Pharmaceutical Affairs Act Article 99-1

In the case where an application for medicament registration and market approval, change, transfer, or extension of medicament licenses submitted in accordance with this Act is not approved, the applicant may clearly state reasons and apply for re-examination within four months from the date of receiving the decision notice; provided that only one application for re-examination is allowed.The central competent health authority shall alter or revoke the original decision notice if the application for re-examination referred to in the preceding paragraph is justifiable.If the person applying for re-examination does not agree with the decision made under the preceding paragraph, he/she may institute an administrative appeal and further an administrative proceeding in accordance with the applicable laws.