Managing Product Master Data

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1 Managing Product Master Data

2 Table of Contents Managing Product Master Data 3 Product Information 4 Adding Product Master Data 5 Updating Products 27 Accessing Product Master Data 28 Exporting Product Master Data 29 TraceLink, Inc. ("TraceLink") owns all right, title to, and interest in TraceLink's methodologies, processes, services, software programs and/or the licensed TraceLink training materials. The training materials are informational in nature and do not constitute a warranty of TraceLink. The licensed use of the Tracelink training materials is solely in conjunction with the licensed use of applicable TraceLink services and/or software programs. Any reproduction or modification of the TraceLink training materials is prohibited. This training material is confidential and can only be used by an authorized customer or partner. TraceLink, Inc. Copyright All rights reserved. Copyright 2017 TraceLink Page 2 10/6/2017

3 Managing Product Master Data Learning Objectives At the end of this module, you will be able to: Add products and their serialization attributes to Product Master Data. Overview You must configure Product Master Data for each product and packaging level. To add and update products in Product Master Data, you must be a Service Administrator of your company s Master Data Exchange service. Maintaining up-to-date product data is critical because TraceLink uses the data for compliance local to the U.S. (in Product Track US), serialization, and global compliance. Serialization and Global Compliance In order to serialize products, you'll need to enter information about those products in Product Master Data. TraceLink uses information from product master data to perform serialized operations across the system including packaging hierarchy, commissioning, and global compliance reporting. For example, packaging codes define packaging levels and are used to create serial number templates. Each product must contain specific item information that includes descriptive fields including the language the item will be sold in. In addition, you'll enter the markets in which the product will be sold. The governing agency of each locale has a different set of requirements for selling products into or exporting product from its locale. In order to maintain compliance with those locales, you must maintain the Product Master Data requirements of each specific locale. Product Master Data and US DSCSA When manufacturers and wholesalers ship product, TraceLink generates Transaction Histories and sends them to the entity receiving the product. When the physical product arrives at the recipient location, the wholesaler or dispenser receives the product in their ERP system and also in TraceLink. These operations can be automated or operators can use the TraceLink interface to perform shipping and receiving. In order for TraceLink to create and send Transaction Histories, Product Master Data must exist for the items in a shipment. When you add products, you will add general attributes such as the item code and status, as well as attributes specific to US DSCSA compliance. Copyright 2017 TraceLink Page 3 10/6/2017

4 TraceLink uses Product Master Data to create transaction histories by: Retrieving product entries from Master Data using the item code (for example, NDC). Populating the fields in transaction histories using the product information. Working with Product Master Data in TraceLink To access the Product Master Data page, you use the Master Data Exchange > Product item in the Modules menu. You can only access this menu item if you have been added to the Master Data Exchange service. To view Product Master Data, you must be a Service Member of the Master Data Exchange service. You ll need someone who is a Service Administrator of the Master Data Exchange service to assign you this role. To add or update Product Master Data, you must be a Service Administrator for the Master Data Exchange service. Your Company Administrator assigns this role. Product Information When you add products to Product Master Data, you specify the following data: Item Codes: Identifies the product with an item code type and its corresponding value. You can specify multiple item code types, selecting one as the primary item code type. The primary item code type is the code type your company uses to transmit product identifiers for electronic transactions. Target Markets: Identifies the countries into which the product will be sold. You ll identify whether traceability is required for the product, as well as the role your company plays for the purchase product originator, for example. Export Markets: Identifies the countries which the product will be exported from and into. You ll enter export from and to countries, indicating the unit price and currency code, as well as any applicable exemptions (for India only). Item Information: Identifies the product s specifications. You ll create item information in each language and locale where the product is sold. Packaging Information: Identifies the packaging levels and serialization method for each product (not needed for lot-level or dispensers). To add products, you must be a Service Administrator for the Master Data Exchange service. See Adding Users to the Master Data Exchange Service for details. Copyright 2017 TraceLink Page 4 10/6/2017

