Track & Trace E.U. Compliance Version April Compliance Guide

Transcription

1 Track & Trace E.U. Compliance Version April 2018 Compliance Guide

2 Copyright 2018 Axway All rights reserved. This documentation describes the following Axway software: Axway Track & Trace - E.U. Compliance module No part of this publication may be reproduced, transmitted, stored in a retrieval system, or translated into any human or computer language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written permission of the copyright owner, Axway. This document, provided for informational purposes only, may be subject to significant modification. The descriptions and information in this document may not necessarily accurately represent or reflect the current or planned functions of this product. Axway may change this publication, the product described herein, or both. These changes will be incorporated in new versions of this document. Axway does not warrant that this document is error free. Axway recognizes the rights of the holders of all trademarks used in its publications. The documentation may provide hyperlinks to third-party web sites or access to third-party content. Links and access to these sites are provided for your convenience only. Axway does not control, endorse or guarantee content found in such sites. Axway is not responsible for any content, associated links, resources or services associated with a third-party site. Axway shall not be liable for any loss or damage of any sort associated with your use of third-party content.

3 Contents Accessibility 5 Screen reader support 5 Support for high contrast and accessible use of colors 5 Preface 6 Who should read this guide 6 Track & Trace documentation set 6 Training services 7 Support services 7 1 About E.U. Compliance 8 2 Prerequisites 10 3 Requirements 11 4 Activate E.U. Compliance 12 5 Log into the compliance UI 13 Permissions 13 6 About reports 14 Search criteria 14 Error management 16 Statuses for each report 21 Report generation 25 Product data report 25 Pack data report 32 Pack state update report 34 Batch recall report 34 Cutover for multimarket 35 Report details 35 Batch recall report details 36 Pack data report details 36 Pack state update report details 37 Product data report details 38 7 Manage settings 40 Connection parameters 40 Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 3

4 Schedule 41 Mappings 42 Product data 42 Pack data 42 MAH/Manufacturers/Wholesalers addressing 43 Report triggers 43 Pack data 43 Pack state update 44 8 Markets 45 9 Request Report notification 47 Appendix A: Product code Master Data Form values 48 Appendix B: Product code Master Data PackType values 61 Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 4

5 Accessibility The following describes the accessibility features of the documentation provided with Track & Trace. The product documentation provides the following accessibility features: Screen reader support Support for high contrast and accessible use of colors Screen reader support Alternative text is provided for images whenever necessary. The PDF documents are tagged to provide a logical reading order. Support for high contrast and accessible use of colors The documentation can be used in high-contrast mode. There is sufficient contrast between the text and the background color. The graphics have the right level of contrast and take into account the way color-blind people perceive colors. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 5

6 Preface This guide describes how to use the E.U. Compliance module, which is a solution that Track & Trace provides to connect to the European Medicines Verification System (EMVS) to facilitate data exchanges for products entering the European drug supply chain. E.U. Compliance v1.2 is a modular component of the Track & Trace solution. Who should read this guide This guide is intended for the configurator or administrator of the E.U. Compliance. Other technical or business users may find parts of this guide useful as well. Track & Trace documentation set The Track & Trace documentation set includes the following documents: Axway Track & Trace Installation Guide Explains how to install Track & Trace and how to upgrade Track & Trace to the latest version. Axway Track & Trace Administrator Guide Describes how to configure and start up Track & Trace. Axway Track & Trace Developer Guide Explains how to use each web service provided with Axway Track & Trace and the available user exits that enable you to customize your application environment to meet the needs of your organization. Axway Track & Trace User Guide Explains how to use the Track & Trace graphical user interface (GUI). Axway Track & Trace Release Notes Provides up-to-date information related to new features included in this release and known limitations. Axway Track & Trace and Axway B2Bi Interoperability Guide Describes how to configure Track & Trace and B2Bi to work together to provide a shared set of services. Axway Track & Trace Security Guide Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 6

7 Preface Provides instructions and recommendations to help you strengthen the security of the Track & Trace product and its communication with other Axway products including third party applications. Axway Track & Trace U.S. Compliance Guide Describes how to use the U.S. Compliance which is a solution that Track & Trace provides to manage data exchanges to comply with the law. Note All Axway documentation is available on Axway Support at Training services Axway offers training across the globe, including on-site instructor-led classes and self-paced online learning. For details, go to: Support services The Axway Global Support team provides worldwide 24 x 7 support for customers with active support agreements. support@axway.com or visit Axway Support at Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 7

