S.L. 458.44 Art. 8List of herbal substances.

(1) If an application for traditional use registration relates to a herbal substance, preparation or a combination thereof contained in the list established in accordance with the procedure referred to in Article 121(2) of the Directive, the data specified in regulation 5(1)(b), (c) and (d) need not be provided. Regulation 7(1)(c) and (d) shall not apply.

(2) If a herbal substance, preparation or a combination thereof ceases to be included in the list referred to in subregulation (1), registrations pursuant to that subregulation for herbal medicinal products containing such substance shall be revoked unless the particulars and documents referred to in regulation 5(1) are submitted within three months.