Saudi Drug Code (SDC), and Drug Barcoding Specifications

Drug SectorLicensing Executive DirectorateGuidance for IndustrySaudi Drug Code (SDC), andDrug Barcoding SpecificationsThis document outlines the new proposed barcode requirements for pharmaceuticals. Is is a draftcopy for comments.Version 0.2Please send your comments to sdr.drug@sfda.gov.sa

Document ControlVersion Date Author Comments0.1 12/12/12Business Support and Archiving Unit.Licensing Executive Directorate0.2 07/01/13 Business Support and Archiving Unit.Licensing Executive DirectorateFirst DraftPublished for comments2 | P a g e

Table of ContentsI. Introduction ........................................................................................................................ 4II. Objectives ........................................................................................................................... 4III. Requirements .................................................................................................................. 41. Carrier ............................................................................................................................. 42. Data................................................................................................................................. 53. Print ................................................................................................................................ 54. Serial Number .................................................................................................................. 55. GLN: ................................................................................................................................ 6IV. Saudi Drug Code .............................................................................................................. 6V. Databases: ........................................................................................................................... 7VI. What Industry has to do? ................................................................................................. 7VII. Benefits ........................................................................................................................... 8a) To the Industry ................................................................................................................ 8b) To distributors and wholesalers: ...................................................................................... 8c) To retail pharmacies ........................................................................................................ 9d) To Hospitals: .................................................................................................................... 9VIII. Appendix A: GS1 Data Matrix (2D) Barcode .................................................................... 10a) Definition ...................................................................................................................... 10b) Printing Location............................................................................................................ 10c) Printing Instructions ...................................................................................................... 10d) Readers ......................................................................................................................... 10IX. Appendix B: Global Trade Item Number (GTIN) .............................................................. 11a) Definition ...................................................................................................................... 11b) GTIN-14 ......................................................................................................................... 11c) Why GTIN ...................................................................................................................... 11X. Appendix C: Global Location Number (GLN)....................................................................... 12a) Definition ...................................................................................................................... 12b) Why GLN?...................................................................................................................... 123 | P a g e

XI. References..................................................................................................................... 13I. IntroductionUnified standards for automatic identification in the healthcarefield provide an opportunity to make the drug supply chain in SaudiArabia, safer and yet more efficient and accurate. The Drug Sector inSaudi Food and Drug Authority (SFDA) believes that a standardizedidentification system from the manufacture to the patient is imperativeto comply with the increasing need for product integrity and traceability.Therefore, and since the Global Standards (GS1) system, globallyendorsed by the healthcare community, is one of the most widely usedtrade item identification systems worldwide (GS1, 2011), the DrugSector is urging all drug manufacturers in Saudi Arabia and internationalmanufacturers exporting to Saudi Arabia, to adopt GS1 supply-chainstandards. This document outlines the new requirements, benefits, andthe current and future objectives of this projects.II.Objectives Increase patient safety and reduce medication errors. Traceability and fast product recalls or withdrawals. Counterfeit detection. Real-time and accurate information flow between stakeholders.III.Requirements1. CarrierAll drugs’ marking must be upgraded from linear barcodes (Figure A)to GS1 Data Matrix Barcode (Figure B).4 | P a g e

(Figure A) Linear Barcode(Figure B) GS1 Data Matrix2. DataThe Data Matrix barcode shall carry the following data:3. Print GTIN-14 : GS1 Global Trade Identification Number (productidentification code). Expiry Date in DDMMYY format (Attribute). Batch/Lot Number (Attribute).The following data must be printed on the drug secondary package justbeside or below the Data Matrix barcode:4. Serial NumberGTIN: 00000000000011EXPIRY: YYYY-MM-DDBATCH/LOT: ABCD1234Marking each drug package with a unique serial number will berequired by SFDA in the future in order to support the drug track andtrace process. This number will be required to be printed along with theother attributes and encoded within the Data Matrix barcode. There willbe further support documentation published by SFDA to illustrate itsspecifications.5 | P a g e

IV.5. GLN:All pharmaceutical manufacturers must acquire a Global LocationNumber (GLN) from GS1 for their manufacturing sites. This number willbe required by SFDA’s drug systems in order to uniquely identify everyphysical location.Saudi Drug CodeSaudi Drug Code (SDC) is a new registration code that is going tobe given by the Drug Sector to each registered drug in the Saudi market.This new code shall eventually replace the current drug registrationnumber (example: A) which is normally granted with the approval of thedrug registration.Example: a12-111-07The SDC will contain fewer variables than its predecessor. Therefore, itwill be more stable and reflecting the application type in addition to theyear of registration. The following illustrate the structure of SDC:Drug –Health or Herbal- Vet - ListedFixed PrefixSFDA 99 D 122SFDA 12 H 064SFDA 03 V 012SFDA 12 L 001Serial NumberYear6 | P a g e

Here are some examples of the final SNDC format:V. Databases:SFDA12D001SFDA13H011SFDA14V111The Drug Sector will start gradually to collect all registered drug’s GTIN-13 numbers in order to add them to the database that is currently beingpublished periodically on the SFDA’s website. Each registered item in thedatabase is going to carry a GTIN-13 and a SDC as in the followingexample:VI.What Industry has to do?1. Contact the GS1 office for more information about acquiring GTIN,GLN, and Data Matrix barcodes.2. Prepare the production lines for printing and verifying the newbarcodes.3. Plan to be logistically ready for serializing all products in the future.NoteAll stakeholders’ supply chain databases have to be constructed in away that they accept 14-digit Global Trade Item Numbers. However,SFDA database will provide GTIN-13 numbers for each item (lackingthe front digit that is assigned for the packaging level).7 | P a g e

