Explore European Union Legislation by Asking a Legal Question
assisted-checkbox
filter-instruction-1
positive-filters
negative-filters
act-filter tabs-all
parameters-title
query
assisted-checkbox: ✅
result-title
total 1
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use article 16e CELEX: 02001L0083-20250101 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. |