8 About E.U. Compliance 1 The risk of falsified medicines is growing on a global scale. As a result, the European Union has stipulated a catalogue of measures in Directive 2011/62/EU to prevent falsified medicines from entering the legal supply chain. The EU Commission has published additional technical details for the further design of security features with the Delegated Regulation (EU) 2016/161 in the Official Journal of the European Union. Starting from February 9, 2019, only prescription medicines which bear the new safety features may be put into circulation. The European Medicines Verification Organization (EMVO) is a Belgian non-profit organization representing stakeholders united in securing the legal supply chain from falsified medicines. Its founding members are EFPIA (The European Federation of Pharmaceutical Industries and Associations), Medicines for Europe (The European Generic and Biosimilar Medicines Association), PGEU (The Pharmaceutical Group of the European Union), GIRP (The European Healthcare Distribution Association) and EAEPC (The European Association of Euro-Pharmaceutical Companies). In order to counter the threat of falsified medicines entering the legal supply chain, the European Parliament and Council have released a Directive on Falsified Medicines (2011/62/EU) (amending Directive 2001/83/EC). It aims at improving patient safety by mandating the Marketing Authorization Holders and manufacturers to put a system in place that is preventing falsified medicines from entering the legal supply chain, the European Medicines Verification System. The European Medicines Verification System (EMVS) should guarantee Medicines authenticity by an endto-end verification. Products that are in scope of the FMD are generally all prescription products with a few exceptions as specified in the Delegated Regulation (EU) 2016/161. While non-prescription products are largely not in scope, there are a few exceptions and more may be defined per market by national competent authorities. In essence, manufacturers will be required to print a Data Matrix code, which incorporates a unique identifier (UI) and apply an anti-tampering device on the outer packaging of all medicines for each individual sales package. At the point of dispense the medicine will be scanned, checked and verified for authenticity against a national (or supranational) repository. If the UI on the pack matches the information in the repository, the pack is decommissioned and supplied to the patient. Otherwise, if there is a warning related to this pack, then the system will highlight this as an exceptional event and the package will not be supplied to the patient. An investigation needs to determine whether the pack has been falsified or not. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 8

9 1 About E.U. Compliance Manufacturers can upload the unique identifiers via the European Hub and verification of medicines will take place in the National Medicines Verification Systems. The overall technical and quality standards, such as system interoperability, data ownership and access have been agreed by the stakeholders based on mutually endorsed principles that are compatible with the FMD requirements. Reference: EMVO medicines.eu Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 9

10 Prerequisites 2 Before activating Track & Trace E.U. Compliance, ensure that the Track & Trace product is installed and that your hardware platform meets the minimum requirements. For E.U. Compliance installation information, see AxwayTrack & Trace Installation Guide. For Track & Trace installation information, see Axway Track & Trace Installation Guide. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 10

11 Requirements 3 Before activating and using Track & Trace E.U. Compliance, become familiar with the following requirements. Master Data management EPCIS events added to the Track & Trace repository for E.U. Compliance purposes must conform with either EPCIS standard or 1.1. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 11

12 Activate E.U. Compliance 4 Once Track & Trace is installed and is operating correctly, you can activate E.U. Compliance. Once activated, E.U. Compliance provides: Dedicated settings Market settings Report management Product data report, Pack data report, Pack state update report and Batch recall report generation When E.U. Compliance is not activated: Product data report, Pack data report, Pack state update report and Batch recall report are not generated. For E.U. Compliance installation and activation information, see Axway Track & Trace Installation Guide. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 12

13 Log into the compliance UI 5 1. If SSL is configured, you can access the Track & Trace E.U. Compliance UI using: url, hostname refers to the machine name and portnumber is the port number of the application server defined in the following file on the server: <InstallDir>\server\conf\server.xml Note If you enable the plain http port, you can also access the UI using: eu/. In this case you will be automatically redirected to the HTTPS URL. The login window is displayed. 2. Enter your User name and Password. If you do not know your user name and password, ask your system administrator. 3. Click Log in. The home page of the UI is displayed. Permissions You must have the following user permissions if you want to: View and modify EU compliance settings Settings:Manage, Master Data:Manage and Query:Poll View EU compliance market EU Markets:View, Master Data:Manage and Query:Poll View and modify EU compliance market EU Markets:View, EU Markets:Update, Master Data:Manage and Query:Poll See the report list and report details EU Reports:View See the report list, report details, and manually send the report to the HUB in Sending error or Waiting status EU Reports:View, EU Reports:SendToHub Generate a batch recall report EU Reports:View, EU Reports:SendToHub, EU Reports:RecallBatch Request a report from the HUB EU Reports:View, EU Reports:Request Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 13

14 About reports 6 The reports page lists all the reports that are generated by the system: Batch recall: Recall distributed batch Pack data: Serial Numbers report Pack state update: Change serial number status Product data: Master Data report Reports are listed with the following information: Report type: Select the report type link to view the report details. Report date: The date the report was generated. Product: The product code is displayed in GTIN format (14 digits) or is displayed using the custom display defined in core settings. Batch: The batchid of the report. This batchid is empty for the Product Data report. Status / E.U Hub status: The current status of the report. Click on the report status to view the status history. To access reports: Click Reports on the left navigation bar. Search criteria The following search criteria are available on the reports page: Report date after / before: Select the report date after and / or before using the calendar. You can alternatively enter the date manually. By default, only reports with report date equal to current date are displayed. Report type: Select one or several report types. No type checked means no filtering on report type. Report status: Select one or several reports status. No status checked means no filtering on report status. o o All: To include all the report statuses. Generation error: (Track & Trace status) Error during the report generation. Error details are available from status history. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 14

