The Traditional Herbal Medicinal Products Directive (THMPD) was established to provide a regulatory approval process for herbal medicines in the European Union (EU). Since 30 October 2005, herbal medicines in the EU / UK (http://www.mhra.gov.uk
) are now controlled under the EU regulation, 2004/24/EC (Traditional Herbal Medicines Product Directive). Under this regulation, a company needs to demonstrate the safety and efficacy of the herbal medicine through traditional use within the EU for at least 30 years (or 15 years within the EU and 30 years outside the EU). Further, the herbal medicine must be now manufactured under GMP (Good Manufacturing Practice), however, the Traditional Herbal Medicines Product Directive does allow claims to be made on the label of the final product, although restriction do apply.
Herbal Sciences International can evaluate and carry out the necessary analyses and clinical trials of herbal medicine products; research, collate and write the dossier for submission to the MHRA (Medicines and Healthcare Products Regulatory Agency).
For evaluation we have three different stages to help companies decide if the Traditional Herbal Medicinal Products Directive THMPD route is likely to be successful or not and if appropriate, how to obtain regulatory approval.
1. Executive summary - Traditional Herbal Medicinal Products Directive THMPD
Herbal Sciences will conduct a preliminary review of the product and make recommendations on whether to go ahead through the Traditional Herbal Medicinal Products Directive THMPD or whether an alternative regulatory route would be more appropriate. This often includes consultation with the appropriate regulatory body.
2. GAP analysis - Traditional Herbal Medicinal Products Directive THMPD -
If the Traditional Herbal Medicinal Products Directive is a suitable route to approval and marketing authorisation, then the next step is to conduct a complete and thorough GAP analysis of the product to make sure all the necessary studies and analysis have been carried out and to the required standards. Any gaps found in the data will need to be supplied and Herbal Sciences can undertake the laboratory work and associated studies on behalf of the client if necessary.
3. Submission of the dossier -Traditional Herbal Medicinal Products Directive THMPD
Finally, once the GAP analysis has been completed and any missing data has been generated, Herbal Sciences will write the dossier and submit this to the MHRA in the UK or in other EU member states if required.
Please contact Dr Wilkinson in the first instance to discuss your requirements:
Direct Line: +44 (0) 1376 320 354; +44 (0)794169 6409
E mail: info@herbalsciencesinternational.com
with the subject heading: Traditional Herbal Medicinal Products Directive THMPD.
Approval of herbal medicines in the EU without history of use in the EU
We are exploring innovative ways in which we can help our clients get regulatory approval either within the THMP directive or via "specials" with herbal products that do not have 15 years of use in the EU.
This will be of interest to companies that manufacture herbal medicines that have a safe history of use in the country of origin such as China India, Japan, Africa countries, and South America and now want to sell these products in the EU. In certain circumstance it may also be possible to get approval through the Novel Foods Directive although a separate application will be needed to get any health claims approved that are associated with the product.
For more information and in the strictest confidence contact Dr Wilkinson on +44 (0) 794 169 6409.
If you are based in the USA you can call us at local rates on our Washington DC number: 1 (202) 657-6409 (UK times only - approx 5 hours ahead of Washington DC time).
or via e mail: info@herbalsciencesinternational.com 
