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Herbals and Botanicals (Global)

The Directors of Global Regulatory Services (GRS) were advisors to Work Package 7 of GP-TCM, the first EU-funded Coordination Action consortium dedicated to Traditional Chinese Medicine (TCM) research which ended on 31 October 2012.  One of the key deliverables of the Work Package 7 was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies.  The resulting paper can be downloaded here.

GRS’s involvement with this consortium means that the company is particularly well placed to support herbal and botanical companies throughout the world to be compliant with the regulations for their domestic and/or overseas markets.  Regulations are constantly changing and becoming more stringent.  We understand and appreciate that, in many instances, the workload now required to comply with regulations has not been planned or budgeted for.  Any cost which hasn't been included in a company's business plan always feels expensive.  By using our services, however, you will be tapping into our regulatory knowledge and expertise which will save you time and therefore, money.

It is important to ‘classify’ your product as this will have implications on your regulatory and marketing strategies.  Herbal and Botanical Products can be classified as any of the following:

  • Cosmetic
  • Food for Particular Nutritional Use (ParNuts)
  • Food for Special Medical Purposes (FSMPs)
  • Food Supplement (with or without claims)
  • Medical Device
  • Medicinal Product
  • Novel Food
  • Orphan Drug
  • Traditional Herbal Medicine

If you would like to explore this further, please do not hesitate to contact us with your specific regulatory compliance requirements.

In the meantime, if you are interested in maintaining your awareness of changes within the global herbal industry, please visit our blog and consider signing up to the RSS Feed.