Licensing Herbal Medicinal Products under the EU Traditional Herbal Medicinal Products Directive (THMPD)

The European legislation regarding herbal medicines has undergone significant changes over the last few years. As of 2011, herbal medicines will require full licensing throughout the European Union. In any European country after this date it will be illegal to sell or supply any herbal medicine that has not been licensed.

Especially in markets with the most drastic legislative impact, like the UK and Ireland, where herbal medicines were previously mainly unlicensed, competitive advantages exist for manufacturers with established high-quality products: in the registration process itself and also in obtaining a substantial market share. Any herbal products which are not complying with the new regulations will be taken off the shelves.

Our mission is to help those interested in the Traditional Herbal Medicines Directive, or any other way of registering their herbal products by providing professional advice and support to achieve licensing throughout Europe.

Our team of experts assists with registering products as traditional (THMP) or well-established use (WEU) herbal medicines in accordance with the European regulations, specifically in the UK. We have already submitted numerous registration applications on behalf of clients in the UK, Germany and the US.

In order to assist manufacturers with complying with the new regulations we have just published a handbook on the procedural requirements. We have also prepared a number of workshops to be held in the near future in Europe and the US in order to provide interested parties with hands-on advice.

The services we offer range from assessing feasibility all the way to assembling the registration dossiers and associated documentation for THMP, WEU and full market authorization (MA). We take the product through the registration process, and we can also help with setting up a sourcing, contract manufacturing or distribution system or with finding suitable distribution partners.

 

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