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Global Market Intelligence ServiceSerialization Regulation Report

South Korea White Paper

August 15, 2014 Version 3

Table of ContentsExecutive Summary.....................................................................................................................................3

Compliance Dates........................................................................................................................................4

Korea Drug Code.........................................................................................................................................5

Labeling at the Saleable Unit.......................................................................................................................6

Requirements for the addition of serial number will take effect on January 1, 2015:..............................7

Print Size, Color, and Position of the Drug Bar Code At the Saleable Unit Level.......................................8

Labeling of the Shipper Case and Logistics Unit Level.................................................................................9

Encoding a GTIN-14 at the Distribution Level...........................................................................................9

Requirements for Print Size, Color, and Position of Drug Distribution Bar Code....................................10

Computation of the Check Digit for Korea Drug Code (GTIN-13)............................................................11

References.................................................................................................................................................12

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Executive SummaryAll regulations examined in this report are laws that have been enacted by the Korea Food and Drug Administration (KFDA) and Ministry of Health & Welfare (MoH). Clear timelines have been established for drug manufacturers to adhere to regarding label requirements on the saleable unit and the case level. It is critical to distinguish which timeframe certain regulations refer to when reviewing this report, as both current labeling requirements and January 1, 2015 serialization requirements are examined in the body of this document.

The Korean Pharmaceutical Information Service (KPIS) also influences serialization requirements. The core function of the KPIS is to collect, study, process, utilize, and provide pharmaceutical distribution information with regards to manufacturing, import, supply and consumption activities. Other works of the KPIS include management of Korea Drug codes (including bar codes), information support activities such as development and promotion of programs for collecting distribution information, and research, education for standardisation as well as distribution innovation.1

When a drug is required to have a bar code, GS1 standards will be applied. Korea Drug Code is comprised of 13 digits and can be directly converted into a GTIN-13. The addition of an indicator digit to the Korean Drug code creates a GTIN-14 (the check digit will be impacted), which will be encoded in a GS1 Data Matrix. A GS1-128 linear bar code may also be used to satisfy requirements.

The use of RFID tags are also acceptable and if RFID is implemented, SGTIN-96 or SGTIN-198 should be used in accordance with the GS1 system. In case that an RFID tag is used, GTIN-13 can be associated to the primary or external containers or packaging materials. If the pharmaceutical RFID tag is used, manufacturers should notify the Minister of Health and Welfare of the expiry date and lot number that matches each serial number before sales, in order to control distribution and stock effectively.

While standards in Korea vary from other countries, the regulations accomplish the same goal: preventing counterfeit, diluted, and adulterated drugs from entering the supply chain. The contents of this report are intended to educate the reader of the specific guidelines the KFDA, MoH, and KPIS have outlined to ensure legitimacy throughout the supply chain and ultimately guarantee patient safety.

1 GS1. GS1 Healthcare Reference Book 2011/2012

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Compliance DatesJanuary 1, 2012: Data carrier containing GTIN, expiry date, lot number must be affixed on specified (narcotic) drugs.

January 1, 2013: Data carrier containing GTIN, expiry date, and lot number must be affixed on the prescription drugs.

October 31, 2014: Companies are advised to submit a serialization implementation plan to Korean Ministry of Health in order to extend serialization deadline

January 1, 2015: Companies must serialize the products accounting for the top 30% of their sales or 30% of their products. Data carrier containing a serial number, GTIN, expiration, and lot must be affixed on the narcotic and prescription drugs. Note: All Psychotropic and Biologicals must be serialized by January 1, 2015 deadline.

January 1, 2016: All Pharmaceutical Product must be serialized.2

Implementation dates pertain to manufacturing date for domestically manufactured pharmaceuticals, and customs clearance date for imported pharmaceuticals.

