definiens: ( as defined below ) . The notification shall be made in the appropriate fonnat prescribed in the said procedures by the fastest available means . The responsibility for submitting any such report to health registration authorities in particular countries shall be stipulated in the said procedures . Upon the request of one Party, the other Party shall promptly investigate a serious adverse event and shall promptly submit follow - up reports upon the receipt of new infonnation . The said procedures are subject to such changes as may be adjudged necessary or as shall be required by applicable law . For the purposes of this provision, shall mean any adverse drug experience occurring at any dose that results in any of the following outcomes : death, a life - threatening adverse drug experience ( Le . placing the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred ), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, or a congenital anomalylbirth defect . Important medical events that may not result in death, be life - threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above