15 6 About reports o o o o o o o o o o o o o o Waiting product data report: (Track & Trace status) Product data report has been successfully generated and is waiting for a final status of a previous Product data report. Or Pack data report is waiting for a final status of the corresponding Product data report. For details, see Error management on page 16. Waiting pack data report: (Track & Trace status) Pack state update report has been successfully generated and is waiting for a final status of the corresponding Pack data report. For details, see Error management on page 16. Waiting pack state update report: (Track & Trace status) Pack state update report has been successfully generated and is waiting for a final status of the previous Pack state update report. For details, see Error management on page 16. Ready to send: (Track & Trace status) Report has been successfully generated and control regarding final status of previous reports has been performed. Report is ready to be sent to the Hub. Sent to hub: (Track & Trace status) Report has been successfully sent to the Hub (Hub has sent a valid synchronous response). Sending error: (Track & Trace status) Report has not been sent to the Hub due to connection issue or a linked report in error. Error description is available from status history. For details, see Error management on page 16. Ready for verification: (Track & Trace status) Verification report has been successfully generated. Report is ready to be sent to the Hub. Verification sent: (Track & Trace status) Report has been successfully sent to the Hub (Hub has sent a valid synchronous response). Verification success: (Track & Trace status) Hub has sent an asynchronous response in Success status. Verification error: (Track & Trace status) There are errors in the verification. Either there is no serial number matching the initial status or there is an error raised by the Hub. Error description is available from status history. For details, see Error management on page 16. Valid: (Hub status) Hub has sent an asynchronous response in Valid status. Applicable to Product data report, Pack data report and Batch recall report. Invalid: (Hub status) Hub has sent an asynchronous response in Invalid status. Applicable to Product data report, Pack data report and Batch recall report. Error description is available from status history. For details, see Error management on page 16. Loaded: (Hub status) Hub has sent an asynchronous response in Loaded status. Applicable to Product data report and Pack data report. Distributed: (Hub status) Hub has sent an asynchronous response in Distributed status. Applicable to Product data report, Pack data report and Batch recall report. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 15

16 6 About reports o o o Distribution failed: (Hub status) Hub has sent an asynchronous response in Distribution failed status. Applicable to Product data report and Pack data report. Error description is available from status history. For details, see Error management on page 16. Success: (Hub status) Hub has sent an asynchronous response in Success status. Applicable to Pack state update report and Batch recall report. Fail: (Hub status) Hub has sent an asynchronous response in Fail status. Applicable to Pack state update report and Batch recall report. Error description is available from status history. For details, see Error management on page 16. Product: Select the product. No value means no filtering on product. Batch ID: Enter the report Batch ID. It applies to Pack data report and Pack state update report. When you click Apply, the system retrieves the reports matching your search criteria. Error management In case of Generation error, Sending error, Invalid, Fail, Distributed failed or Verification error status: Click the status from the reports list to access the error message and the corresponding error code. Note The date and time displayed in status history correspond to the Timestamp given in the report. Time is displayed in the UI using the Track & Trace server timezone. If an error occurs during the sending of the report (Sending error status) or if a report is stuck in a waiting status (Waiting product data report, Waiting pack data report, Waiting pack state update report status), you can manually send the report to the Hub: 1. Click the report status to access the status history. 2. Click Send to Hub. notification can be defined in Settings depending on the error status. For details, see notification on page 47. In status history and notification (%errormessage% variable) errors are displayed with this format: <errorsource> - <errorcountrycode> - <errorcode> - <errordescription> where: <errorsource> is retrieved from the Source attribute in case of response from the Hub, or is equal to Track & Trace in case of error at Track & Trace side (Generation error or Sending error). Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 16

17 6 About reports <errorcountrycode> is retrieved from the CountryCode attribute in case of response from the Hub, or is null in case of error at Track & Trace side. <errorcode> is retrieved from the Code field in case of response from the Hub, or is null in case of error at Track & Trace side. For more information about error code, refer to the documentation supplied with your connection pack. <errordescription> is retrieved from the Description field in case of response from the Hub, or is the error description in case of error at Track & Trace side. If the answer from the Hub contains several errors, Track & Trace will display all of them with a carriage return separator. Pack errors: A Download Hub response link is available from status history to download the response from the Hub. The Hub response is attached to the notification. Verification error: This status is raised in the following use cases: The serial number does not match the initial status of the Pack state update report. As a result, the report will not contain a serial number to update. An error is raised by the Hub. The error details can be downloaded from the error history for investigation. Batch recall error: Distribution failed: a Download Hub response link is available from status history to download the response from the Hub. The following table list the error / waiting statuses and possible remediation: Report Status Possible remediation Product data Waiting Product data report Report is stuck without any reason. Action: Click the Send to Hub button in the report history page to force the sending of the report. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 17

