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Regulations in Turkey

TURKISH MINISTRY OF HEALTH

G.D. OF PHARMACEUTICALS AND PHARMACIES GUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE

Version 1.2 Ankara, 2009

Note: İtalics are changed in that version.

GUIDANCE ON IMPLEMENTATION OF IDENTIFICATION AND BARCODING OF MEDICINAL PRODUCTS FOR HUMAN USE

ARTICLE 1- (1) The objective of this guidance is to designate the principles relating to the identification and barcoding of medicinal products for human use for the purpose of tracking drugs. To serve this purpose, the guidance encompasses the relevant information for creating barcodes and printing.
ARTICLE 2- (1) This guidance has been drafted in accordance with Article 19 of the “Regulation Regarding the Packaging and Labelling of Medicinal Products for Human Use” published on the Official Gazette dated 12/08/2005, with No. 25904.
ARTICLE 3- (1) For the purposes of this guidance, the following terms shall apply:
a) Ministry: Republic of Turkey Ministry of Health,
b) Barcode Symbology: Method that will be applied in the coding and decoding of information on the barcode (e.g.: EAN-13 Barcode Symbology, GS1-128 Barcode Symbology, ITF-14, etc.)
c) Barcode: Technology consisting of a combination of lines of varying widths, spaces and numbers that allows numerical or alphabetical data to be transferred accurately and promptly to computers,
d) Bar-coding: Printing of data read by the barcode reader by using an appropriate barcode symbology and printing method on a specified surface,
e) Primary identifier: The barcode,
f) General Directorate: Pharmaceutical and Pharmacies General Directorate,
g) Group Separator: The character corresponding to FNC1 (function1) in the barcode symbology for GS1-compatible systems
h) GS1: International organization headquartered in Brussels that develops Effective Supply Chain Solutions and Standards, represented by TOBB-GS1 Turkiye in Turkey.
i) GS1 Application Identifier (AI): Data headings used in determining the meaning of data that will be transferred to information systems by the barcode reader (e.g. 01= GTIN, 17=expiration date),
j) GTIN (Barcode Number, Global Trade Item Number): Product number that allows commercial products to be uniquely identified on a global scale and whose content (structure) is specified by GS1,
k) Secondary identifier: The version named in data matrix symbology format and printed on medicinal drug packages of the information of which the contents and structure are laid out in this guidance,
l) Data Matrix Symbology: Two-dimensional barcode symbology that will take “ISO/IEC 16022 International Symbology Specification-Data Matrix ECC 200 Version” as its basis,
m) Pharmaceutical Code: A coding system based on the pharmaceutical presentation and administration of the product.
ARTICLE 4- (1) The following identifiers will be used in the identification of Medicinal Products for Human Use:
a) GTIN-Global Trade Item Number: This is a number composed of at most 14 digits used to uniquely identify products on a global scale. In circumstances when the commercial product is used at the retail sales point, the number placed on the product consists of the EAN-13 barcode symbology and has 13 digits. In such circumstances, the number “0” shall be placed before the 13-digit number and a 14-digit GTIN number will be composed.
GTIN consists of four parts. These are GS1 Country prefix, Company prefix, product reference number and check digit. The GTIN is determined by authorized/brand owners according to GS1 GTIN Allocation Rules.
Use of pharmaceutical code in GTIN is optional. If it is desired to use a pharmaceutical code, characters N9 and N10 may be used for pharmaceutical code.
The GS1 Application Identifier identifying the GTIN information is “01”.


Application Identifier (AI)
Barcode Number (GTIN)
Extension Digit
GS1 Company Prefix Product Reference

Control Digit
0 1
0
N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
N14


Example:


Application Identifier (AI)
Barcode Number (GTIN)
01
0
869123456789
0


b) Serial Number: This is a number used in identifying each unit of a product identified by GTIN. A serial number used for a product may not be used again for the same type of product. The serial number is of variable length and may contain 20 alphanumeric characters at most. The marketing authorization holder designates a unique serial number.
The GS1 Application Identifier identifying the serial number is “21”.


