Herbal medical products, regristration

Herbal medicinal products are generally evaluated in the same marketing authorisation procedures as chemically defined medicinal products. The most comprehensive type of application is the "full application". Here, the applicant must submit complete preclinical and clinical reports on studies with the specific preparation in order to demonstrate efficacy and safety in the indication area applied for.

Of far greater practical importance, however, is the application with reference to "well-established use". In this case, the applicant does not have to submit his own preclinical and clinical data if he can prove that the active substances of the drug have been in general medical use for at least ten years. The scientific documentation then replaces own studies.

If the evidence is positive, both the full application and the well-established-use application lead to a marketing authorization for the drug. This is to be distinguished from the registration of "traditionalherbal medicinal products"(traditional use).

1. Knöss W et al. (2014) Legal framework. Pharmakon focus issue: complementary therapies. Pharmakon 2: 143-150.