Ministry of Health and Welfare notification 2011- 58

I hereby revise the Controlling and indicating barcodes of pharmaceutical products as

below, according to [Implementing regulation in Pharmaceutical Affairs Act, article 75
paragraph 1 subparagraph 9]
2011 May 31
Minister of Health and Welfare
Whole revision of Controlling and indicating barcodes of pharmaceutical products
The entire part of Controlling and indicating barcodes of pharmaceutical products is revised
as below.
The name of Controlling and indicating barcodes of pharmaceutical products is amended to
Using and controlling barcodes and RFID tags of pharmaceutical products.
Article 1(Purpose)
This notification is based on Implementing regulation in Pharmaceutical Affairs Act article
75 Paragraph 1 Subparagraph 9, and purposed to build the base of distributional information,
reducing distribution cost and efficient history control by determining details about
barcodes/RFID tag usage and controls of domestically manufactured or imported
pharmaceuticals.
Article 2(Definition) Terminology used in this notification is defined as below.
1. KD code; Korea Drug Code is the numbers designated to distinguish each individual
pharmaceutical products, and is 13 digits including Country code, Identifying code for the
party who obtains license or approval and importer of the pharmaceuticals (will be called
Manufacturer from now), Item code and Check digits, and its system is explained in
Appendix 1.
2. Pharmaceutical barcode is a printed symbol(mark) that is composed of a blank or an
optical Character Recognition font per each of the following item, which automatically input
data from the 13 digits of numbers in KD code to the computer with a certain rule, and can
be readable by scanners.
A. Combination of Black and white parallel sticks, having various widths
B. Data matrix composed of square-shaped module set with fixed arrangement
3. Pharmaceutical RFID" is a way that expresses information from the KD code (13 digits,
according to the article 1) excluding check digits and adding distribution identifier and serial
number, using Radio Frequency Recognition technology, and is composed of following
items.
A. RFID tag composed of antenna and chips
B. RFID reader that reads RFID tag
Article 3 (objects and obligator) Manufacturer must adhere or indicate barcode or RFID tag
to distributed pharmaceuticals that are domestically manufactured or imported (excluding
high pressure gas for medical use, drug substances manufactured just for other
manufacturing process, herbal medicines, product for clinical trials).
However,
pharmaceutical barcode or RFID tag can be omitted for empty capsules.
Article 4 (indicating barcodes, etc.) Pharmaceutical barcode or RFID tag must be
adhered to primary, secondary and external containers as well as packaging materials, per
items, and per packaging units.
Pharmaceutical barcodes and RFID tags must be cared so not to be damaged or wiped
out in distribution step.

Article 5 (types of barcode and component system) In case of indicating barcode

according to the article 4 paragraph 1, international standard barcode, GTIN-13 or GS1-128
code (one of the GS1 system) must be used.
Nevertheless , ethical drugs according to the article 2 paragraph 10 of the
pharmaceutical affairs law (excluding radio pharmaceuticals, orphan drug, cell therapy
product), or designated drugs according to its ordinance appendix 5, paragraph 2, B,
international standard barcode (defined in ), GS1-128 code must be used. However, in
case that GS1-128code is used to external containers and packaging materials, GTIN-13
can be used to primary containers and packaging.
The component system of pharmaceutical barcodes is described in appendix 2.

When indicating pharmaceutical according to , printing size, color and position of the
barcode is explained in appendix 3.

When barcode is used to control pharmaceutical distribution, GTIN-14 or GS1-128 code

(one of the GS1 system) can be used using KD code component system is described in
appendix 4.
Article 6 (RFID tag component system, etc.) In case of indicating RFID tag according to
the article 4 paragraph 1, SGTIN-96 or SGTIN-198 should be used (one of the GS1 system)
However, in case that RFID tag is used, GTIN-13 can be used to one of primary or external
containers or packaging materials.
In case that Pharmaceutical RFID tag should be used, manufacturers should notice the
minister of health and welfare that the expiry date of shelf life, lot number that matches each
serial number before sales, in order to control distribution and stock effectively.
The minister of Health and Welfare, according to the paragraph 2, should establish
database with the information noticed, and can offer this to wholesalers, medical institute,
pharmacy, and consumers.
The component system of pharmaceutical RFID tag is described in appendix 5.

