Canadian GTIN Allocation Rules for Healthcare - GS1

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Healthcare GTIN Allocation Rules 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. 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 5.3.1, 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 bar code 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 Rule Interpretation & Resolution As the industry moves forward, trading partners may reach different interpretations of the agreed upon standards. These may need clarification or a method may be required for resolving disputes. The following recommended resolution process should be observed in the event of an issue between trading partners. Step 1: Trading Party Resolution Clarify that the issue falls within the GTIN Allocation Rule recommendations (i.e. verify the issue relates to established product identification guidelines). These guidelines were developed through a lengthy consultation process to ensure that the business requirements of all stakeholders were met. 03 October 2007, Final All contents copyright © GS1 2007 Page 14 of 26
Healthcare GTIN Allocation Rules Most issues can be resolved through discussion between the trading partners in order to gain a thorough understanding of the issues at hand. GS1 encourages all trading partners to exhaust this avenue as the first and most direct course of action. Step 2: Industry Ombudsman Recommendation If trading partner dialogue does not facilitate a resolution the issue can be raised to the level of the GTIN Industry Ombudsman (GS1 Canada). The GTIN Ombudsman’s Role 1. Provide GTIN Allocation Rule subject matter expertise • Bring clarity to industry standards and best practice guidelines 2. Remain neutral and guide the parties to a feasible resolution • Propose a path forward Either trading partner may request the services of the Industry Ombudsman. The Ombudsman can be reached by email at GS1 Canada: GTINOMBUDSMAN@gs1ca.org Step 3: GS1 Sector Board Recommendation If the issue cannot be resolved to the mutual satisfaction of all, then an official complaint can be registered with the GS1 Chief Standards Officer. The complainant shall submit a description of the issue, the Industry Ombudsman’s recommendation(s) and why this approach cannot be implemented The matter will be tabled with the appropriate GS1 Sector Board (Pharmacy or Healthcare) for consideration at their next meeting. The Board will consider the impact of the recommended solution on both the affected trading parties and on the Industry as a whole. The Board will provide its written recommendation on how the matter can best be resolved. Either trading partner may request escalation to the appropriate GS1 Canada sector Board. The GS1 Canada Chief Standards Officer can be reached by email using the Ombudsman email: GTINOMBUDSMAN@gs1ca.org . 6. GTIN Allocation Scenarios 6.1. Over the Counter (OTC) 6.1.1. General Rules and Over the Counter (OTC) Although regulations (see Section 3, Regulators) are extremely important in this area, most Over The Counter 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. 03 October 2007, Final All contents copyright © GS1 2007 Page 15 of 26
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Canadian GTIN Allocation Rules for Healthcare - GS1

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