18 6 About reports Report Status Possible remediation Generation error Error due to a missing Master Data attribute. Action: Add the missing attributes in the appropriate Master Data and save. The system will automatically trigger a new report. Error due to bad Master Data mapping. Action: Fix the mapping and change the Market activation date in the past to retrigger the Product data report generation. Sending error Invalid Distribution failed Action: Click the Send to Hub button in the report history page to re-submit the report. If the same error occurred again, check the E.U. Hub connectivity with your IT department. Action: Ask the configurator to verify that the E.U. Hub settings are correct (Settings / connection parameters). If settings have not changed recently, open an Axway support case. This is an EMVO Hub issue. Action: Open a case at EMVO support for further investigation. Pack data Waiting Product data report Report is stuck without any reason. Action: Click the Send to Hub button in the report history page to force the sending of the report. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 18

19 6 About reports Report Status Possible remediation Generation error Error due to missing Batch ID or Expiry date. Action: Add the missing information to the new captured events. Re-capture an event. Mapping issue. Action: Check your mapping settings (Settings / mappings / Pack Data attributes). Recapture an event. Sending error Invalid Distribution failed Action: Click the Send to Hub button in the report history page to re-submit the report. If the same error occurred again, check the E.U. Hub connectivity with your IT department. Action: Ask the configurator to verify that the E.U. Hub settings are correct (Settings / connection parameters). If settings have not changed recently, open an Axway support case. Action: Open a case at EMVO support for further investigation. Pack state update Waiting for Pack data Waiting for Pack state update Report is stuck without any reason. Action: Click the Send to Hub button in the report history page to force the sending of the report. Report is stuck without any reason. Action: Click the Send to Hub button in the report history page to force the sending of the report. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 19

20 6 About reports Report Status Possible remediation Generation error Verification error Error due to missing Batch ID or Expiry date. Action: Add the missing information to the new captured events. Re-capture an event. The message: "T&T - After verification, no serial numbers match statuses that can be updated" is displayed in the error list. Action: None. There are no serial numbers to update. Any other error message: Action: Open a case at EMVO support for further investigation. Sending error Fail Action: Click the Send to Hub button in the report history page to re-submit the report. If the same error occurred again, check the E.U. Hub connectivity with your IT department. Action: Open a case at EMVO support for further investigation. Batch recall Sending error Action: Click the Send to Hub button in the report history page to re-submit the report. If the same error occurred again, check the E.U. Hub connectivity with your IT department. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 20

21 6 About reports Report Status Possible remediation Invalid Distribution failed Action: Ask the configurator to verify that the E.U. Hub settings are correct (Settings / connection parameters). If settings have not changed recently, open an Axway support case. Action: Open a case at EMVO support for further investigation. Fail Action: Open a case at EMVO support for further investigation. Statuses for each report The European Hub accepts a Pack data report only if the corresponding Master Data have been received and distributed via a Product data report. Similarly, the European Hub accepts a Pack state update report only if the corresponding Pack data report (same product, batch ID and expiry date) has been received and distributed to the national system. Lastly, the Batch recall is accepted by European Hub only if the corresponding Pack data report has been received and distributed. Based on these rules, the Track & Trace system sends a report only if the linked report has the appropriated status. Otherwise, the report will have a "waiting..." status. The following table list the statuses per report: Report Status Description Product data Waiting Product data report Current report is waiting for a previous Product data report processing for the same product. Previous report status for waiting are: Sent to hub / Valid / Loaded Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 21

22 6 About reports Report Status Description Generation error Track & Trace is not able to prepare the report. See Error management on page 16. Ready to send Temporary status. Sending error Track & Trace is not able to send the report to the E.U. Hub due to a technical error. See Error management on page 16. Sent to hub Valid / Invalid Loaded Distributed / Distribution failed Report is submitted to the E.U. Hub. E.U. Hub has validated the content of the report. E.U. Hub is unable to validate the content of the report. See Error management on page 16. E.U. Hub has taken into account the new product. E.U. Hub has distributed the Product to the require market(s). An error occurred while distributed the product across the market(s). See Error management on page 16. Notes: Product data report will not wait for a previous Product data report having the following statuses: Generation error / Invalid / Distributed / Distribution failed. Instead, it will create a new report version. Pack data Waiting Product data report Current Pack data report is waiting for a Product data distributed status. Generation error Track & Trace is not able to prepare the report. See Error management on page 16. Ready to send Temporary status. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 22

23 6 About reports Report Status Description Sending error Track & Trace is not able to send the report to the E.U. Hub due to technical error. See Error management on page 16. This status can be set after a "Waiting Product data report" status if: The final status of the corresponding Product data report is changed to Generation error, Invalid or Distribution failed. Sent to hub Valid / Invalid Distributed / Distribution failed Report is submitted to the E.U. Hub. E.U. Hub has validated the content of the report. E.U. Hub is unable to validate the content of the report. See Error management on page 16. E.U. Hub has distributed the Product to the require market(s). An error occurred while distributed the Product across the market(s). See Error management on page 16. Notes: Pack state update Waiting for Pack state Current Pack state update report is waiting for a Pack data distributed. Waiting for Pack state update Current Pack state update report is waiting for another Pack state update report. Generation error Track & Trace is not able to prepare the report. See Error management on page 16. Ready for verification Temporary status. Verification sent (optional step) Verification report is submitted to the E.U. Hub. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 23

