Lecture 1: Introduction to UML: Structural Modeling and Use Cases! ... that share the same attributes, ... aggregation A special form of association that
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GS1 Healthcare GTIN Allocation Rules,Document Summary. Document Item Current Value, Document Name GS1 Healthcare GTIN Allocation Rules. Document Date Dec 2015,Document Version 9 0,Document Issue 2. Document Status Ratified, Document Description GTIN Allocation Rules for the Healthcare Sector. Contributors,Name Organisation,Log of Changes, Release Date of Change Changed By Summary of Change. 9 0 1 July 2015 Valerie Hoste Applied new GS1 branding and errata fix to add. figure heading 5 11 example of a medical, 9 0 2 Dec 2015 David Buckley Errata fix wrong cross references in section. 5 1 8 and fixed corrupted figure cross references,Disclaimer. GS1 under its IP Policy seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in. the Work Group that developed this GS1 Healthcare GTIN Allocation Rules to agree to grant to GS1 members a. royalty free licence or a RAND licence to Necessary Claims as that term is defined in the GS1 IP Policy Furthermore. attention is drawn to the possibility that an implementation of one or more features of this Specification may be the subject. of a patent or other intellectual property right that does not involve a Necessary Claim Any such patent or other. intellectual property right is not subject to the licencing obligations of GS1 Moreover the agreement to grant licences. provided under the GS1 IP Policy does not include IP rights and any claims of third parties who were not participants in the. Work Group, Accordingly GS1 recommends that any organisation developing an implementation designed to be in conformance with this. Specification should determine whether there are any patents that may encompass a specific implementation that the. organisation is developing in compliance with the Specification and whether a licence under a patent or other intellectual. property right is needed Such a determination of a need for licencing should be made in view of the details of the specific. system designed by the organisation in consultation with their own patent counsel. THIS DOCUMENT IS PROVIDED AS IS WITH NO WARRANTIES WHATSOEVER INCLUDING ANY WARRANTY OF. MERCHANTABILITY NONINFRINGMENT FITNESS FOR PARTICULAR PURPOSE OR ANY WARRANTY OTHER WISE ARISING. OUT OF THIS SPECIFICATION GS1 disclaims all liability for any damages arising from use or misuse of this Standard. whether special indirect consequential or compensatory damages and including liability for infringement of any. intellectual property rights relating to use of information in or reliance upon this document. GS1 retains the right to make changes to this document at any time without notice GS1 makes no warranty for the use of. this document and assumes no responsibility for any errors which may appear in the document nor does it make a. commitment to update the information contained herein. GS1 and the GS1 logo are registered trademarks of GS1 AISBL. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 2 of 26. GS1 Healthcare GTIN Allocation Rules,Table of Contents. 1 Scope and background 5, 2 Introduction to Global Trade Item Number in healthcare 5. 2 1 Definition of a GTIN 5,2 1 1 GTINs in healthcare 5. 2 1 2 Structure of a GTIN 6,2 2 Healthcare items definitions 7. 2 2 1 General definitions 7,2 2 2 Pharmaceutical products 7. 2 2 3 Medical devices 8,2 3 Data requirements in healthcare 8. 2 3 1 Global Trade Item Number GTIN 8,2 3 2 Serial Number 9. 3 Regulators 9,4 Allocating the Numbers 9,4 1 General Rule 9. 4 1 1 Differentiation between primary package and secondary packages in a one to one 1 1. relationship 10,4 2 Responsibility 10,4 2 1 Branded items 10. 4 2 2 Kitter 10, 4 3 Guidelines for Allocating Global Trade Item Numbers 10. 4 3 1 Pre defined characteristics 10,4 3 2 Lead time in re using a GTIN 11. 4 3 3 Prepriced merchandise 11,4 3 4 Trade item changes 11. 4 4 Identification within a hierarchy 11,4 5 Takeovers 13. 4 5 1 Acquisitions and mergers 13,4 5 2 Partial purchase 13. 4 5 3 Split or spin off 13,4 6 Data alignment 14,4 6 1 Data alignment best practice 14. 5 GTIN Allocation scenarios 14,5 1 General Rules 14. 5 1 1 Different language or target market 14, 5 1 2 Additional language on the packaging sold in several markets 14. 5 1 3 Changes in packaging materials or minor artwork changes 15. 5 1 4 Promotions 15,5 1 5 Declared change in net content 16. 5 1 6 Groupings of same item containing different quantities 16. 5 1 7 New additional pallet layouts that co exist permanently with the original layout 17. 5 1 8 Kits 17, 5 2 Regulated pharmaceuticals Prescription and non prescription 19. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 3 of 26. GS1 Healthcare GTIN Allocation Rules,5 2 1 General rules 19. 5 2 2 Rules for single unit 19, 5 2 3 Single unpackaged pills tablets capsules caplets and those packaged in blister cells 19. 5 3 Medical devices 20,5 3 1 General rules for medical devices 20. 