S.L. 458.44 Art. 10Herbal monographs.

(1) When Community herbal monographs have been established by the Committee, they shall be taken into account by the Authority when examining an application. Where no such Community herbal monograph has yet been established, other appropriate monographs, publications or data may be referred to.

(2) When new Community herbal monographs are established, the registration holder shall consider whether it is necessary to modify the registration dossier accordingly. The registration holder shall notify any such modification to the Authority.