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.
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 Article 16b
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