Unlicensed Medicines & 'Specials' Explained

A high-level explainer for the UK 'Specials' regime — the route by which a clinician can request a manufactured medicine that does not hold a marketing authorisation.

Educational research-literacy content only. Not medical advice, not dosing guidance, not sourcing advice, and not a protocol for human or animal use. See our responsible information policy.

What a Special is

Under the Specials regime (Regulation 167 of the Human Medicines Regulations 2012), the MHRA permits a holder of a Manufacturer’s “Specials” Licence (MS) to manufacture or import an unlicensed medicinal product to meet the special clinical needs of an individual patient. The product itself does not have a marketing authorisation, and supply is initiated by a prescription from a qualified prescriber (doctor, dentist, supplementary or independent prescriber).

Why Specials exist

Not every clinically useful medicine has a marketing authorisation in the UK. Specials provide a controlled route for clinician-led prescribing when no licensed alternative is suitable — for example, a bespoke formulation, a different strength, or a medicine licensed abroad but not in the UK.

Why this is not a self-purchase route

• A Special must be prescribed by a registered prescriber for an individual patient.
• It must be manufactured or imported by a licence holder.
• It must be supplied through a pharmacy.
• Advertising of Specials to the public is restricted.

A grey-market peptide vial labelled “research use only” is not a Special. It is not within the Specials regime at all.

Why this matters

Some online marketing implies that unapproved peptides are quasi-licit because “unlicensed medicines exist.” The Specials regime is the narrow, clinician-led exception that proves the rule — it is precisely what an unregulated supply chain is not.

See also our explainer on the MHRA Specials glossary term.

Not legal advice

This is a brief educational summary. Any specific question about a Special or about prescribing should be put to a registered clinician or to the MHRA directly.