Working draft — Scientific review: pending | Regulatory review: pending | Not for external clinical or promotional use without independent verification
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PrescriberLast reviewed: April 2026

UK Regulatory Framework: Licensed Medicines, CBPMs and Specials

Give prescribers a clear UK governance framework.

Learning Objectives

Understand the difference between licensed cannabinoid medicines, CBPMs and pure CBD medicines
Understand why therapeutic CBD products are still medicines
Understand why unlicensed prescribing requires patient-specific justification
Understand why product classification must be confirmed for the exact product
Understand why the knowledge base must not imply access or prescription

Core Content

The UK regulatory landscape for cannabinoid medicines includes three distinct categories: licensed medicines, Cannabis-Based Products for Medicinal use (CBPMs), and pure CBD-only medicines prescribed under the Specials framework.

Each category has different regulatory requirements, prescribing obligations, and documentation standards.

Key Takeaways

  • 1Three UK categories: licensed medicines, CBPMs, and Specials/unlicensed
  • 2Pure CBD products remain medicines if used therapeutically
  • 3Product classification requires formal confirmation
  • 4Unlicensed prescribing requires documented patient-specific justification
  • 5The knowledge base must not imply access or prescription

Case Example

A prescriber asks whether NWPT-SM32300 can be prescribed as a CBPM. How should this be addressed?

Do not confirm or deny CBPM classification for NWPT-SM32300.

Explain that product-specific regulatory classification requires formal confirmation.

Note that pure CBD-only products with negligible THC may fall outside the CBPM controlled-drug framework.

Advise the prescriber to seek formal regulatory/legal confirmation for the specific product.

Knowledge Check

Q1. Which of the following is a licensed cannabinoid medicine in the UK?

Q2. What is required before prescribing an unlicensed cannabinoid medicine?

Downloadable Tools

UK regulatory pathway quick card

Decision flowchart for UK cannabinoid medicine categories

card

Specials prescribing checklist

8-step checklist for unlicensed medicine prescribing

checklist

Patient-specific justification template

Template for documenting clinical justification

template

Consent checklist

Checklist for informed consent documentation

checklist

Tools are provided as templates for clinical practice. Adapt to your clinic's specific requirements.

References

  1. [1]MHRA. The supply of unlicensed medicinal products (specials). MHRA Guidance Note 14.
  2. [2]NICE. Cannabis-based medicinal products. NG144. 2019.
  3. [3]GMC. Good practice in prescribing and managing medicines and devices. 2024.
  4. [4]Home Office. Scheduling of cannabis-based products for medicinal use. 2018.
Module 0: Source ControlModule 2: Pharmacology

This material is educational and non-promotional. It does not constitute medical advice, prescribing advice, or a recommendation to use any medicine. Any use of an unlicensed medicine requires patient-specific clinical justification, informed consent, monitoring, pharmacovigilance and compliance with applicable regulatory requirements.