ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Country | Korea | European Union | The United States | Germany | Japan | Ireland | |
|---|---|---|---|---|---|---|---|
| Braille | Braille regulations | Korean Braille Regulations [Ministry of Culture, Sports and Tourism Notice No. 2020-38 (September 10, 2020)] | Marburg Medium | Presented in ‘Let Your Fingers Do The Talking’ | While specific standards are not provided, it is recommended to follow Marburg Medium according to ISO standards. | N/A | Level 1 uncontracted Braille required It is recommended to follow Marburg Medium according to ISO standards. |
| Special notes | Prioritize pressed (perforated) Braille*, and consider methods such as stickers or embossed (transparent) Braille, taking into account the characteristics of the container and packaging materials, etc. | Abbreviated braille format for very small volumes (10 mL) | There’s no specific requirement for braille dot height, and for paper boxes, there is a possibility that embossed braille may revert over time, so it is advisable to determine it visually. | N/A | Methods of tactile identification include Braille, embossed letters, symbols, and cutouts. | A space is required between the quantity and the unit (e.g., 50 mg). | |
| Labeling location | On the front of the main display, it should be positioned at least 4 mm away from the edge of the medicine container at the upper right corner. | On external/double packaging and (foldable) paper boxes For large volume bottles (500 mL, 1 L), adhesive Braille labels can be attached during the manufacturing process. | A gap of more than 8mm from the cutting edge of the paper box Specify the number of Braille embossed characters that can be included based on the size of the paper box. | External packaging | Generally, it is recommended to be placed at the initial point of contact or at the location of the product that is always touched during use, and displayed in multiple locations rather than just one. | More than one side of the carton or in a different orientation than the printed text | |
| Braille display items | Product Name | Obligation Mark as permitted (reported) | Mandatory | N/A | Mandatory | N/A | Mandatory |
| Content of Ingredients | Conditional obligation If the content is sold in two or more different quantities, indicate the quantity in Braille as well. | Mandatory | N/A | N/A | N/A | Conditional obligation If the content is sold in two or more different quantities, indicate the quantity in Braille as well. | |
| Formulation | Conditional obligation If the content is the same but the formulation is different and the package is approved (reported) as a single item, the formulation of the product is also indicated in Braille. | Recommendation | N/A | N/A | N/A | Conditional obligation (in cases where confusion may arise) Even if the pharmaceutical product exists in only one formulation, it should not be indicated in Braille using an abbreviated formulation. The formulation should either be omitted or displayed in its full formulation term. |
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| Expiration date | Possible | N/A | N/A | N/A | N/A | N/A | |
| Can be omitted | The main ingredient name and content unit (e.g. mg or milligram) can be omitted. | For pharmaceuticals approved with a single content level, the content can be omitted. | N/A | N/A | N/A | N/A | |
| Others | In addition to the product name, pharmaceutical information (company name, expiration date, etc.) can be added in Braille. | It is recommended to indicate the intended user (whether for infants, children, or adults). If the product contains up to 3 active substances, the use of the International Nonproprietary Name (INN) is recommended. | There are Braille regulations for prescription medication containers, but there are no mandatory requirements or mandatory items. | N/A | N/A | N/A | |
| Specific Considera tions for Each Type of Pharmace utical | N/A | In case of herbal medicines, the content is omitted. For products that can only be administered by medical professionals, such as vaccines, both product name and content are omitted. For small volume products (up to 10 mL), where space is limited, consider alternative solutions such as supplemental ‘tab’ labels, abbreviated braille methods, and the use of defined abbreviations. | N/A | Braille labeling is an exception for pharmaceuticals released to the market in quantities of 7,000 packs or fewer. Braille labeling is an exception for pharmaceuticals intended for use by health professionals only. Braille labeling is an exception for pharmaceuticals with a container volume of 20 mL or less, or a weight of 20 g or less. | N/A | For bulk prescription packs managed by healthcare professionals, braille labeling is not applied. (Additional explanation is required in the braille report) Ointments with a pack size of less than 10 mL may use the abbreviation ‘o*t;t’. (Including English text and explanation is required in the braille report) | |