Korea | Proposed amendment to the “Regulation on Quasi-drug Approval, Notification and Review”

Title of document
Proposed amendment to the “Regulation on Quasi-drug Approval, Notification and Review” (46 pages, available in Korean) (46 page(s), in Korean)

Description
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.

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/816

Objective
For balanced review of ‘quasi-drug products’ approval, notification and examination and strengthened safety management

Documents

• 19_1545_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 15/03/2019
• Reception: 15/03/2019
• Distribution: 18/03/2019
• Final date for comments: N/A
• Proposed date of adoption: N/A