TITLE III

PLACING ON THE MARKET
CHAPTER 2a

Specific provisions applicable to traditional herbal medicinal products
Article 16d
1
Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that:
a
a Community herbal monograph has been established in accordance with Article 16h(3), or
b
the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.
2
For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter.
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.