24 6 About reports Report Status Description Verification error / Verification success Sending error E.U. Hub encountered an issue during the verification phase. See Error management on page 16. E.U. Hub returned the verification status correctly. Track & Trace is not able to send to the E.U. Hub the report due to technical error. See Error management on page 16. This status can be set after a "waiting..." status if: The final status of the corresponding Pack data report is changed to Generation error, Invalid or Distribution failed. or The final status of the previous Pack state update report is changed to Generation error or Fail. Sent to Hub Success Fail Report is submitted to the E.U. Hub. E.U. Hub succeeded in changing the Serial Number statuses. E.U. Hub failed to change the Serial Number statuses. See Error management on page 16. Notes: Batch recall Ready to sent Temporary status. Sending error Track & Trace is not able to send to the E.U. Hub the report due to technical error. See Error management on page 16. Sent to Hub Report is submitted to the E.U. Hub. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 24

25 6 About reports Report Status Description Valid / Invalid Distributed / Distribution failed Success / Fail E.U. Hub has validated the content of the report. E.U. Hub is unable to validate the content of the report. See Error management on page 16. E.U. Hub has distributed the Batch recall to the require market(s). An error occurred while distributed the Batch recall across the market(s). See Error management on page 16. E.U. Hub succeeded in recalling the batch. E.U. Hub failed to recall the batch. See Error management on page 16. Notes: Report generation This section contains the prerequisites for the generation of the Product data report, Pack data report, Pack state update report and Batch recall report. Product data report The Product data report is used to send drug information, such as: product code, product name, common name, form, strength, pack size and pack type. This report lists the markets on which the product is distributed, along with the corresponding Marketing Authorization Holder and Wholesalers' information. Three types of Master Data are needed for Product data report generation: Product code, sourcedest and market:product. To set up the Product data report generation, perform the following steps: 1. Define the company prefix in Product ID Verification Settings. 2. In Settings, define the connection parameters to the E.U Hub. 3. In Settings, define the mapping for product code if the attributes present in the Master Data repository are not the default attributes. 4. In Settings, define the mapping for MAH and Wholesalers addressing if the attributes present in the Master Data repository are not the default attributes. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 25

26 6 About reports Note Steps 1 through 4 are only required once. Perform steps 5 through 7 every time thereafter. 5. Import the product code Master Data. 6. Import the SourceDest Master Data for MAH and Wholesalers addressing. 7. Import the market:product Master Data to link the markets and the products The Product data report is automatically generated and sent to the Hub when the market is activated. Product code Master Data All products in the European market must have following product code Master Data attributes (type="urn:epcglobal:epcis:vtype:epcclass"): Name CommonName Form Strength PackSize PackType If Name, CommonName, Form, Strength, PackSize and PackType attributes are different from the default names, a mapping can be provided in Settings. Note Form and PackType attributes values must comply with enumerations. For the complete list, see Product code Master Data Form values on page list all the markets in which this product is sold. The format is ISO code with comma separators (Example: FR,DE). This attribute is used by the UI to display the list of products for a given market. The Product data report is automatically generated for a given product if one of the attributes is modified and if the product is used in an active market. Product code Master Data sample This sample includes two products: Epcistra 100 for FR and DE markets, and Epcistra 500 for FR market: <?xml version="1.0" encoding="utf-8" standalone="yes"?> <epcismd:epcismasterdatadocument Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 26

27 6 About reports xmlns:epcismd="urn:epcglobal:epcis-masterdata:xsd:1" xmlns:epcis="urn:epcglobal:epcis:xsd:1" xmlns:epcglobal="urn:epcglobal:xsd:1" schemaversion="1.1" creationdate=" t09:30:47.0z"> <EPCISBody> <VocabularyList> <!-- **************************** PRODUCTS ********************************** ***** --> <Vocabulary type="urn:epcglobal:epcis:vtype:epcclass"> <VocabularyElementList> <VocabularyElement id="urn:epc:idpat:sgtin: *"> <!-- <attribute id="name">epcistra 100</attribute> --> <attribute id="productname">epcistra 100</attribute> <attribute id="commonname">epcistra 100</attribute> <attribute id="form">cream</attribute> <attribute id="strength">100mg</attribute> <attribute id="packsize">50</attribute> <attribute id="packtype">jar</attribute> <attribute id=" TargetMarket">FR,DE</attribute> </VocabularyElement> </VocabularyElementList> </Vocabulary> <Vocabulary type="urn:epcglobal:epcis:vtype:epcclass"> <VocabularyElementList> <VocabularyElement id="urn:epc:idpat:sgtin: *"> <!-- <attribute id="name">epcistra 500</attribute> --> <attribute id="productname">epcistra 500</attribute> <attribute id="commonname">epcistra 500</attribute> <attribute id="form">syrup</attribute> <attribute id="strength">500mg</attribute> <attribute id="packsize">20</attribute> <attribute id="packtype">jar</attribute> <attribute id=" TargetMarket">FR</attribute> </VocabularyElement> </VocabularyElementList> </Vocabulary> </VocabularyList> </EPCISBody> </epcismd:epcismasterdatadocument> market:product Master Data Master Data type="axway:settings:market:product" is used to define, for a given market, the product and the associated Marketing Authorization Holder and the list of Wholesalers. The Markets details UI is using the Master Data to display the information. The following attributes are with type="urn:eu:market": URI of the market Master Data. The Markets are automatically added to the Master Data repository when the EU compliance is installed. The list is available in Manage Master Data > Other > Type=market epcclass: Product code in SGTIN format serializationflag: true or false nationalcode: Optional - National code article57: Optional - Product description Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 27

