Technical guide 1. june 2011

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1 Technical guide 1. june 2011 Bar code labelling on primary and secondary packages for pharmaceutical products patient safety Preface This technical guide is designed to help companies put bar code labels on primary and secondary packages. Definition of primary package and secondary package The primary package (inner package) contains the pharmaceutical product and is in direct contact with the pharmaceutical product. An example is a bottle of pills containing 100 pills. If the primary package is also the secondary package (e.g. a bottle of pills not contained in a box), the requirements for a bar code symbol on a secondary package must be complied with. A secondary package (outer package) is a sales unit which can contain one or more primary packages. A secondary package can for example be a box containing one or more tubes, bottles of pills, blister packs or similar products. Allocation of product number for the primary package A primary package, which is not also a secondary package, is not a sales unit in Denmark, and therefore will not be assigned an item number (Vnr) from the Dansk Lægemiddel Information A/S or will not have a marketing license. The primary package only needs a "product number" as the identification key (GTIN) in a bar code symbol for the purpose of identification by medical staff via a barcode reader. The manufacturer has the option - if there is a one-to-one relationship between primary and secondary package (one secondary package containing only one primary package) - to use the same identification key in the bar code symbol of the primary package as in the bar code symbol of the secondary package. Manufacturers also have the option to allocate a different identification key for the primary package than for the secondary package, if desired, see figure 1. Figure 1 GTIN on primary package If a manufacturer wants to put another identification key on the primary package than exists on the secondary package, the manufacturer must use a new GTIN (Global trade item number). A GTIN is acquired through membership of GS1 Denmark or another GS1 member organisation. The manufacturer should, first of all, find out whether they are already members of GS1 Denmark or another GS1 member organisation. Allocation of item number for secondary package A secondary package is a sales unit in Denmark, and must have an item number (Vnr). The holder of a marketing license or his representative may request an item number (Vnr) to a pharmaceutical product when the pharmaceutical product has a marketing license. Vnr can be ordered from the Dansk Lægemiddel Information A/S (DLI), which manages the system. An assigned Vnr must only be used for one marketing license. The manufacturer can use a bar code symbol starting with the Nordic item number prefix "704626" if desired, but may also assign their own GTIN (unique identification key), if desired. Version 2 17/

2 Vnr, GTIN and bar code symbol The technical coherence between the different terms is as follows: Vnr can be part of a global unique identification number (GTIN), which is put into a bar code symbol, such as an EAN-13 or GS1 DataMatrix, see figure 2. Figure 2 technical coherence between Vnr, GTIN and bar code symbol Note that a primary package must retain the same GTIN even though there are different quantities of primary packages within secondary packages, see figure 3. Figure 3 Allocating GTIN Pack Level indicator A uniform grouping of trade items is a standard and stable grouping of identical trade items. The manufacturer or supplier has the option of either assigning a unique GTIN-13 to each grouping or assigning a unique GTIN-14. These 14-digit GTINs incorporate the GTIN of the trade item (less its Check Digit) Version 2 17/

3 contained in each grouping. The Check Digit for each GTIN-14 is then recalculated. The Indicators have no meaning. The digits do not have to be used in sequential order, and some may not be used at all. The Indicator is a digit with a value of 1 to 8. It is assigned as required by the company that constructs the identification number. GTIN-14 can be used to identify primary package level. See figure 4 below. Figure 4 usage of pack level indicator Notice that the Check Digit changes for each indicator as shown below Indicator GTIN of Trade Item Contained in the Grouping, Less Its Check Digit New Check Digit Description Quantity Secondary package A box with X Primary package Single Standard trade item grouping A grouping Indicators 1 to 8 may be used to create new GTIN-14s. (Indicator digit 9 is reserved for Variable Measure Trade Items). Bar code symbol content and Data Carrier (bar code symbology) type EAN-13 contains only a 13 digit item number. The GS1 DataMatrix bar code symbol by definition is the ISO/IEC standard ECC 200 Data Matrix with a Function One (FNC1) character in the first data position which indicates the data that follows is a GS1 data format. The GS1-128 standard describes the data formats the different types of information contained in the barcode must comply with. The GS1-128 data format for GTIN is the following Application Identifier (01) digits (GTIN). Version 2 17/

4 Example: The parentheses must not be a part of the data encoded in the bar code symbol. The parentheses are only a part of the human readable information. It is recommended that the GTIN is expressed in human readable interpretation if there is enough space. The human readable information must appear clearly and easy to read. There are no requirements for specific text font or text size. The human readable interpretation may be printed anywhere in the area surrounding the symbol as long as the Quiet Zones are respected. Notice that national labelling legislation requirements must be respected at all times. Bar code symbol dimensions EAN-13 An EAN-13 bar code symbol, which measures 6 X 19 mm. (analogous to the bar code symbol on SAD ampoule label) can be scanned by the hospitals scanners. The EAN-13 bar code symbol must not be smaller than 6 X 19 mm. 6 mm 19 mm It is important for the scanning process that there is a margin on both sides of the barcode called a quiet zone, which contains no text or other information. The size of the quiet zone depends on the dimensions of the barcode. Version 2 17/

