Importing CBPMs into the UK

What counts as a CBPM

Cannabis based products for medicinal use (CBPMs) were moved to Schedule 2 of the Misuse of Drugs Regulations 2001 in November 2018. That means they can be prescribed in the UK, but they remain controlled drugs, and almost all of them are unlicensed medicines.

In practice this puts every product under two regimes at once: controlled drug rules overseen by the Home Office, and medicines rules overseen by the MHRA. A gap in either one stops the supply chain.

The licences in the chain

Bringing a CBPM into the UK normally relies on a business that holds a Home Office controlled drug licence for possession and supply, plus an import licence for each consignment. The same business, or a partner, also needs an MHRA wholesale dealer's licence covering the import of unlicensed medicines, and the MHRA must be notified before each unlicensed import.

Most brands and overseas producers do not hold these licences themselves. They work through licensed third parties, so the quality of those relationships is what an inspector will look at.

Product quality: GMP at source

The product has to be manufactured to GMP, and the importer needs evidence of it: a valid GMP certificate for the manufacturing site, a batch certificate of analysis and a clear chain back to cultivation. Cultivation is normally expected to follow GACP.

Specifications, stability data and labelling need to line up with what is actually being prescribed and dispensed. Weak documentation at source is the most common reason consignments are delayed.

Distribution: GDP in the UK

Once in the UK, storage and transport must follow GDP. That covers temperature control, secure storage for controlled drugs, qualified suppliers and customers, records, returns and recall procedures.

A quality agreement should set out who does what between the brand, the importer, the wholesaler and the dispensing pharmacy, including who is responsible for complaints, deviations and recalls.

Prescribing and supply

CBPMs can only be prescribed by doctors on the GMC Specialist Register and are dispensed through pharmacies. Promotion of unlicensed medicines to the public is not allowed, which shapes how brands can talk about their products.

Questions to ask your licensed partners

• Which licences do you hold, and do they cover this product, these activities and this site?
• How long do import licences and MHRA notifications take with you, and who prepares them?
• What GMP evidence do you need from the manufacturer before the first consignment?
• Who is responsible for each step under our quality agreement?
• How are deviations, complaints and recalls handled, and how quickly will we be told?
• When were you last inspected by the MHRA or the Home Office, and what came out of it?