28 6 About with type="urn:epcglobal:epcis:vtype:sourcedest": Marketing Authorization Holder in SGLN with type="urn:epcglobal:epcis:vtype:sourcedest": Optional - Wholesaler in SGLN format. For multiple occurrences of Wholesaler, N must be unique (for example for 2 wholesalers When one of the Master Data attributes is modified or added from a Master Data import or when the market is edited from the UI, the Product data report is automatically generated for the corresponding products. Note These Master Data are not visible from Master Data management. market:product Master Data sample In this sample, Epcistra 100 is linked to one MAH and two wholesalers for FR market, to a different MAH and one wholesaler for DE market. Epcistra 500 is linked to one MAH and two wholesalers for FR market only. <?xml version="1.0" encoding="utf-8" standalone="yes"?> <epcismd:epcismasterdatadocument xmlns:epcismd="urn:epcglobal:epcis-masterdata:xsd:1" xmlns:epcis="urn:epcglobal:epcis:xsd:1" xmlns:epcglobal="urn:epcglobal:xsd:1" schemaversion="1.1" creationdate=" t09:30:47.0z"> <EPCISBody> <VocabularyList> <!-- **************************** Market/Product ******************************** ******* --> <Vocabulary type="axway:settings:market:product"> <VocabularyElementList> <VocabularyElement id="urn:eu:market:fr_urn:epc:idpat:sgtin: *"> <attribute id="@market" type="urn:eu:market">urn:eu: market:fr</attribute> <attribute id="epcclass">urn:epc:idpat:sgtin: *</attribute> <attribute id="serializationflag">true</attribute> <attribute id="nationalcode">nat_code</attribute> <!-- Article 57 definition --> <attribute id="article57">epcistra 100 description for FR</attribute> <!-- Marketing Authorization Holder --> <attribute id="@mah" type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> <!-- Wholesalers --> <attribute id="@wholesaler#1" type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> <attribute id="@wholesaler#2" type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> </VocabularyElement> <VocabularyElement id="urn:eu:market:de_urn:epc:idpat: sgtin: *"> <attribute id="@market" type="urn:eu:market">urn:eu: market:de</attribute> <attribute id="epcclass">urn:epc:idpat:sgtin: *</attribute> <attribute id="serializationflag">true</attribute> <attribute id="nationalcode">nat_code</attribute> Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 28

29 6 About reports <!-- Article 57 definition --> <attribute id="article57">epcistra 100 description for DE</attribute> <!-- Marketing Authorization Holder --> <attribute type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> <!-- Wholesalers --> <attribute type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> </VocabularyElement> <VocabularyElement id="urn:eu:market:fr_urn:epc:idpat:sgtin: *"> <attribute type="urn:eu:market">urn:eu:market: fr</attribute> <attribute id="epcclass">urn:epc:idpat:sgtin: *</attribute> <attribute id="serializationflag">true</attribute> <attribute id="nationalcode">nat_code</attribute> <!-- Article 57 definition --> <attribute id="article57">epcistra 500 description for FR</attribute> <!-- Marketing Authorization Holder --> <attribute type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> <!-- Wholesalers --> <attribute type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> <attribute type="urn:epcglobal:epcis:vtype:sourcedest">urn:epc:id:sgln: </attribute> </VocabularyElement> </VocabularyElementList> </Vocabulary> </VocabularyList> </EPCISBody> </epcismd:epcismasterdatadocument> SourceDest Master Data All of the Marketing Authorization Holders and Wholesalers for the European market must have the following addressing Master Data attributes (type="urn:epcglobal:epcis:vtype:sourcedest"): Name Street Street2 City Postcode CountryCode If Name, Street, Street2, City, Postcode,and CountryCode attributes are different from the default ones, a mapping can be provided in Settings. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 29

