1. Reasons for Amendment

 The Pharmaceutical Affairs Act was amended (Act No. 18307; promulgated on July 20, 2021; to be enforced on July 21, 2024) to mandate the use of braille and codes for conversion into voice or sign language videos in the indication of drug safety information on the containers, packages, and insert papers of drugs specified by the Minister of Food and Drug Safety to prevent health hazards arising from the misuse of drugs by persons with visual or hearing impairments. Accordingly, this Amendment prescribes drugs subject to labeling for persons with visual or hearing impairment, information provided on labels, details on the labeling method and requirements, and other matters delegated by the Act and matters necessary for the enforcement thereof.

2. Major Provisions

 A. Designate items subject to labeling using braille and codes for conversion into voice or sign language videos (Article 6-3 (1) and attached Table 2-3 newly inserted)

 B. Prescribe matters to be indicated using braille and codes for conversion into voice or sign language videos (Article 6-3 (2) newly inserted)

 C. Prescribe the specific labeling method and requirements for braille and codes for conversion into voice or sign language videos (Article 6-3 (3) and (4) newly inserted)