Herbal and homeopathic remedies are regulated differently from food supplements, and the rules are often misunderstood. This guide explains, in plain English, how the UK system works, what a registration means and what to look for on a label.
It is general information only and not legal or medical advice. For any health concern, speak to your pharmacist or GP.
- Herbal medicines: a product sold for a health condition normally needs a traditional herbal registration (THR).[1]
- Herbal practitioners: a separate exemption covers remedies made for individual patients after a consultation.[1]
- Homeopathic medicines: two registration schemes apply, and they allow different things to be said on the label.[3]
Herbal Medicines and Food Supplements: What Is the Difference?
A herbal medicinal product is one whose active ingredients are herbal substances or herbal preparations only. Vitamins and minerals can be added in certain cases, provided their action is ancillary to that of the herbal ingredients.[2]
A plant ingredient sold as a food supplement is treated as a food, not a medicine. That means it cannot be sold as treating or preventing a disease, and any health claim it makes must be an authorised one. Many plant ingredients have no authorised claim at all.
Traditional Herbal Registration (THR)
A traditional herbal registration is needed before a traditional herbal medicinal product can be marketed in the UK.[1] The main points are:
- Minor conditions only. A THR is granted for minor health conditions that do not need medical supervision, such as a cold. Products claiming to treat major conditions need a full marketing authorisation instead.[1]
- Traditional use. The product must show traditional use for the stated condition for a minimum of 30 years. For UK-wide or Northern Ireland products, at least 15 of those years must relate to use in the EU or EEA.[1]
- Great Britain only. For products sold only in Great Britain, the MHRA may accept the 15 years of evidence from a wider range of countries, provided they have pharmacovigilance equivalent to the UK’s.[1]
- Label. The THR certification mark appears on the label and the patient leaflet of a registered product.[1]
The 15-year provision exists to make sure any safety issues have been properly identified.[2] A registration therefore reflects safety, quality and long traditional use for a stated minor condition.
Herbal Practitioners and the Exemption
Herbal practitioners do not need a licence to supply herbal medicinal products they make on their own premises for patients after a one-to-one consultation.[1] This exemption covers a remedy made for an individual patient. It does not cover products made in advance and sold on a shelf or online, which need a registration.
Homeopathic Medicines: Two Schemes
The UK has two schemes for homeopathic medicinal products.[3]
- Simplified Registration Scheme. The first registered dilution must be at least 1 in 10,000 of the starting material. Products are for oral or external use, make no therapeutic claims and have no stated indications.[3]
- National Rules Scheme. There is no restriction on the first dilution or form. Products may be described as used within the UK homeopathic tradition for the relief or treatment of minor symptoms and conditions that do not need a doctor’s supervision. Applicants submit data on quality, safety and traditional use, and the outer label must state "UK Only".[3]
From 1 January 2025 the MHRA only authorises products through the National Rules on a UK-wide basis.[2] Registration is about quality, safety and the traditional-use description of a product. It is not the same as a licence granted on proof of effect.
What to Check Before You Buy
- Look for the registration. A registered herbal product carries the THR certification mark. The MHRA publishes a list of herbal medicines granted a THR.[4]
- Read the claim. A registered product describes use for a minor condition. A product that promises to cure a serious disease is a warning sign.
- Read the ingredients. Check the plant names, the amounts and any warnings, including who should avoid the product.
- Tell your pharmacist or GP. Herbal products can interact with prescribed medicines, so mention them before you start, especially before surgery or if you are pregnant or breastfeeding.
- Buy from a reputable seller. Be cautious of unregistered products sold online with medical claims.
Clinical Comparison: Herbal Medicine, Homeopathic Medicine and Food Supplement
| Feature / Aspect | Registered Herbal Medicine | Registered Homeopathic Medicine | Food Supplement |
|---|---|---|---|
| Regulated as | A medicine (THR). | A medicine (simplified or National Rules scheme). | A food. |
| What the label may say | Traditional use for a minor condition. | No indications (simplified) or traditional use for minor symptoms (National Rules). | Only authorised health claims, and no disease claims. |
| Look for | THR certification mark. | Registration details, and "UK Only" on National Rules products. | Ingredient amounts and warnings. |
Frequently Asked Questions
Do I need a licence to buy herbal remedies?
No. The rules apply to sellers and makers. As a buyer, check that the product is registered or comes from a practitioner after a consultation.
Can a herbal practitioner make me a remedy without a licence?
Yes, if they make it on their own premises for you after a one-to-one consultation.[1]
What does THR stand for?
Traditional herbal registration. It is issued by the MHRA for traditional herbal medicinal products used for minor conditions.[1]
Are homeopathic remedies registered in the UK?
Yes, under the Simplified Registration Scheme or the National Rules Scheme.[3]
Should I tell my GP about herbal products?
Yes. Always mention herbal and homeopathic products to your GP or pharmacist, particularly if you take prescribed medicines.
Continue the Health Basics Series
- → Post 1: Dental Health: Nutrients for Normal Teeth and Gums
- → Post 2: Post-Meal Bloating: Everyday Gut Health Habits
- → Post 3: Herbal and Homeopathic Remedies in the UK: What the Rules Say (you are here)
References
- [1] GOV.UK. Apply for a traditional herbal registration (THR). gov.uk
- [2] GOV.UK. Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products. gov.uk
- [3] GOV.UK. Register a homeopathic medicine or remedy. gov.uk
- [4] GOV.UK. Herbal medicines granted a traditional herbal registration (THR). gov.uk