5 3 2 Configurable medical devices 21,5 3 3 Medical device software 21. 5 3 4 Inclusion of a Certification Mark 22,5 3 5 Barrier packs Sterile packaging 22. 5 3 6 Rules for single Unit 23,A Glossary of terms 25. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 4 of 26. GS1 Healthcare GTIN Allocation Rules,1 Scope and background. Unique identification provides an opportunity to differentiate in a machine readable form an item s. identification Such information is rapidly becoming a pre requisite when linked with the item s. batch number or unique serial number and expiration date for traceability of all healthcare. products from production to delivery to the patient point of care This voluntary guideline was. developed by the GS1 Healthcare so that when and where product identification is required there. will be consistency in the use of data structures worldwide It also covers the specific Point of Sale. requirements which are essential for Prescription Non Prescription healthcare items. GS1 Healthcare is developing promoting and implementing global industry standards for solutions. to prevent medical errors combat counterfeit products and improve supply chain efficiencies. throughout the healthcare industry The initial focus has primarily been on Pharmaceutical and. Medical Devices and thus this document reflects the current engaged representation While the. principles and examples given may be applied to the entire healthcare sector further development. and updates to ensure that specific examples from animal health dental products etc may be. added Should a sector believe it is necessary to provide further input or additions to this document. it should approach GS1 Healthcare to initiate these discussions. Note The GS1 Healthcare website http www gs1 org healthcare is continuously updated. Note Terms specific to this document are defined in the Glossary of Terms Appendix A. additional terms are found within the GS1 General Specification. 2 Introduction to Global Trade Item Number in healthcare. 2 1 Definition of a GTIN, The Global Trade Item Number GTIN is used for the unique identification of trade items. worldwide GTINs may be 8 12 13 or 14 digits in length Their data structures require up to 14. digit fields and all GTIN processing software should allow for 14 digits. A trade item is any item product or service upon which there is a need to retrieve pre defined. information and that may be priced or ordered or invoiced at any point in any supply chain This. includes individual items as well as all their different configurations in different types of packaging. 2 1 1 GTINs in healthcare, Global Trade Item Numbers GTINs uniquely identify items that are traded Pharmaceuticals. Medical Devices etc in the Supply Chain Integrity of these numbers throughout the item s lifetime. is a key to maintaining uniqueness for manufacturers wholesalers distributors hospitals. regulatory bodies and other Supply Chain stakeholders A change to one aspect characteristic. variant or formulation of a trade item may require the allocation of a new GTIN. Brand Owners who hold the specifications of a healthcare item must properly allocate and maintain. their GTINs to enable trading partners to distinguish products effectively for regulatory Supply. Chain and patient safety concerns, This publication is based upon the GS1 GTIN Allocation Rules www gs1 org gtinrules and has been. tailored to meet the specific needs of healthcare While all GS1 standards are voluntary the rules. are intended to drive consistent implementation in the Global Healthcare Community. Note National federal or local regulations may apply and will take precedence over this. voluntary guideline For example some healthcare regulators may place requirements or. restrictions on GTIN use within their jurisdiction. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 5 of 26. GS1 Healthcare GTIN Allocation Rules,2 1 2 Structure of a GTIN. Upon joining a GS1 Member Organisation companies receive a GS1 Company Prefix and full. documentation on how to allocate GTINs to their products The four methods to construct a GTIN. are explained in detail the web site http www gs1 org productssolutions idkeys. Although GTINs have an administrative structure to ensure that they are unique they should be. treated as non significant numbers This means that they should always be recorded and processed. in their entirety no part of the number relates to any classification or conveys any information. Note This GTIN format is used in business transactions especially for eCom e g electronic. orders invoices price catalogues etc, The figure below shows the construct of the GTIN 13. Figure 2 1 Example of a GTIN 13,GS1 Company Prefix Item Reference Check. N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13,GS1 Company Prefix. The GS1 Company Prefix consists of a GS1 Prefix and the Company Number both of which are. allocated by GS1 Member Organisations In general it comprises six to ten digits depending on. the capacity needs of the