VII.Benefitsa) To Manufacturers Reduce inventory assets: Improve demand forecastingand inventory planning. Reduce inventory financing and holding cost:o Reduce financing due to lower inventory assets.o Reduce inventory management cost with more efficient andaccurate processes. Reduce produce waste due to obsolescence: Improve inventorymanagement to shrink inventory levels and unused product. Reduce cost of recalls:o More efficient execution (increased supply chain visibility).o Reduce scope of recalls (better targeting). Reduction in counterfits and recovery lost profit: Reduction incounterfit supply raises sales volume. Brand Protection. To support track and trace of products. Errors reduction. To support patient and product safety. To obtain hospitals accreditation.b) To distributors and wholesalers Reduce inventory assets: Improve demand forecasting and inventoryplanning. Reduce inventory financing and holding cost:o Reduce working capital requirements by lowering inventoryassets.o Reduce inventory management cost with more efficient andaccurate processes. Recall effectiveness: distributors capture shipment lot numbers forpotential recall processing8 | P a g e

VIII.Appendix A: GS1 Data Matrix (2D) Barcodea) DefinitionIt is a graphic representation of any digital data in a 2-dimensional format,with high decoding information capacity that can be read by opticalequipment. It provides: High storage capacity: Encoding and marking of a greater amount ofdata within a smaller space. Direct marking: On items where labels may not be practical. Image Readable. Auto-correction: Error detection and correction capabilities to improvethe readability of bar codes despite irregular packaging or physicaldamage to a label.b) Printing LocationThe Data Matrix barcode must be printed on one of the sides of the secondarypackaging. It must be placed preferably on a flat surface. To facilitate thereading process, it must be placed on the same side where possible.c) Printing Instructions› Ensure that the surface to be marked is suitable for printing.› Verify through testing that rubbing does not damage the marking,› Testing the legibility of barcode marking in certain moist conditions.› Using the same printing quality for information redundancy.d) ReadersTo read the Data Matrix barcode, camera-based bar code scanners arerequired. Laser bar code scanners cannot read data matrix bar codes.However, camera-based bar code scanners can read both linear and all 2-Dbar codes such as Data Matrix. Generally, camera-based scanners have ahigher price point than laser scanners, but they offer distinct advantages, suchas:10 | P a g e

› Flexibility: they can read both 2D and linear bar codes versus laserscanners which can only read linear bar codes.› Reliability: It has less moving parts than laser based scanners. Therefore,lower total cost of ownership.› It support image capture: allowing imaging of a product or anidentification card, or even a document up to 21.6 x 28 cm (8”x11”).› Compact: allow easier integration with other systems (e.g. packaging lineverification) or in a handheld computer.IX.Appendix B: Global Trade Item Number (GTIN)a) DefinitionThe GS1 Global Trade Item Number (GTIN) is an identification key thatuniquely identifies products worldwide. It can be encoded into various typesof data carriers such as Data Matrix.b) GTIN-14GTIN’s are available in several lengths. GTIN-14 is the required form and it iscomposed of 14 digits:› One digit representing the Indicator digit to indicate packaging level.› Twelve digits the GS1 Company Prefix and the Item Reference assigned byyour company.› One digit representing the Check Digit.c) Why GTIN It facilitates the global flow of trade products and associated informationused in electronic commerce. Uniquely identifies trade products at all levels of packaging (item, case, andpallet). Allows accurate machine reading of trade products when placed in barcodes. Delivers trade products data in a consistent format and structure. Simplifies supply chain management.11 | P a g e

X. Appendix C: Global Location Number (GLN)a) DefinitionThe Global Location Number (GLN) is a globally unique GS1 IdentificationNumber that is used to identify any location in the supply chain that needs tobe uniquely identified.b) Why GLN?GLN is very important to help in the location identification process. Itlinks to the organization’s name, address, and type in the databases, reducingeffort to maintain and communicate this information between all parties. Thisincreases the efficiency, accuracy and precision of sharing locationinformation, crucial to logistical operations. It is also substantial to achievetraceability in healthcare and improve supply chain efficiency and visibility.12 | P a g e

XI.References• McKinsey report: "Strength in unity: The promise of global standards inhealthcare"http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf• 10 Steps to BarCodes Implementationhttp://www.gs1.org/barcodes/implementation• GLN Allocation Ruleshttp://www.gs1.org/1/glnrules/• GS1 DataMatrix :An introduction and technical overview of the mostadvanced GS1 Application Identifiers compliant symbology.http://www.gs1.org/docs/barcodes/GS1_DataMatrix_Introduction_and_technical_overview.pdf• GLN in Healthcare-Implementation Guidehttp://www.gs1.org/docs/gsmp/healthcare/GLN_Healthcare_Imp_Guide.pdf• GS1 Saudi Arabiahttp://www.gs1.org/countries/saudi%20arabia• GS1 Healthcare Position Statement on GS1 DataMatrix Implementationhttp://www.gs1.org/docs/healthcare/GS1_Data_Matrix_Position_Paper.pdf13 | P a g e