Archive for February, 2011

Legal and political herbal news

Monday, February 28th, 2011

I decided to put this up since so many people have asked me about what’s going on with the combined European legislation, statutory regulation and codex political changes. Of these, codex is the one I know least about, but I think I can give you an accurate picture of the other two.

From April this year (2011), the Traditional Medicines Directive (TMD) comes into force. This is derived from European regulation designed to harmonise Over the Counter (OTC) sales of herbal products. It will mean that any product for OTC sale must have a TMD product license. These licenses are not as difficult to acquire as drugs licenses, but still expensive enough to make this market impossible for small producers. Requirements include providing evidence of traditional use in Europe, GMP (Good Manufactury Practice), and quality control/safety/labelling requirements. The costs per license (per product) is apparently in the region of £30,000 – obviously making this a market for the bigger players. Interestingly, of the 70 products so far to acquire licenses, about a third are through pharmaceutical companies.