The standard and adhesion method of pharmaceutical RFID tag are described in
appendix 6.

Article 7 (submitting product information report, etc.) According to the paragraph 69 of

the pharmaceutical affairs law, manufacturers should directly register product information
report (appendix1) of the items that they want to manufacture/import, to the portal website
(will be called portal from now) run by minister of Health and Welfare, per items, packaging
units, in 30 days from the date that the manufacturer received approval notice with regards
to article 31 and 42 of the pharmaceutical affairs law. However, pharmaceuticals which
do not have to have the approval or notification process, the registration should be done
within 30 days from the standard customs report, according to article 49 of the Ordinance the
pharmaceutical affairs law Nevertheless the ordinance of the pharmaceutical affairs law
appendix2, in case that the manufacturer inevitably requires to assign KD code prior to
approval, in order to do predict validation, product information report can be registered in the
portal.
Minister of Health and Welfare should announce the standard code of the item within 10
days from the product information report.

According to , in case that standard code should be newly assigned due to package
material/unit/item change of the item, the requestor must register the product information
report (appendix 1) to the portal immediately, and the minister of Health and Welfare should
announce standard code, in comply with .
In case that want to change the contents in product information report registered in
comply with , and , the change should be posted in the portal directly by the

requestor, at least 10 days prior to sell the product.

Minister of Health and Welfare should establish database, with the registered product
information report contents.
Article 8 (Securing information) Anyone who gets to know the confidential information of
manufacturer or product must not tell others and use it except for business.

Article 9(Other details) Minister of Health and Welfare can set up a guideline if needed, for
better control or management of the pharmaceutical barcode/ RFID systems.
Article 10 (re-evaluation period) According to the guidelines for issuing/controlling
anweisungs and regulations (presidential directive 248), considering change of the
legislation, practical condition after enactment of this notification, the deadline for abolition,
revision, etc. of it is decided to 2014 March 31.
Additional Clauses
Paragraph 1 (Implement date) This notification will be implemented from 2013 January 1.
Nevertheless , the article 7 paragraph 2 will be implemented from 2011 July 1.
Nevertheless , the article 5 paragraph 2 will be implemented as below:
1. For designated pharmaceutical, it is implemented from January 1st, 2012.
2. For ethical drugs, it is implemented from January 1st, 2013.
The addition of serial number defined by of appendix 2 will be implemented from
January the 1st, 2015.

Paragraph 2 (Technological/Economical Evaluation) Minister of Health and Welfare should

evaluate technological/economical evaluation on using GS1-128 code by June 2011.

Date
Applicant

Name
Email

Tel
Fax

I register the product information report in compliance with the [Controlling and indicating barcodes of pharmaceutical products].
Minister of Health & Welfare

Sales Status

Place Of Origin
Classification

Safe Container

Storage Method

Storage Type

Specially Controlled
Pharmaceuticals
Classification

CLASS

No. Of Total Products

Author

No. Of Items In
Packages

Manufacturer
code

Package Type

Address

Dosage Form
Classification

Manufacturer

UNIT

NO.

Administration Route

Formulation
Classification

English Product name

Korean Product name

Kfda Item Specification

Code

Classification

[Enclosure form1] (front page)

Product Information Report

Spec

(back page)
Details of product information report
Items

Digits

Details

1. KFDA item specification code

9-digit number including years shown at the bottom of the product license or product information in e-government sevice centre (for drugs)
(ezdrug.kfda.go.kr).

2. Product name(Korean)

48

Korean product name based on the product package (if different from KFDA manufacture(import)license, write

both names)

3. Product name(English)

36

English product name based on the product package (if different from KFDA manufacture(import)license, write

both English product names)

4. Formulation classification

01:transdermals, 02:gels, 03:granules, 04:preparations for irritation, 05:lemonades, 06:lotions, 07:liniments, 08:aromatic waters, 09:acid solution,
10:syrups, 11:ophthalmic ointments, 12:liquids, 13:aerosols, 14:extracts, 15: elixir, 16:ointments, 17:fluidextracts, 18:emulsion and suspension
19:implants, 20:decoctions and infusions, 21:nasal solutions, 22:ophthalmic solutions, 23:eardrops, 24:pills, 25:suppositories, 26:injection, 27:spirits,
28:plasters, 29:cataplasms, 30:capsules, 31:creams, 32:troches, 33:tinctures, 34:pastes, 35:pills, 36:inhaler, 37:others

5. Administration

01:Oral, Injection (02:vein, 03:artery, 04:subcutaneous, 05:intracutaneous, 06:abdominal cavity), mucous membrane (07:ear, 08:nose, 09:eye,
10:oral, 11varina, 12:anus, 13:pulmonary), 14:external use, 15:, 16:others, 17:muscles(injection)

No.

