Quasi‑drugs (HS code 3808.94-0000), Quasi-drugs (HS code 9619.99-1090); (HS: 3808, 9619)
Proposed amendments to the "Regulation on Quasi-drug Approval, Notification and Review" (16 page(s), in Korean)
The "Regulation on Quasi-drug Approval, Notification and Review" is being amended by the Ministry of Food and Drug Safety (MFDS) as follows:
A. For external disinfectants containing benzalconium chloride, spraying is being excluded from the instructions for use.
B. External disinfectants that use direct containers in the form of packets or stopper-mounted pouches are required to be indicated in packaging units that exceed 200 mL.
C. Products used for hygienic treatment of postpartum haemorrhage or lochia (postpartum vaginal discharge) have been additionally designated as quasi-drugs (enforcement date: 1 Oct. 2021); accordingly, the scope of safety and effectiveness review data that need to be submitted for these products is to be defined.