company, The first two or three digits N1 N2 N3 constitute the GS1 Prefix allocated by GS1 Global Office to. each GS1 Member Organisation It does not mean that the item is produced or distributed in the. country to which the prefix has been allocated,Item Reference. The Item Reference is a component of the Global Trade Item Number GTIN assigned by the. owner of the GS1 Company Prefix or U P C Company Prefix to create a unique GTIN and is a. non significant number which means that the individual digits in the number do not relate to. any classification or convey any specific information The simplest way to allocate Item. References is sequentially that is 000 001 002 003 etc. Check digit, The check digit is the last digit It is calculated from all other digits in the GTIN. Figure 2 2 Example of a GTIN 14, GTIN 14 Data Indicator GTIN of the items contained without check digit Check. Structure digit,N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14. The Indicator is only used in the GTIN 14 Data Structure It takes the value 1 to 8 see Note 1. below and is used for lower or higher packaging levels see section 4 4 Identification within a. hierarchy The simplest way to allocate the indicator is sequentially that is 1 2 3 to each. grouping of a trade unit, 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 or GTIN 12 to each. grouping or assigning a unique GTIN 14 with an Indicator value of 1 to 8 These 14 digit GTINs. incorporate the GTIN of the trade item less its check digit contained in each grouping The check. digit for each GTIN 14 is then recalculated, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 6 of 26. GS1 Healthcare GTIN Allocation Rules, 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 GTIN 14 structure for standard trade item groupings creates extra. numbering capacity Indicators can be re used, Note The value 9 is reserved for variable measure items These are rare in healthcare but an. example could be gases used in operations The amount of gas used for any given operation. is variable but can be priced or ordered or invoiced in predefined quantities e g cubic. metres when delivered to a hospital, 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 It can provide up to eight separate GTIN 14 Identification. Numbers to identify groupings of trade items, The 8 12 or a 13 digit GTIN of the trade items contained must always be the one of the relevant. levels of packaging contained usually the lowest level GTINs for restricted distribution must not be. used in this Element String,2 2 Healthcare items definitions. The legal definitions for healthcare items will differ from one country to another see section 3. Regulators Indeed some legal definitions for drugs are simply A substance recognised by an. official legal entity This section therefore aims to provide a global overview. 2 2 1 General definitions,2 2 1 1 Kits, Kits are collections of non homogeneous separable components that are identified purchased and. supplied as a single trade item for a specific clinical or commercial purpose. There are two primary types of kits, Finished product kit kits that are an assembly of only finished goods Components are trade. items where each component is a trade item identified by a GTIN Components do not need to. be individually packaged but are independently identified at the component packaging level. e g may be sellable identified and available for trade. Manufactured kit kits that are completed or finished in the kitting process At least one. component of a manufactured kit is not a finished trade item and therefore is not identified with. 2 2 2 Pharmaceutical products,2 2 2 1 Non prescription. A non prescription pharmaceutical product is a drug or medicinal specialty who s dispensing or. administration does not require medical authorisation Normally it can be used by the consumers. under their own initiative and responsibility to prevent relieve or to treat symptoms or mild. diseases Its use in the form conditions and authorised dosages should be safe for the consumer. This covers healthcare items that do not require a prescription or direct medical intervention Typical. examples include mouthwash low strength pain killers etc. 2 2 2 2 Prescription Rx, A Prescription often referred to as a Pharmaceutical Product Rx is a drug or medicinal specialty. that requires a prescription or direct medical intervention Typical examples include medicated. bandages pain medication injectables etc and can normally only be obtained with a prescription. from an appropriate health care practitioner, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 7 of 26. GS1 Healthcare GTIN Allocation Rules,2 2 2 3 Hospital pharmacy production. A Hospital Pharmacy Product is a product that has to be manufactured by a hospital pharmacy for. internal or multi hospital use thus it is not or is no more marketed by pharmaceutical company. that supplied the raw material These products may correspond to the Prescription or Non. Prescription category In any case they have to be clearly