Write numbers excluding units

unit

01:g 02:mg, 03:kg, 04:g, 05:ml, 06:l, 07:IU, 08:unit, 09:mCi, 10:Others

7. Dosage form
classification

01:tablet, 02:capsule, 03:ampoule, 04:vial, 05:piece, 06:sheet, 07:pocket, 08:tank, 09:pill, 10:, 11:tube, 12:set, 13:others

8. Package type

01:ampoule, 02:bottle, 03:pocket, 04:tube, 05:PTP, 06:foil, 07:Vial, 08:can, 09:PFS, 10:bag, 11:pack, 12:kit, 13:pen, 14:penfill, 15:tank, 16:stick,
17:others

6. Specification

9. Item quantity in a package

integer

Number of items in a package unit

10. Total product quantity in a

package

integer

Total quantity of the product in a package unit

11. Drug classification

01:general drug product,02:ethical drug product,03:general drug product (sub division),04:ethical drug product (sub division),05:in vitro
diagnostics(general),06:in vitro diagnostics(ethical),07:drug substance(manufactured),08:drug substance(subdivision),09:others

12.
Special
controlled
pharmaceuticals classification

01:narcotics,02: psychotropic drug,03:including non-addictive drug,04:misuse/abuse concerned drug,05:biological formulation,06:biological

formulation, etc. (except biological formulation) 07:radiopharmaceuticals,08:orphan drugs,09:N/A

13. Storage type

01:sealed container,02:airtight container,03:hermatic container,04:shaded sealed container ,05: shaded

container,07:others

14. Storage

01:dark, 02:cold, 03:cold&dark, 04:dry&cold&dark, 05:dry&cold, 06:protected from light, 07:refrigeration, 08:room temperature, 09:ordinary
temperature, 10:freeze 11:others

15. Safe container

01:safe container, 02:N/A

16. Place of origin classification

National code defined by ISO

Ex) KR , US, JP

17. Sales permission

01:Sales permission, 02: Conditional permission (Bioequivalence or equivalence tests)

airtight container,06:shaded hermatic

[Appendix 1]
Component system of KD code (Regarding Article 2 Paragraph 1)

Digits(13)

Item code
Contents

Country code

Manufacturer
code

Check
Packaging digit
unit

Item code
including
contents

6400-6999
Examples

880

6200-6299

0001-9999

1-9

0-9

0500-0999
* Check Digit
Numbers set up for preventing barcode misreading barcodes and enhancing reliability,
calculated by a certain rule.
< Calculation >
GTIN-13
880

6411

12345

Country code

Manufacturer code

Item code

Check digit

Numbering starts from the right side of the code.

Code :

Location: 13 12 11 10 9

1
8

2
6

4
4

Calculated as below, based on the position of items.

Add all of the eventh numbers (in ).
5 + 3 + 1 + 1 + 6 + 8 = 24

Result of above: 3 = 243 = 72

Add all of the odd numbers except for check digits.

4 + 2 + 1 + 4 + 0 + 8 = 19

Addition of 72 from , and 19 from results in 91.

Lastly, from subtract 91 from a multiple of 10.

However, in this case the multiple of 10 is the smallest number that is bigger than 91(100).
100-91=9 check digit
If the result of calculation is "0", "0" is the check digit.
GS1-128
The calculation method of GS1-128 check digit can be expressed as barcode because the
barcode symbol software processes the function, but not expressed as numbers.