2http://www.mw.go.kr/front_new/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=1&CONT_SEQ=304380&

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Korea Drug Code Drug standard code (KD code or Korea Drug Code) is a number uniquely assigned for identification of an individual drug product. The code is composed of a 13 digit number including the country identification code, the company identification code, the item code, and the verification number (check digit). A GTIN-13 is identical to the Korea Drug Code. By adding an indicator digit to specify the level of packaging, a GTIN-13 can be converted to a GTIN-14. This may also impact the check digit. Table 1 shows the code system.

Components of Korea Drug Code

Number of digits (13) 3 4 5 1

ContentCountry identification code

Company identification code

Item codeVerification code*Contents

includedPackage unit

Example of issuance 880

6400-69990001-9999 1-9 0-96200-6299

0500-0999*Verification code (Check Digit)

Table 1

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Labeling at the Saleable UnitIn South Korea, there are two options for labeling at the saleable package level. Either a GS1 Data Matrix or GS1-128 linear bar code can be used to comply with regulations.

To meet January 1, 2013 requirements, GTIN, lot, and expiration must be embedded in the data carrier. Human readable elements may be excluded if there is a limited amount of packaging space. Assuming GTIN, lot, and expiry data are encoded in Figures 1 and 2, these are acceptable examples to meet Jan 1, 2013 requirements.

When the data carrier is a GS1 Data Matrix (or GS1-128 linear bar code), the Korean Drug Code should be converted to a GTIN-14 (by addition of an indicator digit) to satisfy AI (01) requirements. This is necessary as AI (01) requires a data field length of 14 digits.

GTIN-13 Numeric StructureDigits 3 4 5 1

ContentCountry identification code

Company identification code

Item code

Verification number

Issuance Example 880 6411 12345 9

Table 2

January 1, 2013 requirements:

Figure 1

(01)08806411123459(17)101231(10)Q12345

Figure 2

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Requirements for the addition of serial number will take effect on January 1, 2015:

Application Identifier Description Number of Characters(01) GTIN 14(17) Expiration Date 6(10) Lot Number Equal or less than 20(21) Serial Number Equal or less than 20

Table 3

This GS1-128 linear bar code will comply with January 1, 2015 regulations.

Figure 3

This GS1 2D Data Matrix will comply with January 1, 2015 regulations.

(01)08806411123459(17)101231(10)Q12345(21)A213291199

Figure 4

If there is not enough space, human readable characters may be omitted.

In regards to January 1, 2015 regulations, if a saleable unit contains an outer box and a primary package, the serial number should accompany the outer box in addition to GTIN, lot, and expiration date. The primary package may contain only a GTIN. Although, it is preferred both the outer box and primary package contain identical serial number, GTIN, lot, and expiry date. The drug bar code must not be susceptible to damage or removal.

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Print Size, Color, and Position of the Drug Bar Code At the Saleable Unit Level

GS1-128 GS1 Data Matrix

Print Size

Width: Equal to or less than 16.5cm

Density (X-Dimension)

Height: 1.3cm～3.2cm

Over 0.25mm recommended

Print Color

1. Contrast ratio between black & white bar over 75%

1. Contrast ratio between black & white bar over 75%

2. Only black & white bars (background) are recommended

2. Only black & white bars (background) are recommended

Print Position

- Easily visible position

- Easily visible position

- Rise limit 8mm recommended

- Curve less than 30°

- Curve less than 30° Table 4

Explanation of a Curve Less than 30°

Figure 5

1. The outer edge of the first strip2. The middle of the Medicine Electronic Administration Code Symbol3. The outer edge of the last strip4. The outer edge of blank spaces on the right side and left side5. The Medicine Electronic Administration Code Symbol6. The surface of the drug package7. The generatrix of the curved surface8. The surface curvature of the Medicine Electronic Administration Code Symbol

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Labeling of the Shipper Case and Logistics Unit LevelThere are 3 acceptable data carriers at the distribution level: an ITF-14, GS1-128 Linear Bar Code, or a GS1 Data Matrix. The ITF-14 bar code will only meet current labelling regulations, but is not capable of meeting serialization requirements as in can only encode a GTIN. To meet January 1, 2015, requirements, GTIN, serial number, lot, and expiration date must be encoded in the data carrier (GS1-128 Linear Bar Code or GS1 Data Matrix). When there is a lack of space on the packaging label, human readable elements may be omitted.

