Medicines and controlled drugs compliance
Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.
Some goods cannot be wholesaled without a specific authorisation: alcohol needs AWRS approval, medicines need a Wholesale Dealer's Authorisation, veterinary medicines need a VMD authorisation, and controlled drugs need a Home Office licence. Tobacco and alcohol also carry excise duty and track-and-trace duties. Get the right authorisation before you trade — buying from or selling as an unapproved wholesaler is an offence.
Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.
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Most goods can be wholesaled freely. A few cannot: alcohol, tobacco, human and veterinary medicines and controlled drugs each need a specific authorisation before you trade, and some carry excise duty as well. These duties apply UK-wide. Get the right approval first — these regimes carry criminal sanctions for trading without one.
Any business that sells, offers or arranges the wholesale sale of alcohol to other businesses must be approved by HMRC under the Alcohol Wholesaler Registration Scheme (AWRS) before trading, and receives a Unique Reference Number. This catches brokers who never take physical possession of the stock. Trade buyers must check their supplier's URN against HMRC's online lookup — buying from an unapproved wholesaler is an offence.
Alcohol also carries excise duty. If you hold or move duty-suspended stock you need the appropriate warehouse approval and must operate the Excise Movement and Control System (EMCS); the duty structure by strength applies from August 2023. For the duty detail, see get approved and pay duty on alcohol.
Every business in the tobacco supply chain — wholesalers and storage facilities included — must obtain an Economic Operator ID and Facility ID from the UK ID issuer, scan unique identifiers and record movements. Tobacco also carries excise duty and must bear UK duty-paid fiscal marks; selling unmarked or illicit tobacco is a criminal offence.
For the full duty and track-and-trace detail, see meet your tobacco product, duty and track-and-trace obligations.
A business procuring, holding, supplying or exporting human medicines wholesale must hold a Wholesale Dealer's Licence — WDA(H) — from the MHRA, comply with Good Distribution Practice and name a Responsible Person. Brokering medicines without holding stock requires separate MHRA broker registration.
For the MHRA authorisation routes, see MHRA authorisation for medicines and medical devices.
Wholesale supply of veterinary medicines needs a Wholesale Dealer's Authorisation from the Veterinary Medicines Directorate, with Good Distribution Practice compliance and a qualified person.
Wholesale dealing in scheduled controlled drugs needs a Home Office controlled-drugs domestic licence in addition to the WDA(H), with secure storage and record-keeping under the Misuse of Drugs Regulations 2001 in Great Britain (Northern Ireland applies the equivalent Misuse of Drugs Regulations (Northern Ireland) 2002). For how the controlled-drugs schedules and licensing work, see medicines and controlled drugs compliance.
Make sure the cross-cutting duties for your business are in place — see Run a compliant wholesale business — then confirm everything with the wholesale compliance checklist.