Fig. 1

OOS product provision flow. The MAH establishes an evaluation system for OOS products, conducts a risk assessment for each OOS product, and provides the assessment result to the physician. If the OOS product does not meet safety-related specifications, such as sterility testing, it is not provided. The physician considers the possibility of remanufacturing or alternative treatment based on the condition of the patient, and if it is determined that it is medically necessary and the patient wishes to receive the OOS product, the physician requests the MAH to provide the OOS product based on the individual risk assessment provided by the MAH