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HerbMark® standard for quality assurance

IGFS statement on the challenges ensuring herb and spice authenticity

HerbMark ® gathers momentum assuring quality supplies of medicinal herbs to UK practitioners: Seven suppliers of medicinal herbs to UK practitioners have been awarded the British Herbal Medicine Association’s (BHMA) newly launched HerbMark ®.

Developed by the BHMA under its Herbal Practitioner Suppliers Scheme (HPSS), the quality standard is only awarded to companies that are members of the scheme, following the successful completion of an in-depth audit process to help ensure that herbs administered by UK practitioners (physiotherapists, herbalists and medical herbalists) are manufactured to pharmaceutical standards, ensuring consistently high quality and effectiveness for their patients.

“The objective of the HerbMark ® is to provide assurance to herbal practitioners that accredited medicinal herb manufacturers and distributors are working to best practice, providing them with high quality and safe products for use by their patients.” Dr Chris Etheridge, BHMA Chair.
Since its launch in 2021, seven companies have successfully completed the rigorous audit process and achieved accreditation, these include:

  • Organic Herb Trading (15 Jan 2021)
  • Phoenix (27 Jul 2021)
  • Su Wen Herbs (27 Jul 2021)
  • Herbprime Co. Ltd (13 Sep 2021)
  • Panacea Healthcare (17 Sep 2021)
  • Balance Healthcare (17 Sep 2021)
  • Herbal Apothecary (12 Oct 2021)

“The HerbMark standard was developed using a combination of 40 years GMP (good manufacturing practice) and Food Safety Standards experience supplemented by site visits to medicinal herb manufacturing companies to gain an understanding of their processes,” says Martin Dooley, BHMA Board Member and Qualified Person (QP).see notes to editors “The result is an easy to follow and useful assessment tool to enable organisations to carry out a gap analysis which will then drive a continuous improvement program establishing best practice. Organisations will be audited against this standard on a regular basis, typically every two years.”

Key areas of audit include: Quality Management Systems, Personnel, Premises & Equipment, Production, Documentation, Quality, Out-Sourced Activities, Complaints and Recalls, and Self-Inspection.
At present, statutory regulation of herbal medicinal products in the UK is via the Traditional Herbal Medicinal Products Directive (THMPD) which allows products to be registered under the Traditional Herbal Registration (THR) scheme. Regulated by the UK government’s Medicines and Healthcare products Regulatory Agency (MHRA), the THR scheme assures the quality and safety of a limited number of herbs available to the consumers for purchase over-the-counter. Consumers can identify these products by buying herbal medicines that display the THR logo on pack. Until now, practitioner supply of medicinal herbs has been unregulated, an issue that responsible practitioners have raised concern about. The BHMA’s HerbMark is separate to and not an alternative to the MHRA’s THR Scheme. Regulated by the BHMA/HPSS, the HerbMark is a voluntary scheme that will increase confidence and provide assurance to both practitioners and consumers that they are receiving high quality, safe products.

“We are delighted to have these seven practitioner supplier companies committed to the HerbMark scheme. We’d encourage herbal medicine practitioners to support these companies that have taken significant steps to ensure quality and safety of the herbs they supply, as well as canvass all UK suppliers of medicinal herbs to consider joining the scheme,” Dr Etheridge concludes.

For more information about the HerbMark scheme, visit www.bhma.info/hpss or email secretary@bhma.info

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