Unlicensed medication, explained clearly.
Some treatments supplied through Root & Radiance may include medicines or specially prepared formulations that are unlicensed, or licensed medicines used outside the exact terms of their licence. This page explains what that means before you continue with an online assessment.
Licensed medicine
A licensed medicine has a marketing authorisation for specific uses, doses, routes, and patient groups. The licence is based on evidence reviewed for quality, safety, and efficacy for those approved uses.
Off-label use
Off-label use means a licensed medicine is prescribed outside the exact terms of its licence. This may involve a different indication, dose, route, combination, formulation, or patient group.
Unlicensed medicine
An unlicensed medicine does not have a UK marketing authorisation for that specific medicine, formulation, or use. This can include a specially prepared formulation made to meet an individual patient need.
A careful assessment-first pathway.
Your answers about medical history, current medicines, allergies, pregnancy status, and treatment goals are important for suitability review.
Treatment is supplied only if it is considered appropriate based on the information provided and the prescriber’s clinical judgement.
Where treatment is approved, you should read the directions and any patient information carefully before starting.
If anything is unclear, if symptoms feel severe, or if you experience a concerning reaction, seek appropriate medical advice.
Personalised care
- A licensed option may not meet a patient’s needs.
- A prescriber may judge an off-label route to be more appropriate.
- A specially prepared formulation may be used where suitable.
Risks and information
- All medicines can cause side effects.
- Information leaflets may not always match off-label use exactly.
- Unlicensed or specially prepared medicines may have different supporting information from licensed products.
Complete forms carefully
- Tell us about all medicines and medical conditions.
- Disclose pregnancy, breastfeeding, or trying to conceive where relevant.
- Do not start treatment if the instructions or suitability advice are unclear.
Read the MHRA guidance.
The UK Medicines and Healthcare products Regulatory Agency explains prescriber responsibilities for off-label and unlicensed medicines, including patient information, monitoring, and clinical responsibility. You can read the official GOV.UK guidance here: Off-label or unlicensed use of medicines: prescribers’ responsibilities.
Ask if you are unsure.
This page is general information and does not replace your online assessment or advice from a clinician. If you have questions about a proposed treatment, contact support before using it.