Article 16e
1. Traditional-use registration shall be refused if the application does not comply with Articles 16a, 16b or 16c 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 Article 16a; (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 competent authorities of the Member States 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.