Korea, Republic of | Proposed amendments to the “Regulation on Labels of Quasi-Drugs”

Title of document
Proposed amendments to the “Regulation on Labels of Quasi-Drugs”

This text is a notification from the Ministry of Food and Drug Safety regarding proposed amendments to the "Regulations on the Labeling of Non-prescription Drugs" in accordance with Article 65-4 and Article 65-5 of the "Pharmacist Act." The purpose of these amendments is to reduce health-related issues caused by the misuse of non-prescription drugs by individuals with disabilities.

1. Reason for Amendments: The amendments are being made to enforce the mandatory labeling of safety information for non-prescription drugs in Braille and audio/sign language video conversion codes. These amendments are in response to the revision of the "Pharmacist Act" (Law No. 18307, July 20, 2021, enforced on July 21, 2024), which designated non-prescription drugs for visual and hearing-impaired individuals as subjects of labeling and established specific requirements. The amendments also align with the expansion of mandatory labeling items, such as efficacy, dosage, usage instructions, and manufacturer information, according to the "Regulations on the Safety of Medicines and Others" revision (December 7, 2022).

2. Key Contents of the Amendments: a. Definition of non-prescription drugs that require Braille and audio/sign language video conversion code labeling (newly added Article 4-3 and Appendix 4). b. Specification of the items to be labeled in Braille and audio/sign language video conversion code (newly added Article 4-4). c. Detailed regulations on the method and criteria for labeling Braille and audio/sign language video conversion codes (newly added Article 4-5).

3. Submission of Opinions: Interested parties or individuals can submit their opinions on these proposed amendments by November 20, 2023. They should address the following points:

   • Their stance (support or opposition) and the reasons behind it.
   • Their name (or organization name), address, and contact information.
   • Any additional comments or considerations.

It's important to note that the content of these amendments may be subject to further changes if the underlying regulations are modified. Additionally, a regulatory impact analysis will be conducted to assess the effects of these amendments during the public consultation period.

Notification: G/TBT/N/KOR/1171

Objective tag
Consumer information, labelling (TBT)

Documents

• 23_12585_00_x.pdf

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 25/09/2023
• Final date for comments: N/A
• Proposed date of adoption: N/A