Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (c. 83)

TITLE III U.K. PLACING ON THE MARKET

[F1 CHAPTER 2a U.K. Specific provisions applicable to traditional herbal medicinal products

Article 16b U.K.

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.]

Textual Amendments

F1 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.