Traditional Herbal Registration
What it is. Traditional Herbal Registration (THR) is the UK scheme, run by the MHRA, that lets a herbal medicine be sold on the strength of traditional use. The applicant must submit a quality dossier on the herbal ingredients, an expert safety review, a summary of product characteristics, and a draft label and leaflet. They must also show that the product has been used for the stated condition for at least 30 years, with at least 15 of those years in the EU/EEA or, for Great Britain-only products, in a country with comparable pharmacovigilance. A THR is only granted for minor conditions that do not need medical supervision, such as a cold. Products claiming to treat a major condition need a full marketing authorisation instead (GOV.UK/MHRA). Approved products carry a THR number and the THR Certification Mark, and the MHRA publishes a list of all registered products. MHRA [regulates] Traditional Herbal Registration Traditional Herbal Registration [relates] Herbal and Home Remedies for Eczema
What the mark does and does not mean. The THR mark shows that the product meets standards of manufacturing quality, safety and evidence of traditional use. It does not show that the product works. Local NHS prescribing guidance says THR comes “with no requirement for clinical trials or scientific evidence of the products efficacy”, and lists herbal treatments, almond oil and evening primrose among items that should not be routinely prescribed at NHS expense (Lincolnshire PACEF). Many products sold as “natural” are not medicines at all. They are classed as cosmetics or food supplements, so they need no THR, and oils such as Almond Oil and supplements such as Evening Primrose Oil fall outside the scheme. For a toddler, the safety assessment covers only the indication and age range printed on the pack. Traditional Herbal Registration [contradicts] Herbal and Home Remedies for Eczema Evening Primrose Oil [relates] Traditional Herbal Registration
How a parent can check a product. When the MHRA warns about steroid-spiked “herbal” creams, it tells parents to look for a Marketing Authorisation (MA), Product Licence (PL) or THR number, or the THR logo, before using any “natural” medicine on a baby or young child. A cream that claims to treat eczema but has none of these numbers is being sold outside the medicines system. That is the pattern seen in Adulterated Herbal Creams containing undeclared clobetasol (MHRA 2018). Parents can also search the GOV.UK list of THR-registered products. Suspect products can be reported to the MHRA. Traditional Herbal Registration [opposes] Adulterated Herbal Creams MHRA [opposes] Adulterated Herbal Creams
Unlicensed "natural" eczema creams
A “herbal” cream that works dramatically fast and has no MA, PL or THR number may contain an undeclared potent steroid. Stop using it on the child and show it to the GP or pharmacist.
Connections
- Adulterated Herbal Creams — check for THR number to avoid unlicensed creams, source: MHRA 2018
- MHRA — administers the scheme, source: GOV.UK About us
- Herbal and Home Remedies for Eczema — THR certifies traditional use, not efficacy, source: GOV.UK THR guidance; Lincolnshire PACEF
- Evening Primrose Oil — outside THR; not routinely NHS-prescribed, source: Lincolnshire PACEF
- Almond Oil — natural oil sold without THR, source: Lincolnshire PACEF