5 Adding Product Master Data To add products, you add Product Master Data, including information such as the product identifier, its name, strength, and dosage format (for example, tablets). Tips: If you sell in markets outside of the manufacturing location, you need to add export information in the Target Markets tab. Do not use the Export Markets tab unless the product is manufactured in India. If you sell into markets with serialization requirements, you need to add packaging information in the Packaging Information tab. Add a Product The following procedure shows how to add a product in the TraceLink user interface. If you have many products to add, you can upload a CSV file containing the Product Master Data for multiple products. See Uploading Product Master Data to learn how. Add a Product to Product Master Data 1. After logging in to TraceLink, Select Master Data Exchange > Product in the Modules menu. Note: The Master Data Exchange menu item displays only if you are a Service Administrator or Member of your company s Master Data Exchange service. You must be a Service Administrator to add or update Master Data. If you do not see this menu item, ask a Company Administrator to add you as a Service Administrator of the Master Data Exchange Service. See Adding Users to the Master Data Exchange Service for details. 2. Click Add Product. Copyright 2017 TraceLink Page 5 10/6/2017

6 3. Enter the fields in the following table. Product Information Fields Field Name / CSV Column Name Product Group Code ProductGroupCode Effective Date EffectiveDate Description Category code your company uses for this product. * Required for all countries. Click the calendar icon and select the effective date for the product. Values Data Status DataStatus Item Status ItemStatus Status of the product in the system. Set to Active to ensure that transaction feeds are successful. * Required for all countries. Production status of the product. * Required for all countries. Active Inactive Released Alternate items available Phase out Items no longer stocked Withdrawn 4. Complete the tabs in the Add Product screen as necessary: Add Item Codes below Add Target Markets on page 8 Add Export Markets on page 13 (only required for India) Add Item Information on page 18 Add Packaging Information on page 22 (not required for US dispensers and organizations performing lot-level operations only) 5. Click Submit. Add Item Codes The Item Codes tab lets you enter one or more item codes for the product. Copyright 2017 TraceLink Page 6 10/6/2017

7 1. Select the Item Codes tab. 2. Enter the fields in the following table. Item Code Fields Field Name / CSV Column Name Item Code Type ItemCodeType Item Code Value ItemCodeValue Primary Item Code ItemCodePrimary Description The item code type your company uses to identify products, for example, Internal Product Code or Country Drug Code. * For products sold into India, you must include the IN Product Code code type. For products exported from India, include both the IN Product Code code type and the Country Drug Code of the destination company. The item code corresponding to the item code type you selected. Indicates whether or not the item code is the primary item code. For uploading using a CSV file, the first item code must be the primary item code. (ItemCodePrimary must be set to Yes.) Values See Item Code Types. Yes No 3. Click the Add New link on the right to specify another item code for the product and select one of the item codes as the Primary Item Code. Copyright 2017 TraceLink Page 7 10/6/2017

8 Specify multiple item codes if your partners use different item code types. For example, for US products, TraceLink recommends that you include a 10-digit item NDC code (for example, US-NDC442) and its corresponding 11-digit NDC code (for example, US-NDC542) to ensure product matches. Include the code types used by trade partners from whom you receive product and ASNs. Add Target Markets The Target Markets tab lets you specify where the product will be sold. 1. Select the Target Markets tab and click the Add New link. 2. Enter the fields in the following table. Copyright 2017 TraceLink Page 8 10/6/2017

9 Target Markets Fields Field Name / CSV Column Name Description Values Country Market Code CountryMarket Product Type CountryMarketProductType Point of Dispense Verification CountryMarketPointofDispenseVerification Country code of the target market. Click the drop-down icon and select a country. You can enter the first few characters of the country to filter the list. Note: The required fields change based on the Country Market Code. Type of product. * Required if Country Market Code is an EU country or TR [Turkey]. Traceability regulations can differ depending on the product type. For example, in the US, over-the-counter drugs do not fall under DSCSA regulations. Indicates whether the target market requires verification when it is dispensed. * Required field if Country Market Code is an EU country. For the US market, enter Not Required. See Country Codes. Derivative Product Medical Device Nutritional Product OTC Drug Prescription Drug Required Not Required Copyright 2017 TraceLink Page 9 10/6/2017

10 Field Name / CSV Column Name Description Values Traceability Required CountryMarketTraceabilityRequired Indicates whether traceability laws apply to the product. * Required field if Country Market Code is US. Set Traceability Required to Required for US products unless a product is exempt from DSCSA traceability, for example, an over-thecounter product or medical device. Required Not Required Copyright 2017 TraceLink Page 10 10/6/2017