5 GS1 DataMatrix A GS1 DataMatrix can have two symbol forms square and rectangle. Which form fits best depends on size and shape of the product type, amount of data to encode, the printing process etc. The minimum module dimension for GS1 DataMatrix bar code symbols in this application is an X dimension of mm, where the X dimension refers to height and width of a single module (dot/square) in a GS1 DataMatrix. Maximum X dimension in this application is mm. The dimension of the quiet zone for a GS1 DataMatrix is 1X on all four sides. Example: If the module size of mm is used the practical minimum dimensions of a GS1 DataMatrix in square form containing (01) is 4.08 mm. X 4.08 mm for rectangle form same content it is 2.55 mm X 8.67 mm. 4.08mm 2.55 mm 4.08mm 8.67 mm General placement rules It is recommended that the bar code symbol is placed on a plain surface and never around a corner, on a rim, at a welding seam or the like. It is recommended that EAN-13 bar code symbols are placed vertically if the product is round with a diameter less that 6 cm. For GS1 DataMatrix, it is necessary that the scanner can take a picture of the whole bar code. To increase readability, it is recommended to place the GS1 DataMatrix on a plain surface (e.g. top or bottom of the product), so that the bar code does not get nonuniformity, i.e. is not changed in shape or size (as shown below). Bar code on sealed primary package If the product is sealed, the bar code must be placed on the sealed material and/or on the product itself. For products that are packed in light protection material, the bar code must be placed on the light protection material and not the product itself. Version 2 17/

6 Bar code Symbol Quality Bar code symbols must be scanable at a satisfying level of performance through the expected life span of the product and through the whole supply chain. ISO/IEC is the standard for how to measure the quality of a GS1 DataMatrix barcode. ISO/IEC is the standard for how to measure the quality of an EAN-13 barcode. ISO/IEC and ISO/IEC use a reporting system that expresses a symbol grade that includes the overall symbol grade as a number or letter, an indication of the wavelength of the light used for the measurement, a number corresponding to the measuring aperture and specifically for testing of 2D bar code symbols an indication of the angle of illumination during the test. A typical symbol grade could look like 2,7/05/660 or B/05/660 for 1D/linear bar code symbols or 2,8/10/660/30 or B/10/660/30 for 2D/matrix bar code symbols. Generally grades of A or 4.o are considered op marks. According to the GS1 General Specification 1 both EAN-13 and GS1 DataMatrix must at least have an overall symbol grade of 1.5/06/670 (C/06/670) doe 1D or 1.5/8/670/45 (C/8/670/45) for 2D. The manufacturers who apply bar code symbols are responsible for making sure that the symbols meet the quality requirements. Different types of equipment for testing the print quality of the bar code symbols are available, and it is important that the equipment also complies with all applicable standards, (e.g. GS1 General Specification, ISO/IEC 15415, ISO/IEC 15416, ISO/IEC all parts). Testing of the readability of a bar code symbol before final labelling is recommended. Colour & background It is recommended that the lines/dots/squares of the barcode are black on a white background to maintain maximum contrast needed for scanning. If that is not possible it is recommended that the lines/dots/squares of the barcode are dark on a light background. Barcode printing & environment If a barcode label is used it is important to choose a barcode label and use glue that suits the environment (e.g. cold, hot and room temperature) so the barcode is always scanable and the label will not fall off. If a barcode is printed directly on the product it is important to use ink that suits the environment (e.g. cold, hot and room temperature) so the barcode always is scanable. Information about primary package identification to trading partners A GTIN on the primary package must be linked to the product information on the secondary package. In the hospital sector, this is done by Amgros receiving the necessary information from the manufacturer or the marketing license holder and making this information available in a pharmaceutical database. The database is made accessible for hospital trading partners. Information about secondary package identification to trading partners The secondary package, which is the sales unit, has a GTIN and a Vnr (which can be part of GTIN). All related product information is linked to the Vnr and is communicated through Medicinpriser.dk. The database is accessible to hospital trading partners. Amgros communication of product information to the public hospitals Today, Amgros communicates product information as from Medicinpriser.dk, to the hospitals and as an extension to this, information about GTINs on primary packages will be available from 2011 where this type of information is required. ApoVision, which is the system behind the hospitals dose dispensing, EHR / EPM, etc., will also redistribute GTIN information on primary package for use in wards, clinics and service production and where safe pharmaceutical identification otherwise should take place. For further information about barcodes: Amgros tender requirements comply with the global GS1 General Specification. However, please note that: 1 GS1 General Specification: Global sector-independent standards for optimizing supply chain processes, including standards for the use of barcodes. Version 2 17/

