KR Südkorea
  • 11 - Medizintechnik
  • 71 - Chemische Verfahrenstechnik


Proposed amendment to the "Regulation on Quasi-drug Approval, Notification and Review" (46 page(s), in Korean)

All mosquito and tick repellents and other related insect repellents shall be subject to a safety and efficacy review, including the ones previously exempted*, thus increasing the number of products subject to the safety and efficacy review and required documents for registration, to better align the country's regulation with the international standards. *Products have the same type of active ingredients, specifications, ingredient quantity (level of concentration for liquid products), formulation, indications and usage, dosage and administration as the products that have already been approved and registered.