Directive 2001/83/EC of the European Parliament and of the CouncilShow full title

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

[F1Article 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.]