7 Amgros allows barcode dimensions of 6 X 19 mm. for the EAN-13 barcode, which is a lower height than the GS1 General Specification recommendation. It is recommended that the GTIN is expressed in human readable information if there is enough space. There have to be human readable information to be compliant with the GS1 General Specification recommendation. The manufacturer has the option - if there is a one-to-one relationship between primary and secondary package (one secondary package containing only one primary package) - to use the same identification key in the bar code symbol of the primary package as in the bar code symbol of the secondary package. That is not compliant with the GS1 General Specification recommendation. If you do not have a bar code symbol on primary package today it is recommended to put a new identification key on the primary package instead of using the bar code symbol from the secondary package. For further information about technical aspects of the recommended GS1 Data Carriers noted: Reference o GS1 General Specification Contact GS1 Denmark as noted below o GS1 DataMatrix An introduction and technical overview of the most advanced GS1 Application Identifiers compliant symbology : nical_overview.pdf o ISO/IEC Information technology Automatic identification and data capture techniques Bar code print quality test specification Two-dimensional symbols o ISO/IEC Information technology Automatic identification and data capture o techniques Bar code print quality test specification Linear symbols o ISO/IEC Information technology Automatic identification and data capture techniques Bar code verifier conformance specifications Part 1: Linear symbols / Part 2: Two-dimensional symbols Contact for assistance: o GS1 Denmark Phone: Version 2 17/

8 Appendix A - GTIN-13 calculation The check digit is calculated on basis of the first 12 digits. A: Each digit in the GTIN-13 is multiplied with 1 respectively 3. Always start backwards with 3, 1, 3, 1 and so forth. B: The results of the calculations are written directly underneath x1, x3, x1 and so forth. The results are added to one final sum. C: The final result from B is rounded up to the nearest whole tens. D: The result from B is deducted from the result from C. This gives the check digit K. Example: GTIN (A) x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 x1 x3 (B) =70 (C) 70 is rounded up to the first whole tens: 70 (D) Check digit: = 0 GTIN-13: Version 2 17/

9 Appendix B Application Identifiers (AI s) Data in a GS1 DataMatrix bar code must comply to the GS1-128 data structure. GS1-128 structure describes which data formats the different information must have. The GS1-128 structure must always start with a FNC1 character. The FNC1 character means that the data in the bar code is compliant to the GS1-128 structure. The GS1-128 structure can contain many different information. The most used information in healthcare is GTIN, batch, expiry date, serial number and date and time of production. Information are expressed through Application Identifiers (AI) and after that the data. An Application Identifier is a number of 2-4 digits, which shows the software behind the barcode scanner the meaning and format of the digits shown after the AI. The GS1-128 data formats for GTIN, batch number, expiry date, serial number, and date and time of production are the following: Application Identifier Information Data format 01 GTIN n2+n14 10 Batch number n2+an expiry date - YYMMDD n2+n6 21 Serial number n2+an Date and time of production - YYMMDDHHMMSS n4+n12 n2 tell how many digits there must be in the parenthesis, and n14 tell how many digits there must be after the parenthesis. an..20 means the batch can be both letters and numbers and up to 20 digits. Example for GS1-128 data format: GTIN: Exp. date: Batch number: BV1234 (01) (17)100901(10)BV1234 Application Identifier 01 GTIN (Global Trade Item Number): Application Identifier 01 is used for identification of a product with a GTIN - Global Trade Item number: GTIN- 14, GTIN-13 or GTIN-12. By identification with a GTIN-13 and a GTIN-12 a "0" is placed respectively one or two times in front of the item number, so all the 14 fields in the data format is filled. In the healthcare sector there will in most cases be a GTIN with 13 digits (GTIN-13) on both primary and secondary packages, which mean that there should be inserted a zero in front of the GTIN when it is specified in GS1-128 structure. You can also choose to assign a GTIN-13 to the primary package and a GTIN-14 to the secondary package. GTIN-14 contains GTIN-13 on the primary package and an indicator of package level. The first digit indicates the package level and can have a value of 1-8. Version 2 17/

10 There are two ways that you can assign the GTIN: 1) Assign a unique GTIN-13 for the primary and the secondary package. Example: to primary package and to secondary package. 2) Assigning a unique GTIN-13 for the primary package and a GTIN-14 for secondary package. Example: to primary package and to secondary package. GTIN is used as a key to retrieve product master data in databases. Example: (01) for GTIN-13. Application Identifier 10 batch number: Application Identifier 10 is used to indicate a batch number on a product. A batch number can include different information, for example: A number on a production line, time of production and a number on a mixture. Batch number can be used to track and trace pharmaceuticals. Example: (10) BV1234 Application Identifier - 17 Expiry date: Application Identifier 17 indicates the date, which the product expires. The structure of the date is: year, year, month, month, day, day. Example: (17) September 2010 Example: (17) January 2010 Application Identifier - 21 serial number: Application Identifier 21 is used to indicate the primary serial number. The serial number is a unique number, which is allocated to the product and it is used in the entire lifetime of the product. The serial number must be unique for a specific product, which means that same serial number can be allocated to several products. But together with the unique GTIN the serial number will give a unique identification of the individual product. Example: (21) VB Application Identifier Date and time of production: Application Identifier 8008 is used to indicate date and time of production. Date and time of production is defined by the producer and can refer to the trade item it selves or the product contained. The structure of date and time of production is: year / year / month / month / day / day / hour / hour / minute / minute / second/ second. Example: (8008) th February 2011 time Version 2 17/

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