identified from the production to the. 2 2 3 Medical devices, Medical device means any instrument apparatus implement machine appliance implant in vitro. reagent or calibrator software material or other similar or related article intended by the. manufacturer to be used alone or in combination for human beings for one or more of the specific. purposes of, diagnosis prevention monitoring treatment or alleviation of disease. diagnosis monitoring treatment alleviation of or compensation for an injury. investigation replacement modification or support of the anatomy or of a physiological process. supporting or sustaining life,control of conception. disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens. derived from the human body and which does not achieve its primary intended action in or on. the human body by pharmacological immunological or metabolic means but which may be. assisted in its function by such means,2 2 3 1 Configurable devices. A configurable medical device is a product that consists of multiple components some of which may. be selected by the customer based on a list provided by the manufacturer The possible. configurations are determined by product design In all cases configurable medical devices are. considered to be and intended to be used as a single trade item and may be supplied through. multiple shipments,2 2 3 2 Medical device software. Medical Device Software as defined IEC 62304 Medical device software Software life cycle. processes is a software system that has been developed for the purpose of being incorporated into. the medical device being developed or that is intended for use as a medical device in its own right. Medical Device Software may be configurable where some features or modules can be selected by. the customer,2 3 Data requirements in healthcare,2 3 1 Global Trade Item Number GTIN. By joining a GS1 Member Organisation the company receives a GS1 Company Prefix which gives the. company the ability to create GTINs and access to the GS1 standards The GS1 System is designed. to be used in any industry or any part of the public sector so that an individual company can select. to allocate GTINs using a GS1 Company Prefix from the GS1 Member Organisation of their choice. However some Regulators impose mandatory local requirements on the use of GTIN within their. jurisdiction see 3 Regulators, Attributes e g Batch Number Expiration Date and Serial Number add value to the product as. production control attributes when combined with the GTIN in a GS1 barcode using the GS1. Application Identifiers Their use enables tracking tracing systems and can contribute to improving. patient safety For more information see the general guidelines http www gs1 org healthcare. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 8 of 26. GS1 Healthcare GTIN Allocation Rules, Within the GS1 System the following attributes may only be used in association with a GTIN. 2 3 1 1 Batch or Lot number, A Batch or Lot Number Application Identifier 10 associates an item with information the. responsible entity considers relevant for traceability of a trade item The number may be for. example a production lot number a shift number a machine number a time an internal. production code or a software version number The data is alphanumeric and length is variable up. to 20 alphanumeric characters,2 3 1 2 Expiration date. An Expiration Date Application Identifier 17 is often referred to as expiry date or maximum. durability date and indicates the limit of consumption or use of a product e g for pharmaceutical. products it will indicate the possibility of an indirect health risk resulting from the ineffectiveness of. the product after the date It is always encoded as a fixed length six numeric characters with the. structure YYMMDD where,YY the tens and units of the year e g 2015 15. MM the number of the month e g January 01, DD the number of the day of the relevant month e g second day 02. An Expiration Date and Time may also be expressed Application Identifier 7003 This structure is. only used when the exact expiration time is critical to patient safety. 2 3 2 Serial Number, A Serial Number Application Identifier 21 is typically used on medical devices that need to be. individually tracked and traced e g wheel chairs pacemakers MRI scanners. 3 Regulators, The healthcare industry is highly regulated and companies are required to comply with national. federal and or local regulations, This guideline has been developed as a global standard to help companies meet the key. requirement of Product Identification also an enabler for encoding batch and expiration date The. broader GS1 Global Healthcare User Group has a regulatory affairs area on the website see. http www gs1 org healthcare The GS1 Healthcare User Group advocates the use of global. standardisation to aid compliance to the regulatory requirements of all countries However it must. be stressed that national federal or local regulations may apply and take precedence over any GS1. 