a Manufacturer of Special’s License.

The MHRA has the following available guidance on:

• The supply of unlicensed medicinal products ‘specials’, MHRA guidance note 14
• The supply of unlicensed cannabis-based products for medicinal use in humans

Importing unlicensed medicines

If you want to import an unlicensed medicine into the UK you will need:

• a Manufacturer’s “Specials” Licence (MSL) if you’re importing a medicine from a country other than an approved country for import or, if you are in Northern Ireland, from outside the EEA
• a Wholesale Dealer’s Licence (WDA (H)) if you’re importing a medicine from an approved country for import.
• To notify the MHRA of your intent to import the unlicensed medicine before you import it.

Notifying the MHRA of intent to import an unlicensed medicine

A notification is submitted via e-mail to imports@mhra.gov.uk and has three elements:

• A completed notification submission form
• Complementary evidence of compliance with relevant medicine Good Manufacturing and Distribution Practices
• Complementary evidence of a special clinical need

See instructions for how to submit a notification of intent to import an unlicensed medicinal product.

Fees

Safety and quality vetting of unlicenced imported medicines fees are charged annually and retrospectively for the preceding financial year based on the total number of notifications of intent to import an unlicensed medicine and product codes you have submitted.

Please see MHRA fees for more information.

Manufacture of Unlicensed Medicines in the UK

Guidance for Manufacturing Specials (MS) licence holders in the interpretation of the GMP requirements to be applied when manufacturing unlicensed medicines is provided.

The document includes guidance on the appropriate standards for the manufacture of aseptically prepared products under an MS licence using essentially closed systems. However, it is important to recognise that all aseptically prepared products where open systems are used, should be manufactured in accordance with the standards outlined in the EU Guide, specifically Annex 1.

This guidance does not replace any of the requirements for unlicensed medicines already contained in Guidance Note 14 (GN 14).

The guidance in this document is for the manufacture of products under an MS licence. It is not intended to cover the importation of unlicensed products although many of the expectations are common. The general guidance within this document will also apply to radiopharmaceuticals.

This document does not contain any guidance relating to Advanced Therapy Medicinal Products which came into operation in December 2008 in accordance with European regulation No 1394/2007.

Manufacture of unlicensed ATMPs in the UK

Advanced therapy medicinal products: regulation and licensing in Great Britain

Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak

If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow the guidance for manufacturers specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak. 

Supply of unlicensed medicines between Northern Ireland and Great Britain

Once imported into the United Kingdom or manufactured in the United Kingdom, unlicensed medicines may be supplied between Northern Ireland and Great Britain (England, Wales and Scotland) without making additional notifications to MHRA.

The supplier in either territory may supply the unlicensed human medicine to a person authorised to receive a medicine (such as a doctor or a hospital), or to a wholesaler in the receiving territory.

The supplier will need to confirm that there is a special clinical need for use of the medicine which is unlicensed in the receiving territory.

Contacts

Submissions and queries regarding unlicensed medicines for human use: imports@mhra.gov.uk

For general enquires, refer to Contact MHRA

For exceptionally urgent cases that are out of office hours, contact the MHRA duty officer on 07795 641532.