11 Field Name / CSV Column Name Description Values Product Origin CountryMarketProductOrigin Indicates the relationship of the purchaser to the originator of the product. Regulatory laws require different data for sales transactions depending on whether a company is the product originator, has purchased directly from the product originator, or has purchased from an intermediary. * Required field if Country Market Code is US. Direct Purchase from Exclusive Distributor: Choose if you are purchasing the product from an exclusive distributor, who purchased from the originator of the product. Direct Purchase from Manufacturer: Choose if you are purchasing the product from a manufacturer, who purchased from the originator of the product. Direct Purchase from Repackager: Choose if you are purchasing the product from a repackager, who purchased from the originator of the product. Indirect Purchase: Select if the company is not purchasing from the originator of the product, but instead, through an intermediary. Originator (Exclusive Distributor): Choose if you are the exclusive distributor, the originator of the product. Originator (Manufacturer): Choose if you are the manufacturer, the originator of the product. Copyright 2017 TraceLink Page 11 10/6/2017

12 Field Name / CSV Column Name Description Values Scheduled Drug CountryMarketScheduledDrug Product Image CountryMarketProductImage Production Type CountryMarketProductionType Manufactured By CountryMarketManufacturedBy MAH ID CountryMarketMAHId CountryMarketMAHIDType Indicates whether the product is a scheduled controlled substance. * Required field if Country Market Code is IN (India). Image file of the product (BMP, GIF, JPT, or PNG). Indicates whether the production is local or not. Type of company doing the manufacturing. * Required field if Country Market Code is IN (India). Company, Company Location, Partner, or Partner Location ID type and value for the Marketing Authorization Holder. * Required field if Country Market Code is an EU country. Yes No Must be either a URL to the image to be retrieved or contains the text "IMAGE SET: [filename]. [mimetype]. The file should be no larger than 10 KB and will be provided in Base64 encoded format for government reporting. Imported Locally Manufactured CMO (Contract Manufacturing Organization) MAH (Marketing Authorization Holder): Brand owner See Identifiers in TraceLink on page 1 Copyright 2017 TraceLink Page 12 10/6/2017

13 Field Name / CSV Column Name Description Values Manufacturing CMO ID CountryMarketManufacturingCMOID CountryMarketManufcaturingCMOIDType Virtual CMO ID CountryMarketVirtualCMOID CountryMarketVirtualCMOIDType Distribution Partner ID(S) DistributionPartnerID DistributionPartnerType Partner Company ID type and value for the Contractor Manufacturing Organization. * Company ID of GCP (GS1 Global Company Prefix) required if Country Market Code is IN (India) and Manufactured By is CMO. Partner Company ID type and value for the virtual Contractor Manufacturing Organization. Partner Company ID type and value for a contracted distributor in the market. You can enter up to five Distribution Partners. See Identifiers in TraceLink on page 1 See Identifiers in TraceLink on page 1. See Identifiers in TraceLink on page 1 3. Click the Add New link on the right to specify another target market for the product. 4. To delete a target market, click the remove icon in the Actions column for a target market. Add Export Markets The Export Markets tab lets you specify the countries from which the product is exported. Note: Complete this tab only if you manufacture or sell in India. Copyright 2017 TraceLink Page 13 10/6/2017

14 1. Select the Export Markets tab. 2. Click the Add New link. 3. Enter the fields in the following table. Export Markets Fields Field Name / CSV Column Name Description Possible Values Export From Country ExportMarketFromCountry Export To Country ExportMarketToCountry Country ISO code of the market from which the product is being exported. If you choose to enter export markets, this field is required. Country ISO code of the market to which the product is being exported. * Required field if Export From Country is IN (India). See Country Codes on page 1. See Country Codes on page 1. Copyright 2017 TraceLink Page 14 10/6/2017