4 Allocating the Numbers,4 1 General Rule, A Global Trade Item Number GTIN is used to identify any item upon which there is a need to. retrieve pre defined information and that may be priced or ordered or invoiced at any point in. any Supply Chain Typically this includes the lowest level of packaging as well as higher packaging. A separate unique GTIN is required whenever any of the pre defined characteristics of an item are. different in any way that is relevant to the trading process This principle is demonstrated in the figure. below where the two products have identical ingredients and brand names but require separate GTINs. as one product can be sold anywhere while the other requires a Pharmacist to distribute because of. the intended usage, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 9 of 26. GS1 Healthcare GTIN Allocation Rules, Figure 4 1 Example of product change triggering a New GTIN be allocated. The guiding principle is if any significant change is made and it is expected to distinguish a new. trade item from an old trade item and use accordingly a new GTIN should be assigned This. document aims to define globally what is meant by significant change in healthcare by way of. practical examples, 4 1 1 Differentiation between primary package and secondary packages in a one to. one 1 1 relationship, Some healthcare processes require the capability to clearly differentiate between a healthcare trade. item in its primary and secondary packaging even if they share a one to one 1 1 relationship. An example could be a tube of cream in a box a vial in a box a single multiple quantity blister card. in a box or a syringe in a unit carton In this situation the trade item primary package and. secondary package may have different GTINs assigned when required by regulation or as agreed. within a trading partner relationship GTIN allocation and the marking of GTINs is made at the. discretion of the brand owner,4 2 Responsibility,4 2 1 Branded items. The Brand Owner the organisation that owns the specifications of the trade item regardless of. where and by whom it is manufactured is responsible for the allocation of the Global Trade Item. Number GTIN By joining a GS1 Member Organisation the company receives a GS1 Company. Prefix which is for the sole use of the company to which it is assigned The GS1 Company Prefix may. not be sold leased or given in whole or in part for use by any other company. The company that owns the product and makes the Regulatory Filing is responsible for the GTIN. Allocation For healthcare items it is common for national regulators to require the submission of a. product filing from a legal entity based within the jurisdiction of the regulator Such arrangements. have no direct impact on GTIN Allocation but need to be covered by the normal contractual. arrangements e g licensed distributor subsidiary reseller etc. The Brand Owner can only be responsible for GTIN Allocation until the item leaves their control For. example a complex medical device can be reconfigured e g new language updated software. etc Individual customer configuration therefore cannot impact GTIN Allocation. 4 2 2 Kitter, The kitter is the Responsible Entity that defines the kit contents specifications and labelling Within. the EU the kitter owns the CE mark The kitter may or may not assemble the kits and may engage. a third party or kit assembler to produce the finished trade items. 4 3 Guidelines for Allocating Global Trade Item Numbers. 4 3 1 Pre defined characteristics, Although this list is not exhaustive the basic pre defined characteristics of a trade item are. Product Name Product Brand and Product Description. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 10 of 26. GS1 Healthcare GTIN Allocation Rules,Formulation active ingredients. Dosage or usage, Net quantity weight volume or other dimension impacting trade. Packaging configuration,Form Fit or Function, For groupings the number of elementary items contained and their subdivision in sub. packaging units the nature of the grouping carton pallet box pallet flat pallet. A modification to any of the basic elements that characterise a trade item will usually lead to a. change in the GTIN,4 3 2 Lead time in re using a GTIN. Companies must ensure that GTINs allocated to Regulated Healthcare Trade Items shall never be. Exception Regulated Healthcare Trade Items that have been withdrawn from the market and are. reintroduced may use the original GTIN if they are reintroduced without any modifications or. changes which require a new GTIN as specified by the GTIN Allocation Rules As an example. Product A a first generation injectable antibiotic was withdrawn from the market by its. manufacturer due to declining sales After a 10 year absence from the market Product A was. reintroduced by the manufacturer in its original form and package configuration to treat infections. resistant to newer antibiotics In this example the original GTIN may be used. 4 3 3 Prepriced merchandise, Prepricing is discouraged as a trade practice as it introduces complexity for trade item file. maintenance