Regulation on licensing of traditional herbal medicinal products.

This Regulation sets out the procedures and principles to be applied in licensing procedures in order to ensure the quality, safety and efficacy of traditional herbal medicinal products. The provisions of this Regulation shall apply to herbal medicinal products which are prepared industrially or produced by a method involving an industrial process. This Regulation lays down provisions on the evaluation, grant, refusal, duration and cancellation of licenses; obligations of the licensee; summary of product characteristics; and requirements of packaging. This Regulation has been drafted in line with 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.