S.L. 458.44 Art. 6Application of regulation22ofthe Medicines Regulations.

(1) Without prejudice to the setting up of the Committee, regulation 22 of the Medicines Regulations shall apply by analogy to registrations granted in accordance with regulation 3, provided that:

(a) a Community herbal monograph has been established by the Committee, or

(b) the herbal medicinal product consists of herbal substances, preparations or combinations thereof contained in the list referred to in Article 16f of the Directive.

(2) For other herbal medicinal products as referred to in regulation 3, the Authority shall, when evaluating an application for traditional use registration, take due account of registrations granted by another Member State in accordance with chapter 2a of the Directive.