MHRA Traditional Herbal Registration (THR)

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.