Application Identifier (AI)
Serial Number
21
X1 variable length                  X20


Example:


Application Identifier (AI)
Serial Number
21
1323424679


c) Expiration Date: It refers to the final date on which the product may be used safely. It is a numeric data composed of 6 characters. The format of the data shall be YYMMDD. YY will indicate the Year information in two digits, MM shall indicate the Month information in two digits whereas DD will indicate the day information in two digits. For example; in 120731, 12 indicates the year 2012, 07 indicates the month July and 31 indicates the last day of that month.
If the manufactured product has an expiration of more than one month, digit of last day of the month or “00” shall be used for the day field in the expiration date. Example: If the expiration is two years of a product of which the manufacturing date is July 12 2010, its expiration date is July 312012. This digit is indicated in the identifier in two ways: First is 120731 and second is 120700. Related software managed the digit “00” as the last day of that month.
The GS1 Application Identifier identifying the expiration date is “17”.


Application Identifier (AI)
Expiration Date
Year
Month
Day
17
N1 N2
N3 N4
N5 N6


Example: It indicates January 19 2007.


Application Identifier (AI)
Expiration Date
17
07
01
19


d) Batch/Lot Number: This is a number used to differentiate one batch/lot from others during production. The number which, earlier on, used to be referred to as “Serial Number” for Medicinal Products for Human Use will be referred to as “Batch/Lot Number” in the new system. The Batch/Lot Number is of variable length and may contain 20 alphanumeric characters at most.
The GS1 Application Identifier identifying the Batch/Lot Number is “10”.


Application Identifier (AI)
Batch/Lot Number
1 0
X1 variable length                 X20


Example:


