By the PharmaTradz BD Team. Published October 2026.
An unlicensed medicine in the UK is any medicinal product that does not hold a UK marketing authorisation (the licence that lets a medicine be sold after the MHRA, the Medicines and Healthcare products Regulatory Agency, has assessed it). The law still allows these products to be supplied, but only to meet the special clinical needs of an individual patient, on the order of a prescriber. Most are known as specials: products made in the UK under a specials licence, or imported for a named need. This guide explains the rules, who may supply them and what overseas manufacturers need to provide.
What counts as an unlicensed medicine
The key test is simple: does the product have a marketing authorisation valid in the UK? If not, it is unlicensed. In practice, buyers meet three broad groups:
UK-made specials are made by a holder of a manufacturer's "specials" licence (often called an MS licence). Typical examples are oral liquids for children or patients who cannot swallow tablets, or unusual strengths. The MHRA licenses and inspects the manufacturer, but it does not assess each product for quality, safety and efficacy.
Imported unlicensed medicines are products brought into the UK for patients when no suitable UK product exists. Many are licensed in their country of origin; some are not licensed anywhere.
Other routes include investigational medicines in clinical trials, the Early Access to Medicines Scheme (EAMS) and medicines prepared in a pharmacy under the pharmacist's own exemption. These follow their own rules and are not covered in detail here.
Note that off-label use is different. An off-label medicine is fully licensed in the UK but is used outside the terms of its licence, for example at a different dose or in a different age group.
The legal basis: Regulation 167
The Human Medicines Regulations 2012 generally ban the sale or supply of a medicine without a marketing authorisation. Regulation 167 creates the exemption for "special medicinal products". In summary, supply is lawful only when:
- it responds to an unsolicited order (the prescriber asks for it; the supplier does not promote it);
- a doctor, dentist, or independent or supplementary prescriber specifies the product, for a patient under their direct responsibility, to meet that patient's special needs;
- no advertisement for the product is published by anyone;
- manufacture or assembly is supervised and written records are kept;
- the product is made or imported by the holder of an MS licence or, for imports from an approved country, by a wholesale dealer's licence holder.
The MHRA explains how it applies the regulation in MHRA Guidance Note 14, The supply of unlicensed medicinal products ("specials"), and on its GOV.UK pages on supplying specials and on notifying an intended import.
Special clinical needs and the prescriber's role
The "special need" must be clinical and relate to the individual patient. MHRA guidance is clear that it does not include reasons of cost, convenience or operational needs. A lower-priced imported pack, or one that is simply easier to order, does not qualify.
Whether a special need exists is a decision for the prescriber responsible for the patient's care. The General Medical Council's prescribing guidance adds that the prescriber must be satisfied there is enough evidence or experience of the medicine's safety and efficacy, must take responsibility for prescribing it, and should record the reasons when not following common practice. Pharmacists share responsibility for checking the quality of what they buy and supply.
The order of preference
Guidance Note 14 sets out an order of preference. An unlicensed product should be used only when nothing higher up the list will meet the patient's need.
| Order | Option | Comment |
|---|---|---|
| 1 | UK-licensed product used within its licence | Always the first choice if it meets the clinical need |
| 2 | UK-licensed product used off-label | Preferred over an unlicensed product, though it adds to the prescriber's responsibility |
| 3 | Imported product licensed in its country of origin | Unlicensed in the UK, but assessed by another regulator |
| 4 | Special manufactured in the UK (a completely unlicensed product) | Made under an MS licence; the product itself is not assessed |
| 5 | Product unlicensed in its country of origin | The least acceptable option |
Who can supply unlicensed medicines
Only licensed businesses can make or bring in specials. The licence depends on where the product comes from.
| Activity | Licence needed |
|---|---|
| Manufacturing a special in the UK | Manufacturer's "specials" licence (MS) |
| Importing into Great Britain from an approved country for import (currently the EEA countries) | Wholesale dealer's licence for human medicines, WDA(H) |
| Importing into Great Britain from any other country | Manufacturer's "specials" licence |
| Importing into Northern Ireland from outside the EEA | Manufacturer's "specials" licence |
| Onward wholesale supply by someone who did not make or import it | Wholesale dealer's licence |
Importing: the MHRA notification
Every import of an unlicensed medicine must be notified to the MHRA before it happens. The importer emails a completed notification form, with evidence of compliance with good manufacturing and distribution practice, evidence of special clinical need and, where relevant, evidence of compliance with the rules on transmissible spongiform encephalopathies (TSE). Each product line is a separate notification with its own reference.
Guidance Note 14 asks for notification at least 28 days before the intended import. After acknowledging the notification, the MHRA assesses it and issues one of three letters: no objection (with any conditions), a request for further information, or an objection. The MHRA's notification guidance states that the medicine "must not be imported if an objection to the importation is issued by the MHRA within 28 days" of acknowledgement, and that the importer may not import while further information is outstanding. The MHRA may shorten or waive the 28-day period, and for life-threatening clinical emergencies it may be able to assess a notification within two working days.
