1. Reasons for Amendment

With an amendment to the Pharmaceutical Affairs Act (Act No. 18307, promulgated on July 20, 2021, to be enforced on July 21, 2024 ) to obligate that safety information on drugs to be labeled in braille and codes for the conversion into voice or sign language videos on containers, packages or the insert papers of quasi-drugs designated by the Minister of Food and Drug Safety, define matters delegated from the Act and other matters required for the implementation thereof, such as details of subjects of labeling, labeling information, labeling method, and standards of quasi-drugs for persons with visual or hearing impairments, and with increased items with labeling obligations for quasi-drugs that fall under the items of Article 2, subparagraph 7, item A of the Pharmaceutical Affairs Act, such as sanitary pads, as the Rules on the Safety of Drugs, etc. was revised (December 7, 2022), to provide consumers with accurate information by offering recommended forms of labeling.

* Scope of labeling obligations, such as efficacy and effects, directions for use and dosage, precautions for use, and country of production and manufacturer information, extended 

2. Major Provisions

A. Define items to be indicated in braille and codes for the conversion into voice or sign language videos (Article 4-3 newly inserted, Attached Table 4 newly inserted) 

1) Specify widely consumed items among product groups, which persons with disabilities essentially use in everyday life, as quasi-drugs to be indicated in braille and codes for the conversion into voice or sign language videos and newly insert Attached Table 4.

2) May omit the labeling for packing units with a narrow labeling surface on the  container or packaging and for some items in a package item, among quasi-drugs to be indicated in braille and codes for the conversion into voice or sign language videos.

3) Enable a review on items subject to labeling under paragraph 1 in order to facilitate persons with visual or hearing impairments’ use of quasi-drugs by referring to results of a survey, etc.

B. Define labeling to be indicated in braille and codes for the conversion into voice or sign language videos (Article 4-4 newly inserted) 

1) Specify the “name of quasi-drug” as the matter to be indicated in braille on the container or packaging.

2) Specify the name of the quasi-drug, trade name of the manufacturer (importer), dosage or weight, letters “quasi-drug,” efficacy and effects, storage method, directions for use and dosage, and precautions for use, as the matters indicated in codes on the container or packaging and provide as voice or sign language videos.

C. Define details of labeling methods and standards for codes for the conversion into voice or sign language videos (Article 4-5 newly inserted)

1) Define detailed methods and standards to label containers or packages in braille, such as the size of braille, standards to omit labeling, and location of labeling.

2) Define detailed methods and standards, such as standards and location of labeling of codes for the conversion into voice or sign language videos, and standards for voice or sign language videos to provide, in order to indicate codes for the conversion into voice or sign language videos on the container, package, or package insert of a quasi-drug.

D. For labeling of containers or packages of quasi-drugs that fall under the items of Article 2, subparagraph 7, item A of the Pharmaceutical Affairs Act, such as sanitary pads and masks, recommend labeling on the largest surface of the display location preferentially by referring to attached Forms 1 (Article 6)