- Home Office — DLCU — Controlled drugs licensing
Drugs Licensing and Compliance Unit. Issues all controlled drug import/export licenses, manufacturer and distributor licenses for Schedule 2 substances including cannabis.
- Per-shipment import/export licenses
- Standing CD licenses for manufacturers and distributors
- Enforcement of Misuse of Drugs Act 1971
- MHRA — Medicines regulation
Medicines and Healthcare products Regulatory Agency. Regulates GMP, GDP, clinical trials, and marketing authorizations. Issues WDA(H) wholesale dealer authorizations.
- GMP inspections of UK manufacturers
- WDA(H) for wholesale distribution
- Marketing Authorization (MA) or Specials license
- NHS England / NICE — Commissioning & HTA
NHS England commissions CBMP prescribing. NICE provides health technology assessment guidance. Funding decisions affect patient access significantly.
- NICE guidance affects NHS funding decisions
- Individual Funding Request (IFR) pathway for unlicensed
- NHS England Specialised Commissioning for complex cases
- NHS Scotland / SMC — Scottish Medicines Consortium
Devolved medicines commissioning for Scotland. SMC assesses medicines independently of NICE. Scotland has its own prescribing pathway for CBMPs.
- SMC assessment independent of NICE
- Scottish formulary decisions may differ from England
- NHS Wales / AWMSG — All Wales Medicines Strategy Group
AWMSG provides independent guidance for Wales. Welsh prescribing decisions may differ from England and Scotland.
- AWMSG assessment for NHS Wales funding
- Separate formulary from England
- HSCNI — Northern Ireland
Health and Social Care Northern Ireland. Post-Brexit, NI has unique status — may follow EU or UK rules depending on product type. Ongoing regulatory divergence.
- NI Protocol creates dual regulatory exposure
- Some EU rules may apply to NI-specific supply chains
- Licensed Pharmacies / Specials — Dispensing
Pharmacies dispense against specialist prescriptions. Unlicensed imports may be dispensed as 'specials' under MHRA exemption. Licensed CBMPs dispensed normally.
- Specialist Register prescriber required
- Schedule 2 CD register at pharmacy
- Named patient import via specials route if no MA
- Patients — End recipients
Receive CBMPs via specialist prescription. Private prescribing is more common than NHS — NHS funding remains very restricted in practice despite legal access since 2018.