ACE GROUP WORLD – NEED TO KNOW SERIES

Against this backdrop, ACE Group World is proud to introduce the Need to Know Series, a new collection of concise, authoritative publications designed to address the questions clinicians most frequently raise in practice.

These are the topics that sit at the intersection of clinical judgement, governance, ethics and law, the areas
where uncertainty can compromise confidence, consistency and ultimately patient safety.

Abstract

Prescribing is both a privilege and a responsibility. As non‑medical prescribing expands across clinical settings, healthcare professionals must understand the regulatory, legal, and professional distinctions between licensed, off‑label, and unlicensed medicines. This guide integrates both UK and Republic of Ireland (ROI) governance frameworks to support safe, effective, and defensible prescribing across jurisdictions.

Introduction

Aesthetic practice sits at the intersection of medicine, artistry, and patient-centred care. Unlike many areas of healthcare, aesthetic treatments frequently rely on the use of medicines outside the strict boundaries of their Summary of Product Characteristics (SPC). Botulinum toxin is a familiar example: widely used for cosmetic indications that fall outside its licensed Summary of Product Characteristics (SPC).

Both the UK and Ireland permit off‑label and unlicensed use when clinically justified, but the legal basis, regulators, and professional standards differ.

This reality means that aesthetic practitioners routinely operate within a framework where off-label and unlicensed medicine use is normal, accepted, and often essential to meet patient expectations and achieve safe, effective outcomes. However, this also places a heightened professional responsibility on prescribers and those administering treatments. Understanding the legal, regulatory, and ethical distinctions between licensed, off-label, and unlicensed medicines is therefore not optional, it is a core component of safe aesthetic practice.

1. What Do We Mean by “Licensed” and “Unlicensed”?

Licensed medicine:

A licensed medicine has a UK marketing authorisation granted by the MHRA under the Human Medicines Regulations 2012 (HMR 2012). This authorisation confirms that medicine has met the required standards of quality, safety, and efficacy for specific, approved uses. (MHRA 2023).

Legal basis:

• Human Medicines Regulations 2012 (HMR 2012), Part 5, defines requirements for marketing authorisation and the conditions under which medicines may be placed on the market (UK Government, 2012).
• MHRA Guidance: Marketing Authorisations, outlines the standards required for licensing (MHRA, 2023).

The license (marketing authorisation) specifies

• Indications
• Dose and route
• Patient group
• Contraindications
• Side-effects
• Storage and handling

Prescribing within these parameters is considered on-label use.

A licensed medicine has a marketing authorisation granted by the HPRA or the EMA under:

• Medicinal Products (Control of Placing on the Market) Regulations 2007–2014
• EU Regulation (EC) No 726/2004

Ireland follows EU medicines law, unlike the post‑Brexit UK.

• Human Medicines Regulations 2012 (HMR 2012), Part 5, defines requirements for marketing authorisation and the conditions under which medicines may be placed on the market (UK Government, 2012).
• MHRA Guidance: Marketing Authorisations, outlines the standards required for licensing (MHRA, 2023).

The license (marketing authorisation) specifies

• Indications
• Dose and route
• Patient group
• Contraindications
• Side-effects
• Storage and handling

Prescribing within these parameters is considered on-label use.

A licensed medicine has a marketing authorisation granted by the HPRA or the EMA under:

• Medicinal Products (Control of Placing on the Market) Regulations 2007–2014
• EU Regulation (EC) No 726/2004

Ireland follows EU medicines law, unlike the post‑Brexit UK.

Off-label medicine:

A licensed medicine that is used outside the terms of its Summary of Product Characteristics (SPC). This may include using medicine for a different indication, dose, frequency, route, patient group, or anatomical area than those specified in its license.

Botulinum toxin is one of the most widely used medicines in aesthetic practice, yet only a small number of cosmetic indications are included within its marketing authorisation. For example, improvement of glabellar frown lines in adults could be the licensed use, however, in routine aesthetic practice, practitioners commonly administer botulinum toxin to other facial areas such as:

• Horizontal forehead lines
• Crow’s feet (lateral canthal lines)
• Bunny lines on the nose
• Perioral lines
• Masseter hypertrophy for facial slimming
• Platysmal bands in the neck

These uses fall outside the Summary of Product Characteristics (SPC) because they are not part of the medicine’s approved indications. This makes them off-label, even though they are widely accepted, evidence-supported, and considered standard practice within the aesthetics sector.

