corner detail of a pharmacy front with potted plants and neutral signage, daylight workforce news

Named-Patient and Specials Supply: What Community Pharmacists Need to Know

How unlicensed and specials medicines are supplied on the NHS, the MHRA Specials licence regime, and what to check before dispensing.

By PharmSee Editorial Team · ·

Most prescriptions that cross a community pharmacy counter are for licensed medicines — products with a UK marketing authorisation, a Summary of Product Characteristics, and a patient information leaflet. But a significant minority are not. Named-patient supply and specials prescribing are established features of NHS pharmaceutical care, and every community pharmacist will encounter them.

What is a "special"?

A special — sometimes called a "specials" medicine or an unlicensed medicine — is a medicinal product manufactured or imported specifically to meet the needs of an individual patient when no suitable licensed alternative is available. Under the Human Medicines Regulations 2012 (Regulation 167), specials can only be manufactured by holders of a Manufacturer's Specials Licence (MS licence) granted by the MHRA.

Common examples include:

  • Sugar-free or dye-free liquid formulations for patients who cannot tolerate standard excipients
  • Specific-strength capsules or tablets when the commercially available strengths do not match the prescribed dose
  • Preservative-free preparations for patients with known sensitivity
  • Paediatric formulations where no age-appropriate licensed product exists
  • Discontinued products where the licensed version has been withdrawn from the UK market but the clinical need persists

The regulatory framework

The supply of specials in the UK is governed by a hierarchy of preference established in NHS England guidance and reflected in MHRA enforcement practice:

PriorityOptionWhen to use
1Licensed medicine at the correct dose and formulationAlways the first choice
2Licensed medicine used off-label (different dose, route, or indication)When no licensed alternative at the right dose exists, but clinical evidence supports the off-label use
3Unlicensed medicine from a specials manufacturerWhen no licensed product (on- or off-label) meets the patient's needs
4Imported unlicensed medicineWhen no UK-manufactured special is available; requires an MHRA import notification

This hierarchy matters because prescribers bear additional clinical responsibility when moving down the list. A pharmacist receiving a prescription for a special should satisfy themselves that the prescriber has considered licensed alternatives first.

How specials prescriptions appear

In community pharmacy, specials are prescribed on standard FP10 forms (or their electronic equivalents via EPS). The prescription will typically specify:

  • The drug name, strength, and formulation
  • "Special" or "unlicensed" — though this annotation is not always present
  • The prescriber's signature, indicating acceptance of clinical responsibility for an unlicensed product

There is no separate prescription form for specials. The prescriber's act of writing the prescription is their acknowledgement that a licensed alternative is not suitable.

What community pharmacists must check

Before dispensing a special, pharmacists should verify:

  1. Is this genuinely a special? Check whether a licensed product at the prescribed strength and formulation exists. The BNF, the electronic Drug Tariff, and manufacturer catalogues are the primary references. If a licensed alternative exists, contact the prescriber before ordering the special.
  1. Is the supplier MHRA-licensed? Specials must come from a holder of a Manufacturer's Specials Licence. The MHRA publishes a register of licensed specials manufacturers. Ordering from an unlicensed source is a criminal offence under the Human Medicines Regulations 2012.
  1. Is the product labelled correctly? Specials must carry a label stating the product name, strength, quantity, batch number, expiry date, storage conditions, and the name and address of the manufacturer. The label must also state "Unlicensed medicine" — though compliance with this requirement varies in practice.
  1. Is the price reasonable? Specials are reimbursed through the Drug Tariff Part VIIIB (specials) pricing arrangements. Some specials are listed in Part VIIIB with a set reimbursement price; others are not, and the pharmacist may need to endorse the prescription with the actual cost. NHS England has flagged specials pricing as an area of ongoing scrutiny — pharmacists should be aware of the reimbursement rules and document procurement costs.
  1. Does the patient understand? Patients receiving a special for the first time should be informed that the product is unlicensed, that this is a normal and established part of NHS prescribing, and that the prescriber has accepted clinical responsibility for its use.

Specials manufacturers and the supply chain

The UK has approximately 40 MHRA-licensed specials manufacturers, ranging from large-scale operations (such as Martindale Pharma and Rosemont Pharmaceuticals) to smaller regional compounding units. Some NHS hospital pharmacy departments also hold specials licences for internal supply.

Lead times vary. Common formulations may be available within 24–48 hours from stock-holding manufacturers. Less common requests — particularly those requiring sourcing of raw materials or stability testing — may take one to two weeks. Pharmacists should communicate realistic timelines to patients and prescribers.

Named-patient import

When no UK-manufactured special is available, medicines can be imported from licensed manufacturers abroad under the MHRA's named-patient import scheme. This requires:

  • A valid UK prescription
  • Notification to the MHRA (via the importing wholesaler, who must hold an appropriate licence)
  • Confirmation that no suitable UK-licensed or UK-manufactured alternative exists

In practice, most named-patient imports are handled by specialist importing wholesalers rather than individual community pharmacies. The pharmacist's role is to ensure that the import route is legitimate and that the product arrives with appropriate documentation.

Financial considerations

Specials can be expensive. A sugar-free liquid formulation of a common drug may cost ten times more than the licensed tablet. The Drug Tariff Part VIIIB sets reimbursement prices for commonly prescribed specials, but many remain unlisted, leading to potential shortfalls between procurement cost and reimbursement.

Pharmacists should:

  • Check Part VIIIB before ordering to understand the reimbursement position
  • Endorse the prescription with the supplier's invoice price if the special is not in Part VIIIB
  • Be aware that NHS England's specials pricing audits may query high-cost specials

Further resources


Sources: Human Medicines Regulations 2012, Regulation 167 (legislation.gov.uk); MHRA Guidance Note 14: Manufacture of Specials (gov.uk); NHS Drug Tariff Part VIIIB (nhsbsa.nhs.uk); PharmSee vacancy data as of 14 April 2026.

Sources

  1. Human Medicines Regulations 2012, Reg 167
  2. MHRA Guidance Note 14: Specials
  3. NHS Drug Tariff

Information only — not medical advice

This article is general information about medicines and health conditions in the UK. It is not personalised medical advice and must not be used to diagnose, treat, or manage any condition. Always speak to a GPhC-registered pharmacist, your GP, NHS 111, or another qualified healthcare professional before starting, stopping, or changing any medicine — particularly if you are pregnant, breastfeeding, have kidney, liver or heart disease, or take other medicines. In an emergency call 999.

Sources are cited above for transparency; inclusion of a source does not imply endorsement of this site by the NHS, NICE, UKTIS, or the MHRA. See our Terms & Disclaimer. PharmSee accepts no liability for any loss or harm arising from reliance on this content.