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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 article 16b CELEX: 02001L0083-20250101 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. |