Cannabis-based products for medical use in humans

Guidance on the supply, manufacture, importation, and distribution of unlicensed cannabis-based products for medicinal use in humans (CBPMs) in the UK.

Key points:

        1.        Regulatory Framework: CBPMs must comply with the Human Medicines Regulations 2012, requiring procurement by Specialist doctors registered with the GMC. Manufacturers, importers, and distributors need appropriate licenses from the MHRA and the Home Office.

        2.       Special Clinical Needs: CBPMs can only be prescribed when no licensed medication meets a patient’s unique needs. Prescriptions must specify product details, including THC/CBD content and supplier information.

        3.       Manufacturing and Quality Standards: CBPMs must adhere to Good Manufacturing Practices (GMP), and product quality should be verified through a Certificate of Analysis.

        4.       Import and Distribution: Importers must notify the MHRA before importing CBPMs, provide detailed product information, and maintain records. Distribution requires licensed dealers, and strict record-keeping applies.

        5.       Storage and Labelling: Unlicensed CBPMs must follow Schedule 2 controlled drug storage requirements. Labels should include product information, usage warnings, and storage instructions.

        6.       Pharmacovigilance: Any adverse drug reactions (ADRs) must be reported to ensure patient safety. The MHRA oversees enhanced monitoring of CBPMs due to limited available safety data.

Source: The supply of unlicensed cannabis-based products for medicinal use in humans, published March 2020.