15 Field Name / CSV Column Name Description Possible Values Unit Price Unit price of the product. ExportMarketUnitPrice Currency Code ExportMarketUnitPriceCurrencyCode Manufactured By ExportMarketManufacturedBy Manufacturer ID Type ExportMarketManufacturerIDType Currency code of the product. * Required field if you enter a value for Unit Price. Indicates whether the company manufacturers the product itself (MAH) or whether another company manufactures or packages the product (CMO). * Required field if Export From Country is IN (India). Company ID type used to specify the manufacturer. * Company ID Type of GCP (GS1 Global Company Prefix) required if Export From Country is IN (India) and Manufactured By is CMO. See Currency Codes on page 1 CMO: Contract Manufacturing Organization or Contract Packaging Organization MAH: Marketing Authorization Holder (brand owner) See Identifiers in TraceLink on page 1 Copyright 2017 TraceLink Page 15 10/6/2017

16 Field Name / CSV Column Name Description Possible Values Manufacturer ID ExportMarketManufacturerID Target Market Exemption ExportMarketTargetMarketExemption Company ID for the manufacturer. * Required field if Country Market Code is In (India) and Language Code is English. * Company ID Type of GCP (GS1 Global Company Prefix) required if Export From Country is IN (India) and Manufactured By is CMO. Indicates whether there is a target market exemption. * Required field if Export From Country is IN (India). See Identifiers in TraceLink on page 1 True False Defaults to False. Copyright 2017 TraceLink Page 16 10/6/2017

17 Field Name / CSV Column Name Description Possible Values Export Country Exemption Code ExportMarketExportCountryExemptionCode Exemption Reference ExportMarketTargetMarketExemptionReference Exemption Date ExportMarketTargetMarketExemptionDate Exemption code for the export country. * Required field if Export From Country is IN (India) and the Target Market Exemption is True. Target market exemption reference. * Required field if Export From Country is IN (India) and the Target Market Exemption is True. Target market exemption date. * Required field if Export From Country is IN (India) and the Target Market Exemption is True. IN-Consignment: Indicates consignments containing drugs or devices for export purposes to countries eligible for exemption from barcoding as per rule 21 of Drugs and Cosmetic Act with specific notification number. IN-Merchant Consignment: Indicates merchant exporter s consignment containing drugs or devices from multiple manufacturers. IN-Manufacturer: Indicates drugs or devices having barcoding requirements as defined by the importing country. Copyright 2017 TraceLink Page 17 10/6/2017

18 4. Click the Add New link on the right to specify additional export markets. 5. To delete an export market row, click the remove icon in the Actions column. Add Item Information In the Item Information tab, you specify product information for the languages in the markets where the item is sold. You can add item information for multiple languages. When a user selects a particular display language (by selecting Application Settings > General in the top right), the item information for that language displays where applicable. Complete the Item Information tab for each language in the markets where the item is sold. 1. Select the Item Information tab. 2. Enter the fields in the following table. Copyright 2017 TraceLink Page 18 10/6/2017

19 Item Information Fields Field Name / CSV Column Name Description Values Language Code ItemInfoLanguageCode Product Description ItemInfoProductDescription Product Code ItemInfoProductCode Product Name ItemInfoDrugName The language in which the item information is defined. * Must include English for US, IN [India] and EU countries. * Must include Korean for KR [Korea, Republic of]. * Must include Portuguese for BR [Brazil]. * Must include Simplified Chinese for CN [China]. A description that typically includes the product name and strength * Required for all countries. A company-specific code for the product. * Required field if the Language Code is Simplified Chinese. The name of the product. * Required for all countries. Arabic English French German Italian Japanese Korean Spanish Polish Portuguese Simplified Chinese Turkish Copyright 2017 TraceLink Page 19 10/6/2017

20 Field Name / CSV Column Name Description Values Generic Name ItemInfoGenericName The generic (non-proprietary) item name. * Required field if the Target Markets tab includes US (United States). You add a target market by using the Country Market Code on the Target Markets tab. * Required field if the Target Markets tab includes IN [India] and the Language Code is English. Manufacturer ItemInfoManufacturer Manufacturer ID ItemInfoManufacturerId Strength ItemInfoStrength The company name of the manufacturer. * Required for all countries. The manufacturing company ID. Specify the strength of product, for example, 20MG. * Required field if the Target Markets tab includes US (United States). * Required field if the Target Markets tab includes an EU country and the Language Code is English. * Required field if the Target Markets tab includes China and the Language Code is Simplified Chinese. See Identifiers in TraceLink. Drug Composition ItemInfoComposition Composition of the drug. * Required field if the Target Markets tab includes IN [India] and Language Code is English. Maximum of 500 characters. Copyright 2017 TraceLink Page 20 10/6/2017