30 6 About reports list all the markets in which MAH, wholesaler or Manufacturer, operates. The Format is ISO code with comma separators (Example: FR,DE). This attribute is used by the UI to display the list of available MAH and Wholesalers for a given market. is equal to MAH for Marketing Authorization Holder or WHOLESALER for wholesaler. This attribute is used by the UI to display the list of MAH or the list of wholesalers. The Product Data report is automatically generated for all the products used by the MAH or Wholesalers if one of the attribute is modified and if the product is used on an active market. SourceDest Master Data sample In this sample, Epcistra 100 is linked to two MAH (one for French market and one for German market), three Wholesalers (two for French market and one for German market) and Manufacturer. <?xml version="1.0" encoding="utf-8" standalone="yes"?> <epcismd:epcismasterdatadocument xmlns:epcismd="urn:epcglobal:epcis-masterdata:xsd:1" xmlns:epcis="urn:epcglobal:epcis:xsd:1" xmlns:epcglobal="urn:epcglobal:xsd:1" schemaversion="1.1" creationdate=" t09:30:47.0z"> <EPCISBody> <VocabularyList> <!-- **************************** SOURCE DEST *********************************** **** --> <Vocabulary type="urn:epcglobal:epcis:vtype:sourcedest"> <VocabularyElementList> <!-- **************************** MAH *************************************** --> <VocabularyElement id="urn:epc:id:sgln: "> <!-- <attribute id="id">123</attribute> <attribute id="name">mah FR</attribute> --> <attribute id="companyname">mah FR</attribute> <attribute id="street">3 Rue du Pre Faucon</attribute> <attribute id="street2">bat 3 Room 120</attribute> <attribute id="city">annecy-le-vieux</attribute> <attribute id="postcode">74940</attribute> <attribute id="countrycode">fr</attribute> <attribute id=" FR</attribute> <attribute id=" </attribute> </VocabularyElement> <VocabularyElement id="urn:epc:id:sgln: "> <!-- <attribute id="id">123</attribute> <attribute id="name">mah DE</attribute> --> <attribute id="companyname">mah DE</attribute> <attribute id="street">1 Katze Straße </attribute> <attribute id="street2"></attribute> <attribute id="city">berlin</attribute> <attribute id="postcode">598</attribute> <attribute id="countrycode">de</attribute> <attribute id=" DE</attribute> <attribute id=" </attribute> </VocabularyElement> Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 30

31 6 About reports <!-- **************************** WHOLESALER ************************************ *** --> <VocabularyElement id="urn:epc:id:sgln: "> <!-- <attribute id="id">w1</attribute> <attribute id="name">wholesaler1 FR</attribute> --> <attribute id="companyname">wholesaler1 FR</attribute> <attribute id="street">50 rue Clemenceau</attribute> <attribute id="street2">bat. 2</attribute> <attribute id="city">paris</attribute> <attribute id="postcode">75001</attribute> <attribute id="countrycode">fr</attribute> <attribute id=" </attribute> <attribute id=" </attribute> </VocabularyElement> <VocabularyElement id="urn:epc:id:sgln: "> <!-- <attribute id="id">w1</attribute> <attribute id="name">wholesaler DE</attribute> --> <attribute id="companyname">wholesaler DE</attribute> <attribute id="street">69 Hund Straße</attribute> <attribute id="street2"></attribute> <attribute id="city">berlin</attribute> <attribute id="postcode">125</attribute> <attribute id="countrycode">de</attribute> <attribute id=" DE</attribute> <attribute id=" </attribute> </VocabularyElement> <VocabularyElement id="urn:epc:id:sgln: "> <!-- <attribute id="id">w2</attribute> <attribute id="name">wholesaler2 FR</attribute> --> <attribute id="companyname">wholesaler2 FR</attribute> <attribute id="street">5 avenue des champs elysee</attribute> <attribute id="street2"></attribute> <attribute id="city">paris</attribute> <attribute id="postcode">75002</attribute> <attribute id="countrycode">fr</attribute> <attribute id=" </attribute> <attribute id=" </attribute> </VocabularyElement> <!-- **************************** MANUFACTURER ************************************* ** --> <VocabularyElement id="urn:epc:id:sgln: "> <!-- <attribute id="id">m1</attribute> <attribute id="name">manufacturer</attribute> --> <attribute id="companyname">manufacturer</attribute> <attribute id="street">chemin de poesy</attribute> <attribute id="street2"></attribute> <attribute id="city">poisy</attribute> <attribute id="postcode">74330</attribute> <attribute id="countrycode">fr</attribute> </VocabularyElement> </VocabularyElementList> </Vocabulary> </VocabularyList> </EPCISBody> </epcismd:epcismasterdatadocument> Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 31

