MHRA and Medical Cannabis: The UK Regulatory Framework

The Regulatory Framework

• Cannabis remains Class B under the Misuse of Drugs Act 1971
• CBPMs (Cannabis-Based Products for Medicinal Use) are Schedule 2 — prescribable by specialist clinicians
• Only specialists on the GMC Specialist Register can prescribe — GPs cannot prescribe directly
• Most CBPMs are supplied as unlicensed specials under the Named Patient framework

Medical cannabis regulation in the UK involves multiple overlapping frameworks — but the prescribing pathway is clear and increasingly well-established.

Import Authorisation and Licensing

• MHRA Import Authorisation required for each Schedule 2 product imported for UK prescribing
• Requires submission of quality dossier, EU-GMP certificates, and batch testing documentation
• Cannamedical Britannia is actively progressing through this pathway
• Only Epidyolex and Sativex have full MHRA product licences — but unlicensed specials pathway functions well for clinical use

The MHRA authorisation process is rigorous but well-defined. Companies with existing EU-GMP infrastructure are well-positioned to navigate it efficiently.