21 Field Name / CSV Column Name Description Values Dosage Form ItemInfoDosageForm The unit dose of the product, for example, tablet, capsule, syrup. EMVS Dosage Form ItemInfoEMVSDosageForm EMVS German Dosage Form ItemInfoEMVSGermanDosageForm * Required field if the Target Markets tab includes US and the Language Code is English and the Product Type is not Medical Device, OTC Drug, Nutritional Product, or Derivative Product. The unit dose of the product using the dosage forms provided by EMVS (European Medicines Verification System). * Required field if the Target Markets tab includes EU countries and the Language Code is English. The unit dose specified in the dosage formats provided by EMVS (European Medicines Verification System). These values are in German. * Required field if the Target Markets tab includes DE [Germany]. For valid values, see the drop down list in the User Interface (UI). For valid values, see the drop down list in the User Interface (UI). Copyright 2017 TraceLink Page 21 10/6/2017

22 Field Name / CSV Column Name Description Values Package Size / Spec ItemInfoPackageSize The number of units in a package. * Required if the Language Code is Korean. EMVS Pack Code ItemInfoEMVSPackCode Remarks ItemInfoRemarks * Required field if the Target Markets tab includes US and the Language Code is English and the Product Type is not Medical Device, OTC Drug, Nutritional Product, or Derivative Product. * Required field if the Target Markets tab includes CN [China] and the Language Code is Simplified Chinese. * Required field if the Target Markets tab includes EU countries and the Language Code is English. The packaging type for the product. EMVS Pack Code contains all codes provided by the EU. * Required field if the Target Markets tab includes EU countries and the Language Code is English. Optional remarks about the product. For valid values, see the drop down list in the User Interface (UI). 3. Click the Add New link on the right to specify item information for another language. 4. To delete an item information row, click the remove icon in the Actions column. Add Packaging Information The Packaging Information tab lets you enter packaging and serialization specifications for each packaging level for the product. Copyright 2017 TraceLink Page 22 10/6/2017

23 Note: Packaging information is not required for lot-level traceability. 1. Select the Packaging Information tab. 2. Click the Add New link on the right and complete the fields described in the following table. The fields available may vary depending on the Packaging Code Type you select in the first column of the table. Packaging Information Fields Note: To track lot-level operations, you do not need to complete the Packaging Information fields. Complete these fields only if you are tracking serialized operations. Copyright 2017 TraceLink Page 23 10/6/2017

24 Field Name / CSV Column Name Description Values Packaging Code Type PackagingCodeType Packaging Code PackagingCode The packaging code type used to specify the packaging code. Select what s appropriate for the locale where you are selling the product and for the packaging level. When you select a packaging code type, the fields required for that code type are displayed. * If you use the Packaging Information tab, the Packaging Code Type field is required. The value for the selected Packaging Code Type. See Serial Number Packaging Codes. GTIN-12 GTIN-13 GTIN-14 NTIN CN-ResCode Copyright 2017 TraceLink Page 24 10/6/2017

25 Field Name / CSV Column Name Description Values Packaging UOM PackagingUOM Container Aggregation Quantity PackagingContainerAggregationQty A unit of measure for the item depending on the Packaging Code Type you entered. * If you use the Packaging Information tab, the Packaging UOM field is required. Note: India manufacturers and exporters specify the primary packaging level; however, India s export regulations do not require manufacturers or exporters to serialize primary level units. India s domestic pharmaceutical regulations that are currently under development will require primary level units to be serialized. The number of child units for this packaging level. For example, enter 16 for the carton level if it contains 16 of its (inner pack) child unit. * Required when the Target Markets tab includes IN (India). For India, you must include the number of primary packs in the each packaging level in the Container Aggregation Quantity field. For CN-ResCode: Each InnerPack/Bundle Case/Shipper None For other Packaging Code Types: Primary: The level below the saleable unit the product packaging that is in direct contact with the drug product) Specify the Primary packaging level using GTIN-14s. Each Inner Pack/Bundle Case/Shipper Pallet Copyright 2017 TraceLink Page 25 10/6/2017