Two points are often misunderstood. First, a no-objection letter is not an approval of the medicine; quality and suitability remain the responsibility of the purchaser and prescriber. Second, the MHRA charges fees for vetting imported unlicensed medicines, billed annually and retrospectively.
Record-keeping, safety reporting and labelling
Records. Under Regulation 170, anyone selling or supplying a special must keep records for at least five years, showing the source and date it was obtained, the person supplied and the date, the quantity, the batch number and details of any suspected adverse reaction. Records must be shown to the MHRA on request.
Pharmacovigilance. Regulation 170 also requires suspected serious adverse reactions to be reported to the MHRA. Guidance Note 14 asks licence holders to report within 15 calendar days, and prescribers and pharmacists to use the Yellow Card scheme, stating that the product is unlicensed and who made it.
Labelling. The pack should make clear that the product is unlicensed. UK-made specials should follow the British Pharmacopoeia's labelling guidance for unlicensed medicines. Imported packs often carry foreign-language labels; NHS guidance encourages English over-labelling and translated leaflets where possible.
Northern Ireland after the Windsor Framework
The Windsor Framework arrangements for medicines began on 1 January 2025, bringing in UK-wide licensing and "UK Only" packs for licensed medicines. For unlicensed medicines, MHRA guidance says that importing into Northern Ireland from outside the EEA needs an MS licence, and that unlicensed medicines may move between Northern Ireland and Great Britain without extra MHRA notifications. The supplier must still confirm a special clinical need in the receiving territory.
EAMS in brief
The Early Access to Medicines Scheme gives patients with life-threatening or seriously debilitating conditions access to promising medicines before they have a marketing authorisation, after a positive MHRA scientific opinion. It is a separate route from specials; see our guide to early access programmes.
A worked example
A hospital needs an oral solution for a child who cannot swallow tablets. No UK-licensed liquid exists, and crushing the tablets is not suitable. The pharmacist finds a solution licensed in an EEA country. A WDA(H) holder notifies the MHRA, attaching the foreign marketing authorisation details, a certificate of analysis, GMP evidence and the consultant's statement of clinical need. The MHRA sends a no-objection letter. The importer supplies the pack with an English over-label and a translated leaflet, and records the batch, quantity and recipient. If the only option had been licensed nowhere, a UK special made under an MS licence would usually be considered first.
What overseas manufacturers and exporters should provide
UK importers must send evidence with each notification and assure quality themselves, so a supplier that can provide a complete pack of documents is much easier to work with. Expect to be asked for:
- Licence status in the country of origin: the marketing authorisation holder, number and country, or a Certificate of a Pharmaceutical Product (CoPP);
- GMP evidence for the manufacturing site, such as a current GMP certificate;
- a batch-specific certificate of analysis (CoA), or a QP certificate for EEA batches;
- the product information (summary of product characteristics and patient leaflet), ideally in English or with a reliable translation;
- clear photographs or artwork of labels and packs, storage conditions and shelf life;
- TSE statements where the product uses materials of animal origin.
What buyers should check
Before you order, ask: Does a UK-licensed or off-label option meet the need? Does the importer hold the right licence (WDA(H) or MS) for this source country? Has the MHRA issued a no-objection letter, and with what conditions? Is the CoA for the exact batch supplied? Is the product licensed anywhere, and can the supplier prove it? Will the pack be over-labelled in English, with a leaflet? Is the cold chain or storage documented end to end?
How PharmaTradz can help
PharmaTradz connects licensed UK importers, specials licence holders and hospital pharmacies with manufacturers that can supply the documents above. Our global guide to named-patient import programmes compares other countries, and our explainers on the certificate of analysis and the CoPP cover the key documents. Licensed buyers can request an import or send us an RFQ. For other terms, see our pharma abbreviations A-Z.
Frequently Asked Questions(FAQs)
What is an unlicensed medicine in the UK?
A medicinal product that has no marketing authorisation valid in the UK. It can still be supplied under Regulation 167 of the Human Medicines Regulations 2012, but only on a prescriber's order to meet an individual patient's special clinical needs.
What are specials medicines?
Specials are unlicensed medicines made in the UK by a holder of a manufacturer's "specials" licence, or imported, to meet a named patient's special clinical need. Common examples are oral liquids and unusual strengths not available as licensed products.
Who can import unlicensed medicines into the UK?
Only licensed businesses. Imports into Great Britain from an approved country (currently the EEA) need a wholesale dealer's licence; imports from other countries need a manufacturer's "specials" licence, and every import must be notified to the MHRA first.
How long does the MHRA have to object to an unlicensed import?
MHRA guidance asks for notification at least 28 days before import, and the medicine must not be imported if the MHRA objects within 28 days of acknowledging the notification. The MHRA can shorten this, and can assess life-threatening emergencies within two working days.
Is an off-label medicine the same as an unlicensed medicine?
No. An off-label medicine is licensed in the UK but used outside the terms of its licence. MHRA guidance prefers off-label use of a UK-licensed product to an unlicensed one where it meets the patient's need.
