Telephone: +44 (0)1223 750638
As a result of the EU Herbal Directive coming into full force on 1st May 2011, GRS has been extremely busy conducting herbal product assessments. Our Herbal Team has been working virtually 24/7 to turn these around so that companies can act now to ensure their products remain on the market or be re-launched in the very near future. The 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 turn around 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:
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.
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.
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Global House, Painters Lane, Sutton, Ely,
Cambridgeshire, CB6 2NS, UK
Telephone: +44(0)1223 750638