# 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

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudr/2001/83/article/16b (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/article-16b
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.