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March 4, 2026
Approximately 5 minutes
MHRA Guidance on Supplying Unlicensed Medicinal Products (Specials) in the UK
MHRA Guidance on Supplying Unlicensed Medicinal Products (Specials) in the UK
1. Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines in the UK, ensuring licensed products meet standards. This guidance covers unlicensed medicinal products ('specials') manufactured or imported for individual patients ordered by authorized prescribers. Unlicensed medicines are exempt from marketing authorization under Regulation 167 of the Human Medicines Regulations 2012 if they meet specific conditions. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
2. Special Needs
Unlicensed products may only be supplied to meet the special clinical needs of individual patients, determined by the prescriber. If a licensed product can meet the need, even off-label, it should be used instead. Special needs include intolerances or allergies, not cost or convenience. Suppliers must verify the existence of special needs and maintain documentary evidence. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
3. Persons Authorised to Procure Specials
Authorized persons include registered doctors, dentists, supplementary prescribers, nurse or pharmacist independent prescribers, hospital pharmacists, wholesale dealers, and licensed manufacturers. Suppliers should confirm the professional status and special need. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
4. Manufacture and Assembly in the UK
Manufacturers must hold a Manufacturer’s 'Specials' Licence, complying with GMP. Operations are inspected, requiring qualified staff like a quality controller and production manager. Release is by the quality controller. Compliance with TSE regulations is required. Guidance on labelling follows British Pharmacopoeia monographs. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
5. Importation into the UK
Importers need a Manufacturer’s 'Specials' Licence for imports from non-approved countries or a Wholesale Dealer’s Licence for approved countries. Notifications to MHRA are required before import, including forms, GMP/GDP evidence, and proof of special need. Fees are charged annually based on notifications. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
6. Distribution
Wholesale dealers must hold a Wholesale Dealer’s Licence, complying with GDP. They can supply specials to authorized persons, ensuring the supply chain maintains product quality. Records must be kept for traceability. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
7. Advertising
Advertising of unlicensed specials is prohibited under Regulation 279 of the Human Medicines Regulations 2012. Promotional activities must not imply efficacy or safety assessments beyond what's required. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
8. Obligations on Persons Who Sell or Supply
Suppliers must ensure products are supplied only in response to bona fide unsolicited orders for special needs. Records of transactions must be kept for five years, including details of prescribers and patients where applicable. Pharmacovigilance obligations require reporting adverse reactions. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
9. Export to Other EU/EEA Member States
Exports require compliance with destination country's regulations. Specials cannot be exported if a licensed equivalent exists in the UK. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
10. European Court Cases
Relevant cases like Commission v Poland emphasize that specials exemptions are strictly for individual special needs, not systematic supply. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
11. Further Information
Contact MHRA for queries. Additional guidance on hierarchy for unlicensed medicines use is in Appendix 2. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
12. Glossary of Legislation
Includes Human Medicines Regulations 2012 and related directives. https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf
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