Brand ownership and specification
Defining brand materials, specifications and reference documentation.
Approach
Compliance first, not compliance later.
Quality and governance systems designed ahead of trading activity.
The framework
Prescribed, unlicensed, and tightly controlled
Cannabis based products for medicinal use have been available on prescription in the UK since November 2018. They remain unlicensed medicines, supplied under regulation 167 of the Human Medicines Regulations 2012, and can only be prescribed by a specialist doctor on the General Medical Council Specialist Register.
Our operating model
Responsibilities are separated and documented across the partner network.
Licensed partner network
Working through organisations that hold permissions for their regulated activities.
Prescriber and pharmacy relationships
Maintaining factual professional relationships within the regulated supply framework.
Partner permissions
What our partners hold
| Activity | Permission held | Issued or assessed by | What we verify |
|---|---|---|---|
| Cultivation | Good Agricultural and Collection Practice (GACP) | Competent authority in the country of cultivation | Scope, current status and expiry |
| Manufacture and batch release | EU-GMP manufacturing authorisation | National competent authority | Authorisation scope, site and dosage forms covered |
| Handling of controlled drugs | Home Office controlled drugs licence | Home Office | Licence class and the schedules covered |
| Wholesale distribution | Wholesale Dealer's Licence for human medicines, WDA(H) | MHRA | Licence scope and the named Responsible Person |
| Dispensing | Registered pharmacy | General Pharmaceutical Council | Registration status and Superintendent Pharmacist |
| Prescribing | Clinic registered with the relevant care regulator, prescriber on the GMC Specialist Register | Care Quality Commission and equivalent regulators, General Medical Council | Registration status |
Cultivation
- Permission held
- Good Agricultural and Collection Practice (GACP)
- Issued or assessed by
- Competent authority in the country of cultivation
- What we verify
- Scope, current status and expiry
Manufacture and batch release
- Permission held
- EU-GMP manufacturing authorisation
- Issued or assessed by
- National competent authority
- What we verify
- Authorisation scope, site and dosage forms covered
Handling of controlled drugs
- Permission held
- Home Office controlled drugs licence
- Issued or assessed by
- Home Office
- What we verify
- Licence class and the schedules covered
Wholesale distribution
- Permission held
- Wholesale Dealer's Licence for human medicines, WDA(H)
- Issued or assessed by
- MHRA
- What we verify
- Licence scope and the named Responsible Person
Dispensing
- Permission held
- Registered pharmacy
- Issued or assessed by
- General Pharmaceutical Council
- What we verify
- Registration status and Superintendent Pharmacist
Prescribing
- Permission held
- Clinic registered with the relevant care regulator, prescriber on the GMC Specialist Register
- Issued or assessed by
- Care Quality Commission and equivalent regulators, General Medical Council
- What we verify
- Registration status
Governance
Defined oversight
Board Regulatory and Compliance Committee
Board level review of regulatory readiness, compliance matters and key decisions.
Project Steering Committee
Cross functional coordination of development activity, dependencies and actions.
Weekly Risk review
A scheduled review of identified risks, owners, controls and open actions.
Regulatory review
Keeping the model current
The operating model is reviewed as requirements and partner permissions change.
Partner licences and permissions are verified and kept under review.
Technical agreements and product specifications are version controlled.
Changes affecting the supply chain are managed through change control.
Regulatory developments relevant to cannabis-based products for medicinal use are monitored.
Information for healthcare professionals
Product reference information is available to UK healthcare professionals qualified to prescribe or supply medicinal products. It is released on request and is factual reference material, not promotional material.
Healthcare professionals