V5 Ultimate
Compliance

MHRA Traditional Herbal Registration (THR)

TL;DR

The Traditional Herbal Registration (THR) scheme, run by the MHRA under the Human Medicines Regulations 2012 implementing the Traditional Herbal Medicinal Products Directive (THMPD 2004/24/EC, retained post-Brexit), is the UK route to market a herbal product with a traditional...

The Traditional Herbal Registration (THR) scheme, run by the MHRA under the Human Medicines Regulations 2012 implementing the Traditional Herbal Medicinal Products Directive (THMPD 2004/24/EC, retained post-Brexit), is the UK route to market a herbal product with a traditional-use indication — without proving efficacy by clinical trial. Requires 30 years of traditional use (15 years in the EU/UK), GMP-licensed manufacture, and a THR number on pack. Many botanicals marketed in the US as supplements need a THR to make any indication on a UK label.

Regulatory anchors
  • Human Medicines Regulations 2012
  • THMPD 2004/24/EC
How V5 handles it
QMS — quality engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Score your compliance gap — then download the validation pack.
A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
Related terms
UK Food Supplements (England) Regulations 2003UK FIR (Regulation 1169/2011 retained) — supplement labelling
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