[Appendix 2]
Component system of Pharmaceutical barcodes
(Regarding Article 5 Paragraph 3)

Numbering
system
Symbol name

GTIN-13

GS1-128

EAN-13

GS1-128

GS1 Datamatrix

GS1 Datamatrix

EAN-13 symbol : 13 digits

Maximum digits

GS1-128 symbol : less than 48 digits (including numbers, letters)

GS1 Datamatrix symbol : less than 2335 digits
(including numbers, letters)

*Datamatrix means ECC 200 version, which should follow GS1 standard
*When in shortage of surface, readable letter of datamatrix symbol can be omitted.
1. GTIN-13 numbering system

Digits

Contents

Country code

Manufacturer code Item code

Check digit

Examples

880

6411

12345

(01)08806411123459
2. GS1-128 numbering system
To GTIN-13 numbering system, add expiry date of shelf life, lot number and serial number to
application identifier, and also other application identifier that manufacturer(importer) think to
be necessary can be written according to KS standard (standard number: KS X 6705).

Application
identifier

01

17

10

21

Definition

GS1 Product
code

expiry date of
shelf life

Batch or Lot
number

Serial number

Data format

n14

n6

an..20

an..20

Example of GTIN-13(Manufacturer code:6411, Product code:12345) expiry date of

shelf life(20101231), Lot number (Q12345) and Serial number(A213291199)

digits 2

14

Below
20

Below 20

C
O
N
T
E
N

AI
AI
product GS1
identifying code
code

expiry
AI Product
AI
product
product date
YYMMDD Lot manufactured Serial Serial
of
no. line
number number
shelf
life

s
Ex)

(01)

08806411123459 (17)

101231

(10) Q12345

(21)

A213291199

* But, next to lot number data, you should place filed separation letters, <GS> or
FNC1(ASCII value 29), so it can be distinguished from serial number.

(10)Q12345(21)A213291199

(01)08806411123459(17)101231

[Appendix 3]
Size, color and position of pharmaceutical barcodes
(Regarding the article 5 Paragraph 4)

classification

EAN-13

GS1-128

GS1 Datamatrix

- Width 3.73height
2.59

- Width: less than 16.5

Printing size - Print 0.82.0 times

- Height: 1.33.2
size within the range that
- 0.251.0 times
the barcode can be
scanned

Printing
color

- Contrast between white

and black bars: more
- Contrast between white
than 75%
and black bars: more
than 75%
- Only black and white
bars are recommended - Only black and white
- Metal color (gold, silver) bars are recommended
must not be used.

- Density (X-Dimension)
Higher than 0.25
recommended

- Contrast between white

and black bars: more
than 75%
- Only black and white
bars are recommended

- Easily readable position - Easily readable position

Printing
position

- Upward limit 8
recommended

- Upward limit 8
recommended

- Surface having less

than 30 curve

- Surface having less

than 30 curve

- Easily readable position

- Surface having less
than 30 curve

[Appendix 4]
Component system of pharmaceutical distribution barcode
(Regarding the article 5 Paragraph 5)
1. Types of pharmaceutical distribution barcode and its component system
Numbering
system
Symbol name

GTIN-14

GS1-128

ITF-14

GS1-128

GS1 Datamatrix

GS1 Datamatrix

ITF-14 symbol : 14 digits

Maximum digits

GS1-128 symbol : less than 48 digits(including numbers, letters)

GS1 Datamatrix symbol : less than 2335 digits including numbers
and letters

*Datamatrix represents ECC 200 version, GS1 standard should be complied.

*When lack of space, readable text in Datamatrix symbol can be omitted.
A. GTIN-14 numbering system
Digits
Contents

Distribution

Country
identifying

Manufacturer

880

6411

identifying

identifying

Item code

Check digits

12345

1
Examples

(18 available)

(01)18806411123456
B. GS1-128 numbering system
To GTIN-14 numbering system, add expiry date of shelf life, lot number and serial number to
application identifier, and also other application identifier that manufacturer(importer) think to
be necessary can be written according to KS standard (standard number: KS X 6705).

