TITLE IIIPLACING ON THE MARKET
F1CHAPTER 2aSpecific provisions applicable to traditional herbal medicinal products
Article 16a
1
A simplified registration procedure (hereinafter ‘traditional-use registration’) is hereby established for herbal medicinal products which fulfil all of the following criteria:
a
they have indications 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
they are exclusively for administration in accordance with a specified strength and posology;
c
they are 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.
2
Notwithstanding Article 1(30), the presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for registration in accordance with paragraph 1, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).
3
However, in cases where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for authorisation in accordance with Article 6 or registration pursuant to Article 14, the provisions of this chapter shall not apply.
Inserted by Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.