Importing unlicensed medicines into the UK: MHRA notification and specials

A medicine without a UK marketing authorisation is called unlicensed. The UK allows such a medicine to be supplied when no licensed product can meet an individual patient's needs, and it controls the import through a notification system run by the Medicines and Healthcare products Regulatory Agency (MHRA). The importer, not the overseas supplier and not the patient, carries the legal responsibility.

This guide covers the legal basis, the licence the UK importer needs, the notification steps and timing, and what an exporter in India provides. The United Kingdom import guide has the country summary, and how named-patient supply works explains the general model.

The legal basis: specials and special clinical need

Unlicensed medicines are supplied under the exemption in regulation 167 of the Human Medicines Regulations 2012. The MHRA's specials guidance says an unlicensed medicine may be supplied when there are no licensed medicines that can meet the needs of individual patients, that those needs are clinical, and that they are determined by the prescriber responsible for the patient's care. A special is made or imported for an individual patient after an order from a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber.

MHRA Guidance Note 14 adds four practical rules:

• Cost, convenience or operational needs are not special clinical needs.
• An unlicensed product should not be used where an equivalent licensed product can meet the need.
• Supply records are kept for at least five years.
• Individual specials must not be advertised.

Which licence the UK importer needs

The importer must hold one of two MHRA licences, and the choice depends on where the medicine comes from. The form guidance sets out the split.

The approved country list page was last updated on 22 December 2021. Because the list sits in a separate document, the importer should confirm India's status before relying on a WDA(H).

The MHRA notification, step by step

1. The prescriber confirms the need. A consultant or other prescriber writes a signed clinical letter describing the patient's special clinical need and why no licensed product is suitable.
2. The pharmacy places the order with a UK importer. The hospital or community pharmacy asks a WDA(H) or MSL holder to source the product.
3. The exporter supplies product evidence. A supplier in India provides the GMP certificate for the manufacturing site, a certificate of analysis or conformity for the batch, the label and the patient information leaflet, and TSE compliance evidence where relevant.
4. The importer notifies the MHRA. Under the notification guidance, the importer emails imports@mhra.gov.uk with the completed notification form, evidence of good manufacturing and distribution practice, evidence of special clinical need and, where appropriate, TSE evidence. Each notification names one finished-product manufacturer, and quantities are usually capped at 25 unless justified.
5. The MHRA acknowledges and assesses. Its letter may confirm no objection, ask for more information or object. Incomplete notifications may be rejected, and while a request for information is open the import must not proceed.
6. The import goes ahead. The goods may be imported unless the MHRA objects within 28 days of acknowledging the notification. For life-threatening or immediately injurious emergencies the MHRA may assess a notification in 2 working days.
7. The importer releases to the pharmacy. The importer delivers to the ordering pharmacy, which dispenses to the patient, and both keep their supply records.

Fees for import notifications are charged under the MHRA fee schedule rather than per email, so the importer should check the current MHRA fees page.

Timeline: a worked example

An NHS hospital pharmacy needs an unlicensed medicine made in India for a named patient with a rare condition, and 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. The lead-time estimator applies the same logic to other products. If the medicine is unapproved or new in India, the exporter's CDSCO export no objection certificate adds time, as explained in Indian export rules buyers should know.

Other UK routes worth knowing

Early Access to Medicines Scheme

The Early Access to Medicines Scheme (EAMS) gives patients access to a medicine before it has a UK marketing authorisation, for a life-threatening or seriously debilitating condition with high unmet need. It runs in two steps, a Promising Innovative Medicine designation and then a scientific opinion, which is valid for one year unless renewed. The applicant company supplies the product, so EAMS is a developer-led route rather than an import by a specials holder.

Clinical trials and comparators

Investigational and comparator products for an MHRA authorised trial follow the clinical trial framework, which was reformed by regulations in force from 28 April 2026. Import licensing for trial supplies should be confirmed with the sponsor before shipment. See comparator sourcing for clinical trials.

Northern Ireland

Since 1 January 2025 the MHRA has licensed medicines on a UK-wide basis. The notification form guidance still mentions imports into Northern Ireland from outside the EEA, so ask the importer whether any extra step applies to a Northern Ireland delivery.

Shipping, tax and controlled drugs

• Consignee. The goods are consigned to the WDA(H) or MSL holder named on the notification, not to the hospital or the patient. FCA, CPT, CIP or DAP to the importer's licensed site are the usual terms, and DDP is rarely suitable because the importer declares the goods. See Incoterms for pharmaceutical exports.
• Transit. Direct flights link several Indian cities with London, so courier service is typically 3 to 6 days and air cargo 4 to 8 days including clearance. For 2 to 8°C products, see cold-chain shipping of biologics from India.
• Matching documents. Product name, strength, pack size, manufacturer and quantity should be identical across the notification, invoice and packing list.
• Duty and VAT. Duty on HS 3004 medicines is reported at 0 percent, and a commercial import is usually charged 20 percent import VAT unless a relief applies. From 23 June 2026, VAT Notice 1004 zero-rates qualifying medicines supplied free of charge for NHS use under regulation 167 or for an authorised trial. The landed cost calculator shows the effect.
• Controlled drugs. A medicine containing a controlled substance also needs Home Office licensing (controlled drugs licences), and the Indian side needs a per-consignment export authorisation backed by the UK import licence.