European Directive on Traditional Herbal Medicinal Products

The European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, was established by the European Parliament and Council on 31 March 2004 to provide a simplified regulatory approval process for traditional herbal medicines in the European Union (EU).

[3] Under this regulation, all herbal medicinal products are required to obtain an authorisation to market within the EU.

Once this time limit has expired, all herbal medicinal products must have prior authorisation before they can be marketed in the EU.

[5] There is concern that some herbal remedies of 30 years ago, which are no longer in widespread use, could still be sold but that valid new herbs which cannot meet the 30-year rule may require to be withdrawn from sale.

The rule could also mean that it may not be possible to license some traditional herbal medicines which were in common use more than 30 years ago, but have since fallen into disuse.