Application Identifier (AI)
Batch Number
10
X2512061322


e) Group seperator (FNC1): This character, which is used as a character corresponding to FNC1 (function1) in the barcode symbology for GS1-compatible systems, shows barcode type when it is placed at the first or second position in the barcode symbology. In other positions, it is used as a character corresponding to field separator. When it used as a field separator in the data matrix, it is transferred to applications by being converted to ASCII 29 character. If another field follows a field of variable length, group separator is placed between these two fields.
(2) Only “0,1,2,3,4,5,6,7,8,9” numeric or “A,B,C,D,E,F,G,H,I,J,K,L,M,N,O,P,Q,R,S,T,U,X, W, V,Y,Z” alphanumeric characters could be used in serial number and batch/lot number areas in product encodings. Special symbols and small letters will not be used besides for these numbers and letters.
ARTICLE 5- (1) The GTIN (Barcode Number) in EAN-13 Barcode Symbology might be printed on the product package as the primary identifier.
(2) Data Matrix: All identifying information indicated in Article 4 will be included as secondary identifier in Data Matrix symbology on the package of the Medicinal Product for Human Use.
(3) The content of the new data matrix on the product shall be composed as follows.
a) The first character of the content of the data matrix shall always be the “Group Separator”. This character which indicates that the content is in harmony with GS1 will not be transferred to the computer applications by the readers.
b) The 14-digit GTIN which is applied with the Application Identifier 01 shall be added. The GTIN occupies a total of 16 digits in the data matrix, including the application identifier.
c) Serial Number: The Serial Number whose contents are determined by the manufacturer or importer, applied with the 21 Application Identifier, of variable length and may contain 20 characters at most shall be added. The Serial Number occupies a maximum of 22 characters, including the two-digit Application Identifier.
d) The Group Separator indicating the end of the Serial Number at variable length shall be added.
e) 17 Application identifiers and 6-digit date information shall be added. The expiration date occupies a maximum of 8 characters in the data matrix, including the two-digit Application Identifier.
f) Batch Number: 10 Application identifiers and the Batch Number (with 20 characters at most) at variable length shall be added. The Batch Number occupies a maximum of 22 characters in the data matrix, including the two-digit Application Identifier.
Example: GTIN: “08691234567890”, Serial Number: “1323424679”, Expiration Date: “January 19, 2007”, Batch Number: “X2512061322”. The content of the data matrix corresponding to this information shall be as follows. The Group Separator Character has been indicated as <FNC1>.
<FNC1>0108691234567890211323424679<FNC1>1707011910X2512061322
The data matrix corresponding to this content shall be as follows:
The data to be transferred to the computer upon the reading of the abovementioned data matrix shall be as follows:
0108691234567890211323424679<GS>1707011910X2512061322
It should be noted that the character <GS> containing the value ASCII 29 has been transferred as the Group separator to the computer application by the Barcode reader.
(4) The expiration date shall be written in the abovementioned format also for human readable information and will be printed separately according to provisions of the regulation in a different place other than this.
(5) The data matrix, as a Datamatrix barcode in ECC200 standards, may be printed in either the square or the rectangle form, as indicated in the mentioned standard. This printing form shall be determined by then manufacturer/importer.
(6) Use of Global GTIN numbers: If the products have GS1-compliant Barcode Number (GTIN) in the countries they are manufactured, these numbers may be used after being declared to the Ministry.
ARTICLE 6- (1) The following shall be included into the definitions of transport units for Human Use and Medical Purposes:
a) Bundles: Bundles are transport unit packages which tie a small number of products to each other. Bundles shall be prepared in a manner so as not to be easily ruined under a slight impact and will bear on top the transport package label designated for the transport package.
b) Boxes: Boxes resemble bundles, but in boxes the products are contained within a box. They are transport packages which avail of the characteristics for transporting the products to the pharmacies without being opened. The transport package label designated for the transport package shall be placed on the boxes.
c) Parcels: They are used for carrying a high number of products or a certain number of boxes or bundles. The transport package label shall be placed on the parcels.
(2) The following identifiers shall be used in identifying the transport units for Medical Products for Human Use and Medical Purposes.
a) Parcel Barcode Number (GTIN-Global Trade Item Number): The 14-digit number, which uniquely identifies the transport unit on a global scale. In circumstances where there is a product with the same GTIN in the transport unit, it shall be composed upon using the barcode number of the product. A value varying between 1-8 shall be used in the extension digit. In this case, the control digit corresponding to the 14th digit should be re-calculated.
If the transport unit contains products with different GTINs, a new GTIN number shall be generated according to the GTIN Allocation Rules, independent of the products the parcel contains. “0” shall be used as the extension digit.
The GS1 Application Identifier which identifies GTIN information is “01”.


Application Identifier (AI)
Barcode Number (GTIN)
Extension Digit
GS1 Company Prefix Product Reference
Control Digit
0 1
A value between 1-8
N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13
N14


E.g.: (01)18691234567897


Application Identifier
(AI)
Barcode Number (GTIN)
01
1
869123456789
7


b) Serial Number: It is the number used for identifying each transport unit defined with GTIN. The serial number used for a transport unit shall not be used once again for the same type of transport unit. The Serial Number is of variable length and may contain 20 characters at most. The serial number shall be designated by the registration/permit holders.
The GS1 Application Identifier defining the serial number is “21”.


Application Identifier (AI)
Serial Number
21
X1 variable length                 X20


Example:


