Medical cannabis (CBMPs) has been legal in the UK since November 2018, prescribed by specialists on the GMC Specialist Register. The Home Office controls import licensing; MHRA regulates GMP and marketing authorizations. In practice, most access is via private prescribing — NHS funding remains tightly restricted.
Medical cannabis (CBMPs — Cannabis-Based Medicinal Products) became legal in November 2018 under an amendment to the Misuse of Drugs Regulations 2001. Cannabis is reclassified as Schedule 2, allowing prescription by specialists on the GMC Specialist Register. Recreational cannabis remains illegal (Class B).
Licensing — Who Can Operate
Importers require a Home Office Controlled Drugs import license (annual standing license) plus a per-shipment Schedule 2 import license from the DLCU. Wholesale distributors require an MHRA Wholesale Dealer's Authorisation (WDA(H)). Manufacturers require an MHRA Manufacturing Authorisation.
Prescription & Patient Access
Only specialists on the GMC Specialist Register may prescribe CBMPs. GPs cannot prescribe directly. In practice, the vast majority of CBMP prescribing is private — NHS access is theoretically available but NICE guidance has limited reimbursed indications to childhood epilepsy and MS spasticity in practice.
The Access Gap
A significant gap exists between legal availability (since 2018) and practical patient access. NHS England estimates only ~3% of eligible patients access CBMPs via NHS. Private prescribing clinics have grown substantially to fill this gap. This is a known policy tension — relevant for market sizing.
Product Standards
CBMPs must be standardised, quality-controlled medicinal products. Unlicensed products may be imported as 'specials' under MHRA exemption for named patients. Licensed products require full MHRA Marketing Authorisation. British Pharmacopoeia (BP) is the reference standard.
Key rule: Two separate licenses required — an annual standing CD import license AND a per-shipment Schedule 2 import license from the Home Office DLCU. Both must be current before any shipment departs.
Annual Standing CD Import License
Importers must hold a standing Controlled Drugs license from the Home Office DLCU covering cannabis import. This is renewed annually and covers the importer's general authority to import Schedule 2 substances. It does not authorize individual shipments.
Per-Shipment Schedule 2 Import License
Each individual shipment requires a separate import license from the Home Office DLCU. Application submitted online. Processing time approximately 10 working days. License specifies product, quantity, supplier, and expected shipment date. Urgent pathway available for named patient supply.
MHRA Wholesale Dealer's Authorisation
Importers distributing to pharmacies or other wholesalers must hold an MHRA WDA(H) covering cannabis. The WDA(H) names a Responsible Person (Import) — RPi — who certifies each batch for UK release. GDP compliance is mandatory.
Required Documentation per Shipment
Home Office annual CD license, Home Office per-shipment import license (original), Exporting country export authorization, Certificate of Analysis per batch, MHRA-recognized GMP certificate, GACP certificate, Airway bill / bill of lading, Commercial invoice.
Northern Ireland — Special Considerations
NI has unique status under the Windsor Framework. Some products destined for NI may follow EU supply chain rules rather than MHRA-GB rules. NI importers should seek specific legal advice on whether EU-GMP or MHRA-GB requirements apply to their specific product and supply chain.
Export from UK
UK manufacturers may export CBMPs. Home Office export license required per shipment. MHRA GMP certificates are recognized in MRA partner countries (EU, Australia, Canada, Switzerland, NZ, Japan, Israel). UK exporters benefit from strong bilateral regulatory recognition.
Post-Brexit key change: MHRA has its own GMP regime for Great Britain (England, Scotland, Wales). EU-GMP certificates are no longer automatically valid for GB supply — an MHRA-recognized certificate and UK Responsible Person (Import) are required.
MHRA GMP for Great Britain
Post-Brexit, MHRA issues its own GMP certificates for UK manufacturers. For imported products, MHRA maintains recognition agreements (MRAs) with the EU, Australia, Canada, Switzerland, Japan, New Zealand, and Israel. Certificates from these authorities are accepted by MHRA without further UK inspection.
UK Responsible Person (Import) — RPi
All batches imported into Great Britain must be certified by a UK Responsible Person (Import). The RPi is the UK equivalent of an EU Qualified Person for imports. They must be named on the importer's WDA(H) and are legally responsible for confirming each batch meets UK standards before release.
EU-GMP Certificates — Post-Brexit Status
EU-GMP certificates from EEA authorities (ANSM, IMB, PEI etc.) are recognised by MHRA under the UK-EU MRA. They remain valid for MHRA purposes. EU QP batch certification from EEA is NOT sufficient for GB release — a UK RPi must additionally certify each batch.
Israeli IMFA Certificates
Israel has a bilateral arrangement with MHRA for GMP recognition. IMFA-issued GMP certificates are recognised by MHRA for cannabis products. This makes Israeli-manufactured cannabis products well-positioned for the UK market without needing an additional EU certification step.
Northern Ireland — Dual Regime
NI remains under EU pharmaceutical law for certain purposes under the Windsor Framework. EU-GMP certificates and EU QP batch certification may be sufficient for NI-specific supply chains. This creates a complex dual-track situation requiring specialist legal advice for NI supply.
Note: MHRA requires GACP certification for all cannabis cultivation sites supplying the UK market. Both EU GACP and WHO GACP are accepted. Requirements are aligned with EU standards post-Brexit.
Accepted GACP Standards
MHRA accepts EU GACP (EMEA/HMPC/246816/2006) and WHO GACP 2003 for UK supply. Certification must be issued by an ISO 17065-accredited third-party certification body. Self-certification is not accepted by MHRA.
Recognized Certifying Bodies
ISO 17065-accredited bodies such as Bureau Veritas, SGS, Kiwa, and IQNET members are recognized. MHRA reviews accreditation on a case-by-case basis and does not maintain a public approved list. Certifying body accreditation credentials should be included with the MHRA WDA(H) application.
Certificate Validity & Renewal
GACP certificates are typically issued for 1–3 years. MHRA requires a current certificate for each import license application and WDA(H) renewal. No grace period is granted for expired certificates — supply must be paused until renewal is complete.
Chain of Custody Documentation
The GACP certificate must identify the specific cultivation site. The GMP certificate must reference the GACP-certified cultivation source. Any change in cultivation site — even within the same company — requires notification to MHRA and an updated certificate before UK supply can continue.
No documents yet
No regulatory documents available for this jurisdiction yet. We are expanding coverage — check back later.
Regulator Contacts
Home Office DLCU
Drugs Licensing and Compliance Unit — Controlled drug import/export licenses