through the Supply Chain However prepricing can be a mandatory requirement from. the regulatory authorities therefore if the price that the consumer will pay is marked on the item. the Global Trade Item Number GTIN should be changed when the priced marked on the item. 4 3 4 Trade item changes, Trade item changes are any change or improvement during the life of a trade item where the new. trade item replaces the old one Should the Brand Owner decide to create a variant e g with. different active ingredient in parallel with the standard trade item then a separate GTIN has to be. Minor trade item changes or improvements do not require the allocation of a different GTIN. Examples artwork colour changes outer packaging material change etc. Major trade item changes or improvements do require the allocation of a different GTIN Examples. If a trade item s quantity or measure changes or if any pre defined characteristics are modified. then a new GTIN must be allocated,4 4 Identification within a hierarchy. It is important that different levels within a hierarchy e g Single Unit or Single Unit Package. Shipper or Case Pallet etc are assigned different GTINs It is for the Brand Owner or Responsible. Entity to determine the hierarchy level s to which a GTIN should be assigned Typically any. hierarchy level that is priced or ordered or invoiced at any point in any Supply Chain should. receive its own GTIN In some healthcare applications this may also be recorded and included in. patient records, A typical hierarchy level example is shown in Figure 4 2 Example of Typical Pharmaceutical. Hierarchy Levels More detailed examples are provided at. http www gs1 org productssolutions idkeys, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 11 of 26. GS1 Healthcare GTIN Allocation Rules, Figure 4 2 Example of Typical Pharmaceutical Hierarchy Levels. Single Unit Each Case or Shipper Pallet,GTIN A GTIN B GTIN C GTIN D. Figure 4 3 Examples of Typical Medical Device Hierarchy Levels. Single Unit Package Case or Shipper Pallet,GTIN A GTIN B GTIN C. Single Unit Multiple Unit Case or,Package Package Shipper. GTIN A GTIN B GTIN C GTIN D, Note While the hierarchy level does not impact the GTIN of a specific item each different. grouping of the same item requires a separate GTIN as shown in Figure 4 2 Example of. Typical Pharmaceutical Hierarchy Levels and Figure 4 3 Examples of Typical Medical Device. Hierarchy Levels, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 12 of 26. GS1 Healthcare GTIN Allocation Rules, Note While GTINs are typically assigned to packaged items the GTIN Allocation Rules cover. scenarios for unpackaged items in section 5 1 1 Different language or target market and 5 3 6. Rules for single Unit, Note The pallet or logistic level can be identified with a GTIN for trade purposes and is. identified with a SSCC for logistics application,4 5 Takeovers. 4 5 1 Acquisitions and mergers, For the company being acquired existing stocks on hand which are numbered before the acquisition. or merger keep the same Global Trade Item Numbers GTINs Products that are produced after the. acquisition or merger may keep the GTIN allocated before the acquisition if the acquiring company. maintains the GS1 Member Organisation membership, A merger implies that a legal entity has taken over a company and has assumed responsibility for. the company s GS1 Company Prefix as well as their assets and locations Products that the. company produced under its GS1 Company Prefix can still be produced using the same prefix after. the merger as full responsibility for the GS1 Company Prefix is unaffected If it so desires the new. company can label all acquired products using only one of their existing GS1 Company Prefix. The importance of ensuring trading partners are informed of any changes in a timely manner. cannot be overemphasised A company should be careful when centralising the allocation of all. numbers under one GS1 Company Prefix thus changing the GTIN of the existing products which. are otherwise unchanged Centralising the allocation of all numbers under a single GS1 Company. Prefix should be an exception as it results in additional work and data file maintenance for. customers Companies should notify their GS1 Member Organisation of any legal status change. within one year to facilitate a smooth transition,4 5 2 Partial purchase. If a company purchases a division of a company whose GS1 Company Prefix is used in divisions not. purchased then the acquiring company must change the GTINs for products in the purchased. division within one year, In most cases the rules concerning the use of the seller s GTINs and other GS1 Identification Keys. should be taken into consideration when drawing up the purchase contract. At the earliest opportunity the buyer should phase in new numbers from its own range of numbers. for items whose brand name it has acquired The buyer will be able to do this for example when. packaging is redesigned or reprinted, Best practice in healthcare is that the selling company