If you want to grow, import or distribute medical cannabis in the UK, there is no single "medical cannabis licence". You need a set of licences from two regulators, and the right set depends on what your business will actually do. This guide explains which licences apply, in what order, and where applicants usually get stuck.

Who regulates medical cannabis in the UK

Since November 2018, cannabis based products for medicinal use (CBPMs) have been Schedule 2 controlled drugs. That puts two regulators in charge:

  • The Home Office controls the drug itself. Anyone who possesses, supplies, produces, imports or exports a controlled drug needs a Home Office licence.
  • The MHRA controls it as a medicine. Anyone who manufactures, imports or wholesales medicinal products needs the matching MHRA licence and must meet Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP).

You need both. A Home Office licence without an MHRA licence, or the other way round, does not let you trade.

The licences, by business model

Importing finished products from overseas

This is the most common route into the UK market. Typically you will need:

  1. A Home Office controlled drug licence for your site, covering possession and supply of Schedule 2 drugs.
  2. A Home Office import licence for each consignment. Every shipment needs its own licence, matched to an export authorisation from the source country.
  3. The right MHRA licence. Most importers hold a wholesale dealer's licence, WDA(H). Importing from some countries also needs a manufacturer's licence covering importation, with a named person who certifies batches.
  4. A product made to EU GMP. The overseas manufacturer must be able to prove it, normally through a GMP certificate and audit evidence.

Wholesale and distribution inside the UK

If you buy from a UK importer and sell to pharmacies, you will need a Home Office controlled drug licence and a WDA(H), with a Responsible Person named on the licence and a GDP quality system that holds up at inspection.

Manufacturing or growing in the UK

UK manufacture of finished CBPMs needs an MHRA manufacturing licence and full GMP. Cultivating high THC cannabis needs a separate Home Office licence, and these are granted rarely and only with very strong security and a clear legitimate purpose.

What the Home Office looks at

Expect the application to be judged on:

  • Site security, usually backed by a police crime prevention officer's assessment.
  • Fit and proper people, with criminal record checks on directors and key staff.
  • A clear, legitimate business case showing who you will supply and why.
  • Record keeping that meets controlled drug register requirements.

Applications are made online, a compliance visit is normal before a licence is granted, and fees apply. Allow several months, not weeks.

What the MHRA looks at

For a WDA(H) the MHRA wants a working GDP quality system before you trade: written procedures, temperature control, supplier and customer qualification, deviation and CAPA handling, and a Responsible Person who has the knowledge and authority to run it. An inspection usually follows the application.

Where applicants get stuck

  • Applying in the wrong order. Premises, people and procedures need to be ready before either regulator inspects.
  • Overseas GMP evidence that does not hold up. A certificate alone is often not enough; you need audit evidence your importer can rely on.
  • Underestimating the Responsible Person role. The MHRA expects a real, active RP, not a name on a form.
  • Treating each shipment as routine. Per consignment import licences take planning, and a missing export authorisation stops a shipment.

Do patients need a licence?

No. Patients do not need a licence or a "medical cannabis card". In the UK, CBPMs can only be prescribed by a doctor on the GMC specialist register and dispensed by a pharmacy. The licences in this guide apply to businesses, not patients.

How Medicexum helps

We help cultivators, importers and distributors plan the right licence set, build the quality system the MHRA expects, prepare for Home Office and MHRA inspection, and set up EU GMP evidence for overseas supply. We do not hold licences ourselves or supply cannabis based products. See our EU GMP importation service or send us an email enquiry.