Herbals directive will increase confidence, says MHRA

By Jess Halliday

- Last updated on GMT

Related tags: Healthcare products regulatory, Products regulatory agency, Marketing, European union, Medicine, Mhra

The newly-enacted EU directive will give consumers more confidence
in the safety of traditional herbal medicinal products, according
to the UK's MHRA.

The Medicines and Healthcare products Regulatory Agency, a government body, said that the directive means that responsible companies that follow high standards will no longer be at a commercial disadvantage, now that consumers have some indication of which products are made to acceptable standards.

The registration of products involves supplying evidence on the safety and traditional use of the remedy.

The MHRA believes that the directive, which came into force yesterday, is a "significant improvement in legislation" in the UK - even though products legally marketed in the UK as at April 2004 benefit from a transitional window until April 2011.

Roy Alder, Director of Executive Support at the Medicines and Healthcare products Regulatory Agency (MHRA) said:

"This legislation means that consumers will have assurance as to the quality and safety of manufactured over the counter traditional herbal medicines registered under the new scheme,"​ said director of executive support Roy Alder.

"It will allow for more informed choices as registered products will be accompanied by reliable information about the product and how to use it."

Dr Dick Middleton, chairman of the British Herbal Medicine Association said:

"The BHMA is looking forward to the time when all herbal medicines are approved by the MHRA for quality and safety, thus ensuring that the general public have wide access to safe, effective, high quality herbal medicines."

However not everyone is as confident that the new rules will be a good thing for the industry.

There are some fears that companies will have to shoulder high costs to register their products, including investing in quality control if they do not have a medicines manufacturing licence, and tracing products back to the field.

Some of these costs maybe passed on to consumers through product price increases, but Penny Viner, chairwoman of the Herbal Forum, predicted that there will be some product losses.

"The overriding concern about this directive is the cost,"​ she told NutraIngredients.com last week.

"But to a degree, some of the increased costs are inescapable and it really is about planning ahead."

Related topics: Regulation & Policy, Suppliers, Botanicals

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