Question 1

What is MHRA compliance for medical cannabis in the UK?

Accepted Answer

Operators handling cannabis-based products for medicinal use (CBPMs) need a Wholesale Dealer's Licence (WDA(H)) under the Human Medicines Regulations 2012, with GDP quality systems, a named Responsible Person and Home Office controlled drug authorisations.

Question 2

How long does WDA(H) licensing take?

Accepted Answer

Typical timelines run 90–150 working days from application acceptance, depending on inspection scheduling and dossier quality. Medicexum prepares submissions designed to pass first inspection.

Question 3

What is the difference between a WDA(H) and a Manufacturer's Licence?

Accepted Answer

A WDA(H) covers the wholesale distribution of medicinal products in the UK supply chain: procuring, holding, supplying and exporting them. Brokering is a separate regime under Regulation 45A and applies only to products covered by a marketing authorisation. A Manufacturer's Licence is needed if you actually make, assemble, repackage or label medicinal products. For medical cannabis, most importers and distributors only need WDA(H), while cultivators, processors and manufacturers need the Manufacturer's Licence plus EU GMP compliance.

Question 4

WDA(H) vs MIA(IMP): which do I need for importing medical cannabis?

Accepted Answer

WDA(H) is the standard licence for importing and distributing licensed or unlicensed cannabis-based medicines for named-patient or commercial supply. MIA(IMP) is only for investigational medicinal products (IMPs) used in clinical trials or under special clinical trial arrangements. If you are importing commercial CBPMs or specials, WDA(H) is usually the correct route.

Question 5

Which MHRA licence do I need based on my business model?

Accepted Answer

Importer or distributor of finished CBPMs: WDA(H). UK manufacturer, cultivator, processor or laboratory producing cannabis medicine: Manufacturer's Licence. Clinical trial sponsor importing investigational cannabis products: MIA(IMP). Veterinary cannabis distributor: WDA(V). Almost all Schedule 2 cannabis operators also need a Home Office controlled drug licence alongside the MHRA licence.

Question 6

Do I need a WDA(H) if I only broker medical cannabis but never hold stock?

Accepted Answer

No. A WDA(H) is required to wholesale deal, which means procuring, holding, supplying or exporting medicinal product you own or hold. If you arrange transactions and never take possession, custody, control or title, you are not wholesale dealing. MHRA broker registration does not apply either: brokering under Regulation 45A reaches only products covered by a marketing authorisation, and cannabis based products for medicinal use are unlicensed specials. The position changes the moment you take stock or title, and it is different again for licensed cannabis medicines such as Epidyolex, Sativex or Nabilone, which do hold marketing authorisations.

Question 7

Do I need a Home Office controlled drug licence as well as an MHRA licence?

Accepted Answer

Yes. Cannabis-based products for medicinal use that are Schedule 2 controlled drugs require a Home Office controlled drug licence (and import/export licences where applicable) in addition to the MHRA licence. MHRA covers quality and distribution; the Home Office covers controlled-drug control and security.

Question 8

Do you handle MHRA inspection remediation?

Accepted Answer

Yes — we run gap audits, write CAPA plans, rebuild SOPs and train teams to close MHRA inspection findings within statutory deadlines.

Question 9

How often does the MHRA inspect wholesale licence holders?

Accepted Answer

MHRA inspections of WDA(H) holders are risk-based. New licence holders are typically inspected within 12 months of licence grant, and thereafter on a cycle of every 2–3 years for low-risk sites and every 12–18 months for higher-risk operations (including controlled drugs such as cannabis-based products for medicinal use). Significant findings, complaints or major changes to the site can trigger earlier for-cause inspections.

Question 10

How much does an MHRA licence cost?

Accepted Answer

For a Wholesale Dealer's Licence (WDA(H)) handling cannabis-based products, expect an MHRA new application fee of around £2,733, plus an annual periodic fee (typically £628–£1,884 depending on turnover and site risk) and inspection fees charged per inspector-day (currently £628 per day). Home Office controlled drug licensing and any required variations are additional. Full, current fees are published on gov.uk — Medicexum builds the licensing budget into the project plan.

Licence type	Who it applies to	Eligibility notes
WDA(H)	UK wholesalers and distributors that hold, own or supply cannabis based products for medicinal use (CBPMs) in the human supply chain.	Requires a GDP quality system, suitable premises, and a named Responsible Person. The main licence for non-import UK distribution of medical cannabis.
MIA(IMP)	Importers bringing investigational medicinal cannabis products or unlicensed specials into the UK for clinical trials or named-patient supply.	Needed where the product is an investigational medicinal product (IMP) or imported under the specials regime. Often tied to QP and clinical trial governance.
Manufacturer's Licence	UK sites manufacturing, assembling, repackaging or labelling CBPMs, including compounded pharmacy preparations produced at scale.	Requires EU GMP compliance, qualified person (QP) oversight, and validated processes. Applies to both licensed and unlicensed product manufacture.
WDA(V)	Veterinary wholesalers distributing cannabis-derived veterinary products.	Parallel to WDA(H) but for the veterinary medicines supply chain. Not normally used for human medical cannabis.
Home Office CD licence	Any operator importing, storing or distributing Schedule 2 controlled cannabis-based products.	Not issued by MHRA, but mandatory alongside WDA(H) for cannabis that is a controlled drug. Requires secure storage, records and destruction protocols.

MHRA compliance for UK medical cannabis.

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MHRA licence types and who they apply to

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