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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  16d

CELEX:  02001L0083-20250101

1. Without prejudice to Article 16h(1), Chapter 4 of Title III shall apply by analogy to registrations granted in accordance with Article 16a, provided that:
(a) a Community herbal monograph has been established in accordance with Article 16h(3), or (b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f.
2. For other herbal medicinal products as referred to in Article 16a, each Member State shall, when evaluating an application for traditional-use registration, take due account of registrations granted by another Member State in accordance with this chapter.