Off-label use is entirely legitimate when:

• There is a clear clinical rationale
• The practitioner is trained and competent
• The patient is informed that the treatment is outside the license
• The decision is documented
• The treatment aligns with accepted professional practice and safety standards

Ireland does not legislate off‑label use directly. Instead, it is governed by professional standards:

• Medical Council Guide to Professional Conduct and Ethics (2024)
• NMBI Prescribing Standards (2020)
• HSE Medicines Management Programme

            Off‑label use is permitted when:

• It is in the patient’s best interests
• Evidence supports the decision
• No licensed alternative is suitable
• The patient is informed
• The prescriber accepts full responsibility

Unlicensed medicine:

Medicine is unlicensed when it has no UK or Irish marketing authorisation.

Legal and regulatory basis:

• HMR 2012, Regulation 167, permits supply of unlicensed medicines (“specials”) to meet the special clinical needs of an individual patient (UK Government 2012).
• MHRA Guidance on the Supply of Unlicensed Medicines (Specials), sets out prescriber responsibilities and conditions for lawful supply (MHRA,2025).
• GMC Good Practice in Prescribing (2021), Section 68–75, widely used across professions; sets expectations for off-label and unlicensed use.
• NMC Standards for Prescribing Practice (2023), require prescribers to understand the legal status of medicines and the implications of unlicensed use.

Examples include:

• Specials manufactured for individual patients
• Imported medicines
• Using licensed medicine for an unapproved indication, dose, or age group
• Compounded preparations
• Unlicensed use is common in dermatology, paediatrics, palliative care, and other specialties.

Ireland: “Exempt Medicinal Products (EMPs)”

Governed by:

• EU Directive 2001/83/EC Article 5(1)
• HPRA Guide to the Notification System for Exempt Medicinal Products

Pharmacies must notify the HPRA when supplying an EMP.

2. Professional and Legal Responsibilities Regulatory Framework

Prescribers must comply with:

Legislation

• Human Medicines Regulations 2012, legal framework for licensing, supply, and prescribing (UK Government 2012).
• Misuse of Drugs Regulations 2001 relevant where controlled drugs are involved (UK Government 2001).

Regulatory and Professional Standards

• MHRA Guidance on Unlicensed Medicines (Specials), defines when unlicensed medicines may be used (MHRA,2025).
• NMC Standards for Prescribing Practice, sets expectations for safe, evidence-based prescribing (NMC,2023).
• GMC Good Practice in Prescribing, referenced across all prescribing professions (GMC,2021).
• GDC Guidance on Prescribing Medicines (GDC, 2024).
• Royal Pharmaceutical Society (RPS) Competency Framework for All Prescribers adopted by the NMC as the competency standard (RPS,2021).
• BNF and Summary of Product Characteristics (SPC), provide authoritative prescribing information (BNF,2024; EMC, 2024).

Accountability

When prescribing unlicensed medicine, the prescriber assumes greater personal accountability for:

• The decision to prescribe
• Expected benefits
• Potential risks
• Monitoring and follow-up

Regulatory support:

• GMC (2021), para 72: prescribers must be satisfied that an unlicensed medicine better serves the patient’s needs than a licensed alternative.
• NMC (2023): prescribers must justify decisions and document them clearly.
• GDC (2019): The GDC states that prescribers must make “an appropriate assessment of your patient’s condition” before issuing any prescription, and must understand the patient’s health, medication history, and relevant risks. The GDC holds registrants to the same standards of safety, competence, and accountability as in dental practice. This applies equally to private and NHS prescribing.
• MHRA (2025): Specials Guidance: prescribers are responsible for ensuring clinical need.

You must be able to demonstrate that your decision is:

• Evidence-based
• In the patient’s best interests
• In line with accepted clinical practice

Prescribers must comply with:

• Medicinal Products Regulations 2007–2014
• Misuse of Drugs Acts 1977–2016
• HPRA EMP Guidance
• Medical Council / NMBI / PSI prescribing standards

Doctors may prescribe unlicensed medicines freely; nurse and pharmacist prescribers must operate within Collaborative Practice Agreements (CPAs).

3. When Is It Appropriate to Prescribe Unlicensed Medicines?

Unlicensed prescribing may be appropriate when:

• A licensed medicine does not meet the patient’s clinical needs
• No licensed alternative exists
• Evidence supports the unlicensed option as standard practice
• The benefits outweigh the risks

Regulatory support:

• HMR 2012, Regulation 167, unlicensed medicines may be supplied only to meet special clinical          needs (UK Government, 2012).
• GMC (2021), para 70–75, prescribers must consider licensed options first.
• RPS Competency Framework (2021), requires prescribers to choose the safest, most appropriate option.

Prescribers must always consider the hierarchy of risk – Supported by MHRA (2025), GMC (2021), and RPS (2021).

