TITLE IIIPLACING ON THE MARKET
F1CHAPTER 2aSpecific provisions applicable to traditional herbal medicinal products
Article 16g
1
Articles 3(1) and (2), 4(4), 6(1), 12, 17(1), 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108, 111(1) and (3), 112, 116 to 118, 122, 123, 125, 126, second subparagraph, and 127 of this Directive as well as Commission Directive 91/356/EEC26 shall apply, by analogy, to traditional-use registration granted under this chapter.
2
In addition to the requirements of Articles 54 to 65, any labelling and user package leaflet shall contain a statement to the effect that:
a
the product is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use; and
b
the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
A Member State may require that the labelling and the user package leaflet shall also state the nature of the tradition in question.
3
In addition to the requirements of Articles 86 to 99, any advertisement for a medicinal product registered under this chapter shall contain the following statement: Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use.
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.