32 6 About reports Pack data report The Pack data report is used to send the pack information for a given product, such as: the Batch ID, the batch expiry date and the pack size. The Pack data report also includes Manufacturer information and a list of all the serial numbers linked to this batch. Each Pack data report can contain up to 1 million serial numbers for a batch. If a batch contains more than 1 million serial numbers in a commissioning event, the Track & Trace system will generate additional Pack data reports to be submitted to the E.U. Hub. For a given product, the Pack data report is accepted by the Hub only if corresponding Master Data was already sent to the Hub with the Product data report. The Track & Trace system retrieves: Batch ID, Expiry date and Manufacturer GLN from the EPCIS event retrieved by the schedule query that was defined in Settings. Pack size from Product code Master Data. Manufacturer addressing from sourcedest Master Data. To set up the Pack data report generation, perform the following steps: 1. Import the SourceDest Master Data for Manufacturer addressing. 2. In Settings, define the connection parameters to the EU Hub. 3. In Settings, define the mapping for Manufacturer addressing if the attributes present in Master Data repository are not the default attributes. 4. In Settings, define the mapping for Batch ID and Expiry date if your are not using the default values. 5. In Settings, define the report trigger for the Pack data report and the frequency. Each time an EPCIS event matching the defined trigger is captured, the event is retrieved automatically by the defined query and the corresponding report is generated and sent to the Hub. SourceDest Master Data The Pack data report contains Manufacturer addressing that is retrieve from the Master Data attributes (type="urn:epcglobal:epcis:vtype:sourcedest"): Name Street Street2 City Postcode CountryCode Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 32

33 6 About reports If Name, Street, Street2, City, Postcode, CountryCode attributes are different from the default attributes, map them in Settings. EPCIS events EPCIS event for the Pack data report must contain all the serial numbers for the same product and Batch ID. The manufacturer SGLN is mandatory and is retrieved by default in the event source with type="urn:epcglobal:cbv:sdt:owning_party". In case of custom extension usage, a mapping has to be defined in Settings. The format of the Manufacturer extension value must be in GLN (13 digits) or SGLN (URI). If the extension contains a GLN (13 digits), then the corresponding company prefix must be defined in Product ID Verification Settings to convert the GLN to SGLN (URI). If company prefix is not found during the report generation, then it will be in error. If source with type="urn:epcglobal:cbv:sdt:owning_party" is not present in event, the system will retrieve the Manufacturer SGLN from BizLocation. Batch ID and Expiry date are mandatory and are retrieved by default in the event ILMD extension and In case of custom extension usage, a mapping must be defined in Settings. Sample of commissioning event use for Pack data report <?xml version="1.0" encoding="utf-8" standalone="yes"?> <epcis:epcisdocument creationdate=" t15:24:00z" schemaversion="1.1" xmlns:epcis="urn:epcglobal:epcis:xsd:1" xmlns:axway=" <EPCISBody> <EventList> <ObjectEvent> <eventtime> t18:09: :00</eventtime> <eventtimezoneoffset>+01:00</eventtimezoneoffset> <epclist> <epc>urn:epc:id:sgtin: </epc> <epc>urn:epc:id:sgtin: </epc> <epc>urn:epc:id:sgtin: </epc> <epc>urn:epc:id:sgtin: </epc> <epc>urn:epc:id:sgtin: </epc> <epc>urn:epc:id:sgtin: </epc> </epclist> <action>add</action> <bizstep>urn:epcglobal:cbv:bizstep:commissioning</bizstep> <disposition>urn:epcglobal:cbv:disp:active</disposition> <extension> <quantitylist> <quantityelement> <epcclass>urn:epc:class:lgtin: Lot1</epcClass> </quantityelement> Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 33

34 6 About reports </quantitylist> <sourcelist> <source type="urn:epcglobal:cbv:sdt:owning_party"> urn:epc:id:sgln: </source> </sourcelist> <ilmd> <axway:lotnumber>l1</axway:lotnumber> <axway:itemexpirationdate> </axway:itemexpirationdate> </ilmd> </extension> <axway:trigger>true</axway:trigger> </ObjectEvent> </EventList> </EPCISBody> </epcis:epcisdocument> Pack state update report The Pack state update report is used to change the Hub status of a list of serial numbers. For a given product / batch ID and a given list of serial numbers, Pack state update report is accepted by the Hub only if the corresponding Pack data report has already been sent to the Hub. The Track & Trace system retrieves the Batch ID and Expiry date from the EPCIS event captured by the schedule query defined in Settings. Similarly to the Pack data report, Batch ID and Expiry date are mandatory and are retrieved by default in the event ILMD extension and In case of custom extension usage, a mapping must be defined in Settings. To set up the Pack state update report generation, perform the following steps: 1. In Settings, define the connection parameters to the E.U. Hub. 2. In Settings, define the mapping for Batch ID and Expiry date if your are not using the default values. 3. In Settings, define the report trigger for the Pack state update report and the frequency and corresponding Initial Pack state and New Pack state. Select the Verification check box to define whether the Pack state update report should be verified prior to sending it. By default, no verification is done. Each time an EPCIS event matching the defined trigger is captured, the event is retrieved automatically by the defined query and the corresponding report is generated and sent to the Hub. Batch recall report The Batch recall report is used to recall a distributed batch. For a given product / batch ID, the Batch recall report is accepted by the Hub only if the corresponding batch ID from the Pack data report has a distributed status. Axway Track & Trace - E.U. Compliance 1.2 Compliance Guide 34