Application Identifier
(AI)
Serial Number
21
5132342412


(3) “0,1,2,3,4,5,6,7,8,9” numeric or “A,B,C,D,E,F,G,H,I,J,K,L,M,N,O,P,Q,R,S,T,U,X,W, V,Y,Z” alphanumeric characters could be used in serial number and batch/lot number areas in transport unit encodings. Special symbols and small letters will not be used besides of these numbers and letters.
(4) The extension digit which is used in the transport unit GTINs may be used for classifying the transport units.
ARTICLE 7- (1) The Barcode Numbers on the transportation unit (GTIN) shall be printed in ITF-14 Barcode symbology, within the framework of current principles, for the purpose of identifying the variety.
(2) All descriptive data indicated in Article 6 shall be included on the transport unit packages of Medicinal Products for Human Use in the form in Data Matrix symbology or preferably a linear barcode with GS1-128 barcode symbology.
(3) The content of the new data matrix or linear barcode on the transport unit shall be composed as follows;
a) The first character of the data matrix content will always be the Group Separator. This character which indicates that the content is compatible with GS1 shall not be transferred to the computer applications by the readers.
b) The Application Identifier 01 and a 14-digit GTIN shall be added.
c) The Application Identifier 21 and a Serial Number of variable length shall be added, provided that it is composed of 20 characters at most.
Example: If GTIN is: “18691234567897”, the serial number shall be: “5132342412”
The data matrix content corresponding to this information shall be as follows. The group separator has been indicated as <FNC1>. It should be noted that as the information contains only one variable length, the character FNC1 is not used as a group separator.
<FNC1>0118691234567897215132342412

The datamatrix symbology corresponding to this content shall be as follows:
The barcode in GS1-128 symbology corresponding to the same content shall be as follows:
The data to be transferred to the computer applications pursuant to having read the datamatrix symbology or barcode indicated above shall be as follows:
011869123456789721B13234241234
(4) In the human readable area, the parentheses indicating the application identifiers will be for demonstrative purposes and will not be included into the content of the barcode or data matrix.

(5) If the label of the recommended transportation package is composed with a data matrix, the form of the label shall be as follows in whole or in part:

