Unlicensed medicines, known as ‘specials’, may lawfully be used in aesthetic practice only to meet an individual patient’s special clinical need when no suitable licensed alternative exists, under Regulation 167 of the Human Medicines Regulations 2012. The prescriber takes on increased personal responsibility for evidence, consent, monitoring and supply verification, and proactive advertising of these products is prohibited.
TL;DR:
- Before prescribing, consider licensed use, supported off label use, and imported products authorized in recognized markets; reserve a UK special for needs none can meet.
- For each case, document rejected alternatives, evidence for safety and efficacy, consent that names the unlicensed status, and a monitoring plan with review points.
- Verify a supplier’s current Manufacturer’s Specials Licence or Wholesale Dealer’s Authorisation, then retain product batch records, invoices, supply paperwork, and required MHRA notification evidence.
- Clinics may answer a specific unsolicited question factually, but must record the exchange and avoid displays or online content that could solicit orders.
- After a suspected reaction, treat the patient first, report through Yellow Card with batch and supplier details, and preserve packaging and supply records.
Table of Contents
- What counts as a ‘special’ and how it differs from off-label prescribing
- Key regulations and MHRA guidance you must know
- Prescriber responsibilities: clinical justification, consent and record keeping
- Sourcing and supplier checks: licences, notifications and red flags
- Promotion and advertising: what is prohibited and how to respond to enquiries
- Safety, adverse-event reporting and suspected counterfeit products
- A practical compliance checklist for clinic use
- Professional duty, caution and practical stewardship
- How we support compliant, verified supply for qualified practitioners
- FAQ
- Sources
What counts as a ‘special’ and how it differs from off-label prescribing
A ‘special’ is an unlicensed medicinal product manufactured or imported to meet a specific patient’s clinical need, rather than a product that holds a UK marketing authorisation. In aesthetic practice this might involve a generically labelled anti-wrinkle treatment, dermal filler or hyaluronic acid filler sourced outside the standard licensed route when no licensed equivalent fits the clinical picture.
This is a different situation from off-label use, where a prescriber uses a licensed product outside the terms of its marketing authorisation but the product itself still carries full regulatory approval and quality assurance. A ‘special’ carries no such UK authorisation at all.
Before reaching for an unlicensed product, prescribers should work through a clear hierarchy:
- Use a licensed product strictly within its marketing authorisation wherever one is suitable.
- Consider a licensed product used off-label when the clinical need justifies it and evidence supports the approach.
- Look at an imported licensed product authorised in another recognised market before turning to a special.
- Use a UK-manufactured special only when none of the above meets the patient’s genuine clinical need.
Key regulations and MHRA guidance you must know
Two provisions of the Human Medicines Regulations 2012 govern this area. Regulation 167 permits supply of an unlicensed medicine only to fulfil the special clinical needs of an individual patient, and only following an unsolicited order from a doctor or other appropriate prescriber. Operational convenience, cost or routine demand do not qualify as a special clinical need.
Regulation 279 prohibits advertising of any medicine without a valid UK marketing authorisation. In practice, this means clinics cannot promote unlicensed products to clinicians or the public, though answering a genuine, unsolicited question about a specific product factually is permitted.
One clear takeaway: MHRA guidance note GN14 sets out exactly what documentary evidence of special clinical need and supplier licensing should look like, and this is the reference document regulators expect practitioners to know.
For aesthetic practice, the most relevant parts of MHRA guidance cover:
- Supply conditions and the unsolicited order requirement under Regulation 167.
- Advertising restrictions and the narrow factual-response exception under Regulation 279.
- Manufacturing and import standards expected of any supplier producing specials.
Prescriber responsibilities: clinical justification, consent and record keeping
Professional regulators are explicit that prescribing an unlicensed medicine shifts personal responsibility onto the prescriber. The GMC’s guidance on prescribing unlicensed medicines states that the prescriber must ensure there is sufficient evidence of safety and efficacy, and must be prepared to justify that decision.
A practical checklist for every case:
- Document the specific special clinical need and explain why no licensed product, including off-label use, was suitable.
- Record the alternatives considered and the reasoning for rejecting each one.
- Obtain and document informed consent that explicitly covers the unlicensed status of the product.
- Set a monitoring plan with defined review points and an escalation route for adverse effects.
- Retain every record in a form that could be produced for an MHRA or employer audit.
Pro Tip: Build a single-page clinical rationale template for specials so that every case produces the same structured record, rather than relying on free-text notes that vary by clinician.
Clinical governance here is not a formality. An audit trail showing clear reasoning, documented consent and active monitoring is the main evidence a prescriber has if a regulator or employer later reviews the decision.
Sourcing and supplier checks: licences, notifications and red flags
Supplier due diligence is where many of the real risks in this area actually sit. A legitimate supplier of unlicensed medicines should hold a Manufacturer’s Specials Licence or Wholesale Dealer’s Authorisation, and should be able to produce MHRA notification records on request.
Checks worth running before any order:
- Confirm the supplier’s licence number and verify it matches current MHRA records.
- Ask for batch documentation and chain-of-supply paperwork for the specific product you intend to order.