never reallocate the numbers used on. products which are divested to another company,4 5 3 Split or spin off. When a company splits into two or more separate companies it is necessary for each GS1 Company. Prefix assigned to the original company to be transferred to only one of the new companies Any. company left without a GS1 Company Prefix will need to apply to a GS1 Member Organisation to. obtain one The decision about which of the new companies should take the original GS1 Company. Prefixes should be made in such a way as to minimise the number of additional GTINs required The. decision should be part of the legal arrangements of the new companies. It is not necessary for existing stocks of items to be renumbered However when any of the split or. spin off companies has trade items that are numbered with a GS1 Company Prefix that it no longer. holds the company should renumber those items using its own GS1 Company Prefix when new. labelling or packaging is produced Customers should be notified well in advance of the changes. Split or spin off companies that retain a GS1 Company Prefix must keep a record of the GTINs. created that have been allocated to items they no longer own Best practice in healthcare is to never. reallocate the numbers used on products which are divested to another company. Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 13 of 26. GS1 Healthcare GTIN Allocation Rules,4 6 Data alignment. When a new GTIN is assigned to a trade item it is essential that the Brand Owner provide the. detailed information to trading partners about the item s characteristics see section 4 3 1 Pre. defined characteristics It is essential that the information associated with a GTIN is accurate and. communicated in a timely manner,4 6 1 Data alignment best practice. A number of actions are vital to ensure that GTINs are accurately communicated within the Supply. Chain These actions ensure that the data associated with any scanned barcode can be associated. with accurate up to date data This is particularly essential for items scanned in Healthcare Supply. Chains where the absence of accurate data may have safety product availability and or regulatory. conformance implications, The GTIN provides a Supply Chain solution for the identification of any item and overall Supply. Chain costs are minimised by all partners in the Supply Chain adhering to identical allocation rules. as laid down in this publication,5 GTIN Allocation scenarios. 5 1 General Rules, Although regulations see section 3 Regulators are extremely important in this area most Non. Prescription items follow broadly similar allocation rules to those in the general retail environment. see www gs1 org gtinrules The examples below focus on major healthcare specific scenarios not. found within the general retail environment, There is a clear overlap between Non Prescription products and both Medical Devices and. Prescription Rx drugs The general principles in this section apply to any type of healthcare item. 5 1 1 Different language or target market, Figure 5 1 New GTIN shows two otherwise identical products one targeted for an English speaking. country the other for a Spanish speaking country As the two items exist in parallel and cannot be. substituted due to market acceptance and local labelling laws a new language version to be sold in. one Market Country requires a different GTIN than the other that is sold in a different. Market Country,Figure 5 1 New GTIN, 5 1 2 Additional language on the packaging sold in several markets. Unlike the single language packaging see section 5 1 1 Different language or target market many. products are packed for multiple countries and markets Where there is an addition to an existing. language cluster the GTIN will remain the same, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 14 of 26. GS1 Healthcare GTIN Allocation Rules, Figure 5 2 Addition to an Existing Language Cluster Same GTIN. 5 1 3 Changes in packaging materials or minor artwork changes. Minor artwork changes or a minor change in packaging materials do not require the allocation of. different GTINs, Typically the gross dimensions of a trade item communicated via the Item File that do not affect net. trade item quantity or measure do not impact the GTIN assignment If dimensions are relevant. anywhere in the supply chain the general rule is that if any gross dimension e g length depth. weight etc changes by more than 20 a new GTIN is required Changes below 20 may require. a new GTIN at the discretion of the brand owner, Figure 5 3 Minor Change in Packaging Materials Same GTIN. Note Minor changes those which are not relevant to trading partners because they do not. impact the information concerning the exchange of products do not require a change of. 5 1 4 Promotions, Promotions are normally short term modifications to the way the item is presented Promotions. related to price do not impact GTIN allocation, Release 9 0 2 Ratified Dec 2015 2015 GS1 AISBL Page 15 of 26.
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