Traditional herbal medicinal product

A herbal medicinal product that fulfils the conditions laid down in Article 16a(1) of Directive 2001/83/EC [DIR 2001/83/EC Art 1(29)], i.e.

(a) it has (an) indication(s) exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;

(b) it is exclusively for administration in accordance with a specified strength and posology;

(c) it is an oral, external and/or inhalation preparation;

(d) the period of traditional use as laid down in Article 16c(1)(c) has elapsed;

(e) the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience [DIR 2001/83/EC Art 16a(1)].

Regarding (d), the product must have been in medicinal use throughout a period of at least 30 years, including at least 15 years within the EU (see DIR 2001/83/EC Art 16c(1)(c)).

See also Herbal medicinal product