Or, if it is composed of a linear barcode, the label shall be as follows in whole or in part:
The figures above have been included for recommendation purposes; companies may designate these labels according to their demands and needs.
(6) If desired, more information can be added to the barcodes that will be placed on logistic units by using appropriate GS1 application identifiers
At the above example, when AI=37 is added to the secondary identifier of the number of products in package, the information that will be printed on the barcode is as follows:
<FNC1>0118691234567897215132342412<FNC1>37999
The application identifier of 37 shows the number of products in a logistic unit and it is a numerical value of variable length containing maximum 8 digits.
(7)There may be situations where the transport packaging would need to be used as outer packaging, in which case the datamatrix shall be applied on transport packaging as with the product’s outer packaging. For example, peritoneum dialysis solutions are shipped in multiples inside cardboard boxes. However, each of these products are priced individually and reimbursed accordingly. To facilitate reimbursement on these products, General Directorate of Pharmaceuticals and Pharmacies, issued a “List of Transport Packaged Products”; outer packages listed therein which hold multiple products must be datamatrix printed as a single product. Use of the multipliers specified on the list indicating product quantity when prescribing and in reimbursement is desirable. This shall enable tracking of multiple products contained in the transport packaging on a single serial number, and it shall be possible to direct these products in a single process.
MADDE 8- (1) SSCC (Serial Shipping Container Code): This is a transport unit identifier of which the standards were determined by GS1. Manufacturers/importers and pharmaceutical warehouses may also use SSCC (AI=00) in accordance with the rules laid down in the section “Identification of Transport Units” of the “Barcode Application Guidance” published by GS1, instead of GTINs and Serial Numbers, when barcoding of transport units in transport packages.
ARTICLE 9- (1) The general rules used in the placement of other Barcodes shall apply also in the placement of the Barcodes of Medicinal Products for Human Use. Hence;
- Where possible, the barcode and data matrix should be on different planes; where not possible, there should be a distance of 1 cm. between the barcode and the data matrix. The human readable information relating to the data matrix may be included into this area.
- The position of the barcode and data matrix on the product package should facilitate the legibility of the barcode and data matrix. The GS1 System recommends similar positions on the product packages for barcodes and data matrices whose form and size are similar.
- The barcode should be on a flat (even) surface.
- The barcode should not be placed on parts where the package is folded/joined.
- The barcode and the data matrix should not be positioned in a point of the package where they may get creased, the section where the barcode and the data matrix are printed should not get creased and folded.
- The barcode and the data matrix should not be covered with any object or shape.
ARTICLE 10- (1) The company owning the product shall be responsible for the smooth reading by the automatic data collectors (barcode readers) for the composition of the barcodes to be placed on Medical Products for Human Use.
(2) When designating the quality principles of the barcodes and data matrices to be composed, the following standards shall be taken as basis in relation with barcode verification:
a) For Linear Barcodes (EAN-13, GS1-128): TS EN ISO/IEC 15416 Information Technology – Automatic identification and data capture techniques – Barcode printing quality trial property; Linear symbols;
ARTICLE 11- (1) The content of the barcodes to be placed on Medicinal Products for Human Use shall be printed in a human readable or legible manner below the barcode in linear barcodes and adjacent to the data matrix in data matrices.
(2) The application identifiers shall be specified in parentheses for the purpose of facilitating the reading. However, these parentheses shall not be included into content of the data matrix.
In the human readable information of the data matrixed label seen in the example, the parentheses indicating the application identifiers are for demonstrative purposes and shall not be included into the data matrix content.
(3) The human readable information are described to meaningfully and collectively demonstrate the data matrix contents. In some small packages, because there is a problem with respect to available space, the expiration date and batch number may not be included in the human readable information, provided that they are indicated on other parts of the package. However, the GTIN and Serial Number should be on a place compatible with the data matrix and should be apprehensible.
ARTICLE 12- (1) There are no restrictions relating to the printing of the barcode and data matrix on the package. Registration/permit holders shall be free in performing the application with the most suitable method for them. However, in the data matrix applications to be performed with the label method on the outer package of the product, it should be ensured that the labels are destroyed if they are removed or the removal of the adhesive part of the label is prevented. This scope shall also apply for cases where data matrix is applied upon modifying the labels prepared previously.
(2) For all barcode applications, the degree of the printing quality shall be by minimum at “D” grade. In serial production lines, it shall suffice to conduct product testing through sampling to ensure the same grade.
MADDE 13- (1)An internationally recognized coding system is adopted for unifying fields of activity under a code system. The Global Location Number established by the GS1 organization shall be used to encode locations.
(2) Creating and using the Global Location Numbers shall be in accordance with the rules of GS1 Organization. For more information on GLN, refer to the “GLN Allocation Rules” document issued by the GS1 system.
(3) The Global Location Number shall be affixed on documents, where appropriate, using a bar code in the EAN13 bar code standard.



A product label sample with standard-compliant data matrix:
This figure shows a product label with standard-compliant data matrix.
These paranthesis are using to make easy of human reading.
Please be careful to use GTIN’s AI as (01) and “0” at the beginning of GTIN.
A product label sample with standard-compliant data matrix: In this figure, a user who wanted to write the code in one go using a smaller space used a rectangle data matrix and indicated the GTIN and Serial Number next to it. It is recommended that the rectangle form of data matrix be used on the packages which have inclined surfaces. In this sample, it should be noted that the data matrix contains all of the 4 required information and the expiration date and batch no are indicated on somewhere else on the package.
A product label sample with a three-line data matrix:This figure shows a sample for the cases in which the batch number is not included in the human readable codes as it is indicated somewhere else on the package.
In this example, the batch number isn’t indicated in the human readable codes, but the data matrix includes all of the 4 fields.
A data matrix label sample with non-standard information:
In this figure, it is shown that information other than the standard fields included in human readable information may be written. This information applies in the cases where the expiration date and batch no are not indicated in a second place on the package. Such applications may be used provided that the information is written as close as possible to the standard. This information should be of an explanatory nature for the human readable information, they may not contain different information Bu.
(Use of red color is for demonstrating the difference, it is not mandatory to use different colors.)