- Treat unsolicited marketing of unlicensed products, vague provenance, or reluctance to share licence details as warning signs.
| Supplier check | What to request | Why it matters |
|---|---|---|
| Manufacturing authorisation | Manufacturer’s Specials Licence number | Confirms legal right to produce specials |
| Wholesale authorisation | Wholesale Dealer’s Authorisation (WDA(H)) | Confirms legal right to distribute |
| Batch traceability | Batch numbers and invoices | Supports audit trail and recall response |
| MHRA notification | Evidence of notification where required | Demonstrates regulatory transparency |
Retain every invoice, shipping record, batch number and prescriber letter for each special supplied. Our guide to what to look for in an aesthetics injectable supplier sets out a fuller version of this checklist for clinic use.
Promotion and advertising: what is prohibited and how to respond to enquiries
Regulation 279 draws a firm line between answering a question and running a promotion. Displaying unlicensed vials at a conference stand, or publishing proactive online content about an unlicensed product, has repeatedly attracted MHRA enforcement attention, including an investigation into promotion of unlicensed botulinum toxin medicines at a UK conference.
What is permitted:
- Answering a specific, unsolicited question from a clinician about a named unlicensed product factually.
- Keeping a written record of what was asked and what factual information was given.
- Declining to answer in a way that could be read as inviting further orders or demand.
Anything that looks like solicitation, rather than a direct response to a genuine query, sits on the wrong side of this line.
Safety, adverse-event reporting and suspected counterfeit products
Patient safety comes first if a reaction occurs. The steps to follow, in order:
- Manage the immediate clinical presentation and escalate to emergency care where the reaction is serious.
- Report the event through the Yellow Card scheme, including batch number, supplier details and the full clinical course.
- Preserve the product packaging, remaining stock and all supply documentation as evidence.
- Cooperate fully with any MHRA investigation or border enforcement enquiry that follows.
MHRA’s crackdown on illegal unlicensed botulinum toxin products involved the seizure of more than 4,700 vials after patients were hospitalised, a reminder that illicit supply chains carry real clinical risk, not just regulatory exposure.
A practical compliance checklist for clinic use
Running a short audit against your own clinic reduces exposure considerably. Check that you have:
- A standard clinical rationale template completed for every special prescribed.
- A consent form that specifically names the product as unlicensed.
- A current licence check on file for every supplier used.
- MHRA notification evidence where your supplier’s product requires it.
- A record retention policy covering batch numbers, invoices and prescriber letters.
- A written Yellow Card reporting process that staff know how to follow.
Pro Tip: Run this checklist quarterly rather than once at onboarding; supplier licences and product ranges change more often than clinics expect.
Our guide to the five MHRA-checked documents UK clinics must get from a medicine supplier and our overview of safer prescribing practice for botulinum toxin both support this audit process for qualified practitioners.
Professional duty, caution and practical stewardship
Patient safety has to outweigh convenience every time a special is considered. A licensed product, used correctly, remains the first choice whenever one genuinely fits the clinical need, and reaching for an unlicensed route should always feel like a deliberate, documented exception rather than a routine habit.
Verifying suppliers properly and keeping thorough records is not bureaucratic box-ticking. It is the practical difference between a defensible clinical decision and an exposed one. Make use of the compliance resources and training available to you, and treat them as part of ordinary practice rather than something reserved for after something goes wrong.
— Rizwan
How we support compliant, verified supply for qualified practitioners
We supply dermal fillers, toxins, weight loss medicines, vitamins and consumables to verified healthcare professionals and aesthetic practitioners only, with aligned documentation and extended order cut-off times designed to support clinic delivery planning.
Every account goes through practitioner verification before an order can be placed, and our supplier documentation supports the audit trail checks covered above. You can browse our dermal filler and toxin ranges, alongside weight loss medicines and IM/IV vitamins, to see current stock. If you want to talk through compliant supply for your clinic, get in touch with our team and we will walk you through verification and documentation for qualified practitioners.
This article is general information, not a substitute for advice from a qualified doctor. Consult a qualified healthcare professional about your own circumstances before acting on anything here.
FAQ
What is an unlicensed medicine or ‘special’ in aesthetic practice?
A ‘special’ is a medicine manufactured or imported without a UK marketing authorisation, supplied only to meet an individual patient’s special clinical need under Regulation 167. It differs from off-label use, where the product itself still holds full UK licensing.
Can clinics advertise unlicensed aesthetic products?
No. Regulation 279 of the Human Medicines Regulations 2012 prohibits advertising of any medicine without a UK marketing authorisation, as confirmed by MHRA’s advertising investigation into unlicensed botulinum toxin promotion. A factual answer to a genuine, unsolicited question is permitted, but proactive promotion is not.
Who is responsible if an unlicensed medicine causes harm?
The prescriber carries primary personal responsibility for the safety and efficacy of an unlicensed medicine, according to GMC prescribing guidance. This includes ensuring adequate evidence, documented consent and ongoing monitoring.
What should I check before buying from a supplier of unlicensed products?
Confirm the supplier holds a Manufacturer’s Specials Licence or Wholesale Dealer’s Authorisation, and ask for batch documentation and MHRA notification evidence for the specific product. Unsolicited marketing or vague provenance are red flags worth treating seriously.
What do I do if I suspect a counterfeit or illicit aesthetic product?
Manage any clinical presentation first, then report the event through the Yellow Card scheme with batch numbers, supplier details and the clinical course. Preserve the product and all supply documentation, since MHRA’s enforcement action against illegal botulinum toxin supply shows these cases often lead to wider investigations.
Sources
- Gov
- The supply of unlicensed medicinal products (‘specials’) – MHRA guidance note
- GMC: Prescribing unlicensed medicines