Unlicensed medicines (EMPs) may be used when:

• No authorised product is suitable
• The prescriber takes full responsibility
• The pharmacy notifies HPRA

Governed by Article 5(1) EU Directive 2001/83/EC.

4. Informed Consent and Shared Decision-Making

When prescribing an unlicensed medicine, you must:

• Explain that the medicine is unlicensed or being used off label
• Describe the rationale for its use
• Discuss expected benefits and potential risks
• Provide information in a way the patient can understand
• Document the discussion clearly

Regulatory support:

• GMC (2021), para 71: patients must be informed when medicine is unlicensed.
• NMC (2023): prescribers must support shared decision-making.
• RPS (2021): requires clear communication of risks and benefits.

• Medical Council (2021)
• NMBI (2020)

Patients do not need to sign a separate consent form, but clear documentation is essential.

5. Documentation and Governance

Good documentation protects both the patient and the prescriber. Record:

• Clinical reasoning
• Evidence or guidelines supporting the decision
• Discussion of risks and benefits
• Monitoring plan
• Any advice given to the patient

Regulatory support:

• NMC (2023): requires accurate, contemporaneous documentation.
• GMC (2021), para 75: prescribers must record the reasons for using an unlicensed medicine.
• MHRA (2025): emphasises governance and audit trails.
• HPRA adverse reaction reporting

Ireland does not use the Yellow Card system.

Follow local policies on formularies, specials procurement, medicines governance, and incident reporting.

Who Can Prescribe Unlicensed Medicines?

In the UK, any appropriately qualified and authorised prescriber may prescribe unlicensed medicine, provided they take full clinical and professional responsibility for the decision. This includes both medical and non-medical prescribers.

Doctors: May prescribe unlicensed medicines when clinically appropriate (GMC, 2021).Dentists: May prescribe any medicine listed in the British National Formulary (BNF) on a private prescription. However, they must only prescribe medicines for identified dental needs, not general medical conditions.

Nurse Independent Prescribers (NIPs): May prescribe unlicensed medicines within competence and governance frameworks (NMC, 2023; MHRA, 2022).

Pharmacist Independent Prescribers (PIPs): May prescribe unlicensed medicines within scope (RPS, 2021; MHRA, 2025).

Other Independent Prescribers: Physiotherapists, podiatrists, optometrists, therapeutic radiographers, and paramedics may prescribe unlicensed medicines unless restricted by profession-specific legislation.

Supplementary Prescribers

May prescribe unlicensed medicines if included in the Clinical Management Plan (CMP) (Department of Health, 2003).

In Ireland, prescribing authority is held by doctors, dentists, registered nurse prescribers, registered midwife prescribers, and more recently pharmacists for a limited set of common conditions.

Doctors: hold full prescribing authority,

Dentists: may prescribe medicines relevant to dental practice.

Nurse and midwife prescribers: registered with the NMBI and employed by a health service provider., can prescribe within the boundaries of a Clinical Practice Agreement and their defined scope.

Pharmacist prescribers: have more limited and highly restricted prescribing powers

Other professional groups: Ireland does not grant prescribing rights to the wider range of allied health professionals seen in the UK (e.g., paramedics, physiotherapists, podiatrists).

Across both jurisdictions, community prescribers are not permitted to prescribe unlicensed medicines.

7. Who Cannot Prescribe Unlicensed Medicines?

 In the UK:

• Community practitioners in the (V100/V150), their formulary is restricted and does not include unlicensed medicines.
• Allied Health Professionals Independent Prescribers, however, if that same clinician is also annotated as a Supplementary Prescriber, they may prescribe unlicensed medicine only when acting under a valid Clinical Management Plan (CMP).
• Non-prescribing nurses or HCPs, they may administer but not prescribe.
• Anyone outside a regulated prescriber role.

In Ireland

• Pharmacists may dispense an EMP only on foot of a valid prescription from one of the authorised prescribers. They cannot independently prescribe or initiate unlicensed medicine.
• Other allied health professionals, Ireland does not have extended prescribing rights for these groups, and they have no authority to prescribe unlicensed medicines.
• Practitioners outside the Irish register. A prescription for an unlicensed medicine cannot be dispensed in Ireland if written by a practitioner in another EEA state.

8. Practical Considerations for Prescribers

Before Prescribing

Check BNF, IMF, SPC, NICE, NCEC, CKS, and local formulary; review evidence; consider licensed options first; assess patient factors (BNF, 2024; NICE, 2024).

