S.L. 458.44 ст. 7Refusal of traditional use registration.

(1) Traditional use registration shall be refused if the application does not comply with the conditions set by these regulations or if at least one of the following conditions is fulfilled:

(a) the qualitative and, or quantitative composition is not as declared;

(b) the indications do not comply with the conditions laid down in regulation 3;

(c) the product could be harmful under normal conditions of use;

(d) the data on traditional use are insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience;

(e) the pharmaceutical quality is not satisfactorily demonstrated.

(2) The Authority shall notify the applicant, the Commission and any competent authority that requests it, of any decision they take to refuse traditional use registration and the reasons for the refusal.