TITLE III

PLACING ON THE MARKET
CHAPTER 2a

Specific provisions applicable to traditional herbal medicinal products
Article 16b
1
The applicant and registration holder shall be established in the Community.
2
In order to obtain traditional-use registration, the applicant shall submit an application to the competent authority of the Member State concerned.
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.