(1) Reasons for Proposal
The Amendment reorganizes review regulations for items that have been deleted from the “Designation of the Scope of Quasi-Drugs”; increases the scope of repellents for mosquitoes, ticks, etc., that are subject to safety and efficacy reviews; incorporates the results of reassessments of electronic smoking cessation products; and otherwise facilitates the proper operation of marketing approvals, notifications, and reviews, and addresses and improves upon a number of weaknesses that have emerged from the approval and notification system for quasi-drugs.

(2) Major Provisions
A. Modify approval, notification, and review regulations for product groups that have been deleted from the scope of quasi-drugs such as “extermination products, prevention products, and insecticide lures for flies, mosquitoes, etc.” and “humidifier disinfectants” (Article 2, subparagraphs 8, 9, and 10; Article 3, paragraph 4; Article 9, paragraph 5, subparagraph 4; Article 10, paragraph 1; Article 11, paragraphs 5 and 6; Article 13, subparagraph 7; Article 21, paragraph 2, subparagraph 1, item H and subparagraph 2; Article 28, paragraph 1, subparagraph 2, item G; Article 30, paragraph 3, subparagraph 2, item 8, item B; Article 32, paragraph 1, subparagraph 2, item C and paragraph 2; Articles 33 to 49; Article 50, paragraph 1; Article 51, subparagraphs 1, 2, and 3; Article 52, paragraph 3, subparagraph 2; attached Tables 1, 2, and 8; Forms 1, 2, and 3)
1) In accordance with the enactment of the Safety Control of Household Chemicals and Biocides Act, such quasi-drugs as “extermination products, prevention products, and insecticide lures for flies, mosquitoes, etc.,” “humidifier disinfectants,” “public health insecticides,” “public health rodenticides,” and “disinfectants and antiseptics for infectious disease prevention” were excluded from the scope of quasi-drugs.
2) It is necessary to delete definitions of the excluded items and modify relevant provisions accordingly.
3) The Amendment facilitates the proper operation of marketing approval reviews of quasi-drugs by deleting unnecessary provisions and making other relevant modifications.

B. Increase the scope of safety and efficacy reviews of repellents for mosquitoes, ticks, etc., that are used on the human body for public health purposes (Article 21, paragraph 2, subparagraph 7; attached Table 3 III)
1) It is necessary to harmonize the approval and review criteria with other similar products in Korea and abroad.
2) The Amendment applies domestic and international control standards, etc., to materials submitted for product reviews of repellents to account for overseas control standards and similarities between the relevant products and items that have been transferred to the Ministry of Environment (insecticides, etc.).
3) The Amendment reflects local and international trends and societal demands to enhance the competitiveness of the quasi-drug industry and promote international harmonization.

C. Reflect the results of a reassessment of the scope of materials submitted for safety and efficacy reviews of electronic smoking cessation aids (Article 21, paragraph 2, subparagraph 8; attached Table 3 V-1)
1) The Amendment specifies that when applying for new marketing approval (notification) of a manufactured or imported product that is the same as another product that has previously been reassessed based on toxicity-related information, the reassessment items shall be subject to a safety and efficacy review.
2) The Amendment enhances public trust and strengthens safety control of quasi-drugs through high-standard management of the reliability of the safety and efficacy of products that are the same as previously reassessed products.

D. Clarify provisions on the description of the manufacturers of mask constituents (attached Table 2)
1) Current provisions stipulate that the manufacturing method of a quasi-drug shall state the names and addresses of the manufacturers of the components of the main ingredients.
2) For masks, the names and addresses of the constituent manufacturers are stated and managed since their main ingredients are unclear. The Amendment facilitates proper management of goods by clearly incorporating the applicable criteria into the regulations.

E. Modify terms used in the regulations on marketing approvals, notifications, and reviews of quasi-drugs (Article 2, subparagraph 10; Article 21, paragraph 2, subparagraph 1, item G and subparagraph 6; Article 24, paragraph 3, subparagraphs 3 and 4; attached Table 3 VIII)
1) The Amendment reflects matters resulting from the amendment to the “Designation of the Scope of Quasi-Drugs” and ensures the consistency of terms used in the Notice.
2) The Amendment facilities the proper operation of approval reviews by modifying terms used in quasi-drug marketing approvals.