Menopausal herb wins EU herbal registration

Related tags Herbal medicinal products European union

UK start-up, Bio-Health, has won its second herbal products registration in a year for a sage product that reduces excessive sweating in post-menopausal women.

The product, Salvian, won registration under the Traditional Herbal Medicinal Products Directive (THMPD) and becomes the first sage product to do so in the UK.

Bio-Health had a valerian product registered under THMPD in July last year and the company has made a point of praising the controversial rule.

Bio-Health marketing director, June Crisp, told the company had benefitted from THMPD registration for the valerian product as it validated its claims in the eyes of consumers, and expected a similar result with its latest registration.

She said the latest registration was at a slightly lower level than for the company’s previous version of Salvian, but the product had met stability, safety and efficacy requirements.

Worth the cost

Bio-Health achieved this principally with history-of-use data.

“It has cost a lot – about €60,000 – but we feel it is worth it,” she said. “We think this system is a good system and hope other companies will get their products registered soon,”​ she said. “It will ensure the public has high-quality herbal medicines. If a small company like we can do it anyone can do it.”

All herbal products making medicinal claims must register under the rule by 2011.

Crisp said the company had one other registration waiting for St John’s wort and had other products in preparation.

She noted that some major herbal product suppliers had not yet begun the process of registering their products and wondered what they were waiting for with the deadline fast approaching.

In addition to the claims potential of a product registration, the THMPD dictates that all herbal products not classified as food supplements (like many 'spice rack' herbs such as garlic and sage) or those considered medicines, must gain THMPD registration by April 2011 to legally remain on market.

Germany and the UK have been the most active of the European Union's 27 member states to date.

Bio-Health employs 20 staff and has annual revenue of about €1.2m.

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