Services: Herbals & Botanicals (Europe)
The EU Herbal Directive came into full force on 1st May 2011 and as from 1st May 2014, herbal companies and retailers who still have unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL) can no longer sell these products to consumers and therefore, these products must be removed from shelves.
GRS has conducted numerous herbal product assessments so that companies can act now to ensure their products are compliant or at some point in the future. The GRS Team has a lot of knowledge and experience in this field. GRS is happy to take on a single product assessment or review a client's entire herbal product portfolio. Prompt turnaround times can be assured.
A GRS product assessment consists of a high level review (including literature and comparator product research) on the product in question (particularly its ingredients) against certain regulations. These regulations can vary according to a client's needs and can include an assessment against the regulations for:
- food and/or food supplement with health claim
- traditional herbal remedy
- medical device
- full product licence
The resulting report will outline where compliance is, and is not, met; what information is needed to reach compliance and some initial recommendation(s) on wording and reformulation of the product (if needed).
If it is deemed that a Traditional Herbal Registration is required, the next stage is to conduct a Preliminary or Feasibility report, the purpose of which is to judge whether there appears to be sufficient 'Traditional Use' evidence for a herbal.
This Preliminary or Feasibility report can help companies make an informed decision as to whether or not they should proceed with a full traditional herbal registration. If 'yes', then the Preliminary or Feasibility report will form part of the full Expert and Safety reports required for submission under the Traditional Herbal Medicines Registration Scheme (THMRS).
If you would like to explore any of the above further or need our help to compile your application, please do not hesitate to contact us with your specific regulatory compliance requirements.