Encoding a GTIN-14 at the Distribution LevelGTIN-14 Numeric System For Distribution Packages

Digits 1 3 4 5 1

Content Distribution Identification

Country Identification

Company Identification

Item Code

Verification Number

Issuance Example

1

880 6411 12345 6(1-8 accepted)

Table 5

Maximum number of Digits

ITF-14 symbol : Numeric 14 digitsGS1-128 symbol : Less than 48 digits including numbers and charactersGS1 Data Matrix symbol: Less than 2,335 digits including numbers and characters

Table 6

ITF-14

GS1 Data Matrix GS1 128 Linear Bar Code

(01)18806411123456

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Requirements for Print Size, Color, and Position of Drug Distribution Bar Code

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Type ITF-14 GS1-128 GS1 Data Matrix

Print Size

Width 14.28cm×Height 3.20cm

Width: Equal to or less than 16.5cm

Density (X-Dimension)

Height: 1.3cm～3.2cmOver 0.25mm recommended

Print Color

Contrast ratio of between black and white bar

Contrast ratio between black & white bar over 75%

Contrast rate between black & white bar over 75%

over 75% contrast ratio

Only black & white bars (background) are recommended

Only black & white bars (background) are recommended

Only black & white bars (background) are recommended

Print Position

Box with at least 2 planes (contiguous)

Box is same as prescribed under ITF-14

Easily visible position

Box bottom over 32±mm

Pallet bottom 40～80cm

Box right & left edge over 19mm

Edge over 50cm

Rise limit 8mm

Computation of the Check Digit for Korea Drug Code (GTIN-13)The verification code, or check digit, is a number set to prevent bar code misreading and improvement of reliability when designating a drug standard code. It is the last digit of the GTIN-13. It is calculated by a specific set of rules applicable to a 13 digit Korea Drug Code. However, this calculation, called the Modulo 10 algorithm, is same for all GS1 primary identification numbers. Every time a computer decodes a GS1 barcode number it repeats the calculation and checks its answer against the check digit to verify the data integrity of the number. 3 See the example below to recognize how a check digit is calculated. The GTIN-14 code check digits (for any GS1 Datamatrix or GS1-128 carriers) must be calculated based on all 13-digits of the GTIN-14 base number (including the indicator digit).

ID KeyFormat

Digit positions

GTIN-8 N1 N2 N3 N4 N5 N6 N7 N8

GTIN-12 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12

GTIN-13 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13

GTIN-14 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14

SSCC N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14 N15 N16 N17 N18

Step 1: Multiply value of each position byx3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3

Step 2: Add results together to create sumStep 3: Subtract the sum from nearest equal or higher multiple of ten = Check Digit

Example

Positions N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13

Number without Check Digit

6 2 9 1 0 4 1 5 0 0 2 1 -

Step 1: Multiply x X X X X X X x x X X x -By 1 3 1 3 1 3 1 3 1 3 1 3 -Step 2: Add results = = = = = = = = = = = = -to create sum 6 6 9 3 0 12 1 15 0 0 2 3 = 57Step 3: Subtract the sum from nearest equal or higher multiple of ten = 60- 57 = 3 (Check Digit)Number with Check Digit 6 2 9 1 0 4 1 5 0 0 2 1 3

3 http://www.gs1.org/barcodes/support/check_digit_calculator

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References “Drug Bar Code Labels and Management”. KOREA Ministry of Health & Welfare Notice No. 2011-58, 31 May 2011.

GS1. GS1 Healthcare Reference Book 2011/2012

http://www.gs1.org/barcodes/support/check_digit_calculator

Pharmaceutical Affairs Act. Korea Food and Drug Administration, 7 June 2011.

http://www.mw.go.kr/front_new/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=1&CONT_SEQ=304380&

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