Function	BNF (UK)	IMF (Ireland)	NICE (England & Wales)	NCEC (Ireland)
What it is	National medicines formulary	National medicines formulary	National evidence‑based guidance body	National clinical guideline programme
Primary purpose	Practical prescribing guidance	Practical prescribing guidance	Clinical guidelines, HTAs, quality standards	National clinical guidelines for Irish health system
Scope	Medicines, dosing, interactions, cautions, prescribing advice	Medicines licensed in Ireland, dosing, interactions, reimbursement	Clinical pathways, diagnostics, public health, cost‑effectiveness	Priority national guidelines (e.g., sepsis, early warning scores, maternity)
Regulatory alignment	MHRA	HPRA	NHS England, MHRA, UK frameworks	Department of Health (Ireland), HSE
Legal status	Authoritative but not statutory	Authoritative but not statutory	Some guidance mandatory, for NHS commissioning	National Clinical Guidelines are mandated for implementation
Geographic relevance	UK	Ireland	England & Wales (NI adopts selectively)	Ireland

When Prescribing

Use the lowest-risk option, ensure informed consent, provide clear instructions, communicate with MDT.

After Prescribing

Monitor treatment effectiveness, review the patient regularly, and document all findings clearly. Report any suspected adverse reactions through the appropriate national system: in the UK via the MHRA Yellow Card Scheme (MHRA, 2024), and in Ireland via the HPRA adverse reaction reporting system, as Ireland does not use the Yellow Card scheme.

Regulatory support:

• HMR 2012, Part 11: establishes the Yellow Card pharmacovigilance system.
• NMC (2023): requires ongoing monitoring and review.
• GMC (2021): prescribers must ensure appropriate follow-up.
• HPRA (2026), Health Products Regulatory Authority.
• NMBI (2018) Practice Standards and Guidelines for Nurses and Midwives with Prescriptive Authority
• IMC/PSI (2025) Safe Prescribing and Dispensing of Controlled Drugs (Joint IMC–PSI Guidance)

References

1. British National Formulary (2024) British National Formulary. London: BMJ Group & Pharmaceutical Press.
2. Dental Council of Ireland 2025, Code of Practice: Professional Behaviour and Clinical Standards, Dental Council of Ireland, Dublin. Available at: https://www.dentalcouncil.ie (Accessed: 27 March 2026).
3. Department of Health (2003) Supplementary Prescribing: A Guide for Implementation. London: DH.
4. Electronic Medicines Compendium (2024) Electronic Medicines Compendium (emc). Available at: https://www.medicines.org.uk/emc (Accessed: 22 February 2026).
5. General Medical Council (2021) Good practice in prescribing and managing medicines and devices. London: GMC. Available at: (gmc-uk.org in Bing) (Accessed: 22 February 2026).
6. General Dental Council (2013) Standards for the dental team. Available at: https://www.gdc-uk.org/standards-guidance/standards-and-guidance/standards-for-the-dental-team (Accessed: 22 February 2026).
7. Health Products Regulatory Authority (HPRA) 2026, Health Products Regulatory Authority, Dublin. Available at: https://www.hpra.ie (Accessed: 27 March 2026).
8. Irish Medicines Formulary (IMF), Meridian Ireland, Dublin. Available at: https://www.imf.ie (Accessed: 27 March 2026).
9. Medical Council of Ireland 2026, Medical Council of Ireland, Dublin. Available at: https://www.medicalcouncil.ie (Accessed: 27 March 2026).
10. Medicines and Healthcare products Regulatory Agency (2025) Supply of unlicensed medicinal products (“specials”). London: MHRA.
11. Medicines and Healthcare products Regulatory Agency (2023) Marketing authorisations and licensing guidance. London: MHRA.
12. Medicines and Healthcare products Regulatory Agency (2024) Yellow Card Scheme. Available at: (yellowcard.mhra.gov.uk in Bing) (Accessed: 22 February 2026).
13. National Clinical Effectiveness Committee, Government of Ireland, Dublin Available at: https://www.gove.ie (Accessed: 27 March 2026).
14. National Institute for Health and Care Excellence (2024) Clinical Knowledge Summaries. London: NICE.
15. Nursing and Midwifery Board of Ireland (NMBI) 2026, Nursing and Midwifery Board of Ireland, Dublin. Available at: https://www.nmbi.ie (Accessed: 27 March 2026).
16. Nursing and Midwifery Council (2023) Standards for prescribing practice. London: NMC.
17. Royal Pharmaceutical Society (2021) A competency framework for all prescribers. London: Royal Pharmaceutical Society.
18. UK Government (2001) Misuse of Drugs Regulations 2001. London: The Stationery Office.
19. UK Government (2012) Human Medicines Regulations 2012. London: The Stationery Office.

CPD 2 Points