Valerian receives UK boost with THMPD registration

By Shane Starling

- Last updated on GMT

Related tags Herb Mhra

Botanicals manufacturer Bio-Health is proving smaller companies can
cut it in the thrust and tumble of life under the Traditional
Herbal Medicinal Products Directive (THMPD), by having a valerian
product registered in the UK.

The proprietary valerian product, Valdrian, becomes the 15th​ product to be registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is the first by a wholly UK-based company. Bio-Health marketing director June Crisp told her company's registration was proof that smaller companies were not priced out of the THMPD registrations market. Bio-Health spent about €60,000 on the registration that was lodged with the MHRA on January31, 2007. Further registrations were being sought in Greece and Ireland for Valdrian and the company was preparing dossiers for two more of its herbal products that would be submitted to the MHRA, probably early next year. Registration benefits "We are delighted to have received this registration and excited by its potential,"​ she said. "We've always said the THMPD can be beneficial to smaller companies because it validates products and improves consumer confidence. We can now legally make claims about the product, have greater export opportunities and have no further worries about any potential regulatory grey area." ​Valdrian will be permitted to state that it can be used "for temporary relief from symptoms of mild anxiety".​ She urged other smaller botanicals players to move on registering their products as the 2011 deadline was looming. "After 2011, products that have not been registered won't be allowed on-market. There will be internet back-door operators but they will be clamped down on too. But we are a small company with limited resources and we have proven these registrations are economically viable as we have paid for it from our revenue streams and have two more on the starting blocks." ​ Crisp said the Kent-based company aimed to have all its herbal products registered by 2011 "The latest registration is the first granted to a small UK manufacturer, Bio-Health Ltd, illustrating that the scheme can be used by smaller as well as larger companies,"​ MHRA's head of herbal policy, Richard Woodfield, told UK magazine, Natural Products News​. The previous MHRA registration was granted to another UK company, Bioforce, for a St John's wort product called Hyperiforce. MHRA has received applications from 10 companies, rejected none and has about 20 applications in process. 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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