Application
identifier

01

Definition

GS1 product code expiry date of shelf life

Batch or Lot
number

Data format

n14

an..20

17

10

n6

Example of adding expiry date of shelf life (20101231) and lot number (Q12345) to GTIN14(distribution identifying:1, Manufacturer code:6411, productcode:12345)
Digits

Contents

AI
AI product
GS1 product code expiry date
identifying code
of shelf life

Product
YYMMD AI lot
produced
D
number
line

Example

(01)

101231

(17)101231(10)Q12345

(01)18806411123456

14

18806411123456

(17)

(10)

20

Q12345

2. Printing size, color and position of pharmaceutical distribution barcode

classification ITF-14

GS1-128

GS1 Datamatrix

- Width 14.28height
Printing size 3.20
- 0.251.0 times
Same as

Printing
color

[Appendix 3] Printing size, color of

- Contrast between white pharmaceutical barcodes
and black bars: more
than 75%
- Only black and
white(back ground) bars
are recommended

- At least more than 2

faces of the box
(adjacent faces)
Printing
position

- box bottom length

longer than 323
- right/left edges more
than 19

- For boxes, identical to

ITF-14
- palette bottom
4080
More than 50 from
edges

- Easily readable
position

- Upward limit 8

3. Calculation of check digits

A. GTIN-14
GTIN-13 calculation of [Appendix 1], input distribution identifying code and do the
calculation, other than that, identical to GTIN-13.
B. GS1-128

Same as [Appendix 1] GS1-128 calculation.

[Appendix 5]
Component system of pharmaceutical products RFID tag
(Regarding the article 6 Paragraph 4)
SGTIN-96 and SGTIN-198 consist of 12 digits (except check digit) from pharmaceutical
standard code 13 digits and include distribution identifier, serial number, as below.
1. SGTIN-96
classificationHeader1)

Filter2) Partition3)

Manufacturer
code

Serial
Product
number4)
code

no. of bit

24

20

00110000

Standard
filter
101
value

distribution5)
identifier

item
code

digits

(set value)

Manufacturer
Country
classification code identifying
code

<Pharmaceutical
standard code>

digits

38
274.8 billion
(max.)

2. SGTIN-198

Header1)

classification
no. of bit

digits

Filter2) Partition3)

00110110

Standard
filter
101
value

(set value)

Manufacturer
code

Product
code

24

20

140
20 digits
(max.)

Manufacturer
<Pharmaceutical
Standard code>

Serial number4)

classification Country code identifying

Product
distribution5) identifier code

code
digits

1) Header: Defines code length and identifying code type, and the structure. It is a binary
numeral value, for 0011 0000 SGTIN-96 applied, and for SGTIN-198 0011 0110 is
applied.
2) Filter: An identifier to express distribution units of item and inner package, for a
pharmaceutical, binary numeral value 001 is applied.

Filter

Meaning

Filter

Meaning

000

All Others

100

Bundle of dealing items that are

not going through counter

001

Retail item

101

Not in use yet

010

Bundle of standard dealing

110
item

Not in use yet

011

Single loaded/customer deal

111
item

Not in use yet

3) Partition: an identifier for the length of manufacturer code and product code classification,
binary numeral value 101 is applied, which corresponds to 7 digits of manufacturer code, 6
digits of product code.
4) Serial Number: Consecutive number assigned for individual product identification, SGTIN96 can be composed of numbers, encode binary numeral converted from decimal numeral,
for SGTIN-198 English letters and numbers both can be used, encode individual
letter/number repeat it every 7 bits using ISO/IEC 646(ASCII).
5) Distribution identifier: It does not exist in KD code, but added to be consistent with
barcode standard GTIN-13. When apply to a single drug item, binary numeral value 000 is
applied.

[Appendix 6]
Specification and adherence method of pharmaceutical RFID tag
(Regarding the article 6 Paragraph 5)
1. RFID tag specification
A. 900MHz ranged manual RFID tag which complies with ISO 18000-6C should be used.
B. A tag that has CoA of several tests including reliability tests (movement at high/low
temperatures, high temperature and humidity, varying temperature, etc.), tag RF/Protocol
standard test and interoperability test from an official test institute is recommended.
C. A RFID tag should be readable at least from 1m distance.
2. RFID tag adhesion method
A. General specification
RFID tag should be adhered without disrupting usage and storage of the pharmaceutical.
B. Adherence of different packaging materials
It should be adhered steadfastly to paper box, plastic/ glass and film packaging materials so
scanning tag is not to be disturbed in the distribution step.
3. RFID reader
A. Use of 900MHz ranged manual reader [KS x ISO/IEC18000-6C] is recommended.
B. The reader that has CoA with the result of standard specification test issued from official
test institute is recommended to be used.