Importing medicines into the United Kingdom

The regulator

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines across the United Kingdom. Under the Windsor Framework, the MHRA has licensed medicines for Northern Ireland on a UK-wide basis since 1 January 2025, and packs for the UK market carry a "UK Only" marking. The licences needed to import are summarised on the government's import a human medicine page, and medicines containing a controlled substance also need the Home Office.

Legal routes for unregistered medicines

A medicine without a UK marketing authorisation is called unlicensed. It can be supplied only under the exemption for specials in regulation 167 of the Human Medicines Regulations 2012, and it can be imported only by a UK licence holder that has notified the MHRA.

Specials under regulation 167

The MHRA's specials guidance says an unlicensed medicine may be supplied when no licensed medicine can meet the needs of an individual patient, and that those needs are clinical and decided by the prescriber responsible for the patient. MHRA Guidance Note 14 adds that cost, convenience or operational needs do not count, that an unlicensed product should not be used where an equivalent licensed product meets the need, that supply records are kept for five years and that individual specials must not be advertised.

The import notification

The importer needs a wholesale dealer's licence (WDA(H)) when the medicine comes from a country on the MHRA's approved country list, or a manufacturer's specials licence (MSL) when it comes from any other country. India is not understood to be on that list, so imports from India normally run through an MSL holder. The importer emails a notification of intent to import with the form, GMP and GDP evidence and evidence of special clinical need. The goods must not be imported if the MHRA objects within 28 days of acknowledging the notification, and for life-threatening emergencies the MHRA may assess it in 2 working days. The form guidance says quantities are usually capped at 25 packs per notification unless justified, and each manufacturer needs its own line.

Patients, trials and free supplies

Supply is made to the prescriber, hospital or pharmacy, which then dispenses to the patient. A supplier outside the UK cannot use this route to send a medicine to a patient's home. Investigational and comparator products follow the clinical trial framework, which was reformed on 28 April 2026. From 23 June 2026, VAT Notice 1004 zero-rates medicines supplied free of charge for NHS use under regulation 167 or for an MHRA authorised trial, including qualifying imports, when a valid certificate is held.

Documents a buyer usually needs

• MHRA notification acknowledgement, or confirmation that the MHRA does not object, held by the UK importer
• Prescriber letter describing the special clinical need and why no licensed product is suitable
• GMP certificate for the manufacturing site and GDP evidence for the supply chain
• Certificate of analysis or conformity for each batch, plus the label and patient information leaflet
• TSE compliance evidence where the product needs it
• Proforma invoice, commercial invoice and packing list with matching names and quantities
• Air waybill consigned to the UK licence holder, and a Home Office licence for controlled drugs

Timeline: a worked example

An NHS hospital pharmacy needs an unlicensed medicine made in India for a named patient with a rare condition. No UK licensed product meets the need.

Total: roughly 5 to 6 weeks for a standard notification and about 1 to 2 weeks for an urgent one. These are planning estimates, not published service times.

Shipping lanes from India

Direct passenger and freighter flights link Delhi, Mumbai, Bengaluru, Hyderabad, Chennai and other Indian cities with London Heathrow and other UK airports, so the flight itself is usually under a day. Express courier service is typically 3 to 6 days door to door, and air cargo with clearance is typically 4 to 8 days. These are typical estimates. The importer of record is the WDA(H) or MSL holder named on the notification, so the goods are consigned to that importer, not to the hospital or the patient.

FCA, CPT, CIP or DAP to the importer's licensed site are the usual terms. DDP is rarely suitable because the UK licence holder declares the goods and takes responsibility for them at import.

Practical tips for buyers

• Ask the specials importer to notify the MHRA before freight is booked, and ship only after the importer confirms it may proceed.
• Keep the product name, strength, pack size, manufacturer and quantity identical across the notification, invoice and packing list.
• Duty on HS 3004 medicines is 0 percent according to World Bank WITS data for the UK. HMRC lists the zero rate for prescriptions dispensed by a registered pharmacist, and VAT Notice 701/57 says other medicines are usually standard-rated, so expect 20 percent import VAT on a commercial import unless a relief applies. Ask a UK tax adviser.
• For Northern Ireland deliveries, ask the importer whether any separate step applies, because the form guidance still refers to imports into Northern Ireland from outside the EEA.
• Keep the clinical letter on file. The MHRA expects documentary evidence of special need to be available on request.