26 Field Name / CSV Column Name Description Values Packaging Ratio PackagingRatio Batch Size Max / Acceptable / Min BatchSizeMaximum AcceptableYield MinimumYield Serialization Type PackagingSerializationType Requires Aggregation PackagingRequiresAggregation Filter Value PackagingFilterValue A ratio of the number of units in each packaging level. For example, if an inner pack is made of 12 eaches and a case is made of 16 inner packs, the Packaging Ratio is: 1:16:192. Thus a case contains 192 eaches. Batch threshold parameters that can be assigned for the Each unit of measure. * Batch Size Max required if Acceptable Yield or Minimum Yield Percentage are entered. Indicates the order in which TraceLink will generate serial numbers. Indicates whether the product will be configured for aggregation when serialized. A value 0-7 sometimes used to represent a packaging level. Your company defines which values correspond to which packaging levels. For example, you might use 0 for eaches, 1 for cases, and so on. * Required field for GTIN- 14 Max is an integer. Acceptable and Min are percentages. None Random Sequential Aggregated Not Aggregated 0-7 Copyright 2017 TraceLink Page 26 10/6/2017

27 Field Name / CSV Column Name Description Values GS1 Company Prefix PackagingGS1CompanyPrefix Code Version / Code Level PackagingCodeVersion PackagingCodeLevel Data Status PackagingDataStatus Your company s GS1 Company Prefix. * Required field for GTIN- 13, GTIN-14, NTIN A code version and code level. * Required field if Packaging Code Type is CN-ResCode. Enter Active if the product is currently being sold; otherwise, enter Inactive. Active Inactive 3. To add additional packaging levels, click the Add New link on the right. 4. To delete a packaging information row, click the remove icon in the Actions column. Updating Products To update existing products, you'll need to search for the products in Product Master Data. Update a Product To update a Product's Master Data: 1. Select Master Data Exchange > Product in the Modules menu. By default, no products display in the list. You must set Search Criteria to view products. 2. Ensure that the Search Criteria section of the page is expanded. Click the expand icon if necessary. Tip: Enter a wildcard (*) and click Search to list all products in Product Master Data. 3. To search for: All products in your company's Master Data, keep all search criteria defaults, but add the wildcard (*) character in the Product Description field. Click Search. A particular product, select the Item Code Type you're using for the search, enter the Item Code. Click Search. Copyright 2017 TraceLink Page 27 10/6/2017

28 The item or items display in the list. 4. Click the View Details link for the product you want to update. 5. Click Edit Product Details. 6. Update the product information 7. Click Submit. Accessing Product Master Data To view Product Master Data, you must be a Service Member of the Master Data Exchange service. You ll need someone who is a Service Administrator of the Master Data Exchange service to assign you this role. Search for Products To search for a product in Product Master Data: 1. Select Master Data Exchange > Product in the Modules menu. By default, no products display in the list. You must set Search Criteria to view products. 2. Ensure that the Search Criteria section of the page is expanded. Click the expand icon if necessary. Tip: Enter a wildcard (*) and click Search to list all products in Product Master Data. 3. To filter the list, you can set any of the following criteria: Criteria Item Code Type / Item Code Packaging Code Type / Packaging Code Data status Description Select the product s code type from the Item Code Type list. Then, enter the product s code in the Item Code field that is enabled. Select the product s packaging code type from the Packaging Code Type list. Then, enter the product s packaging code in the Packaging Code field that is enabled. Set Data Status to All to view active and inactive partner companies and locations, or filter by just the Active or Inactive companies and locations. Copyright 2017 TraceLink Page 28 10/6/2017

29 Criteria Product Group Code Product Description Description Enter the category code your company uses for this product. Filter the list by entering text from the Product Description field. Enter a wildcard (*) to list all products. 4. Click Search. 5. Click the View Details link in the Actions column for the product you want to view. Exporting Product Master Data You can export Product Master Data to a CSV file for all products or for a filtered list of products. If you want to add new products to TraceLink, you can export all Product Master Data to a CSV file, add the new Product Master Data to the file, then upload it. To upload Product Master Data using a CSV file, see Uploading Products. Export Product Master Data To save Product Master Data to a CSV file: 1. Select Master Data Exchange > Product in the Modules menu. 2. To filter the list to be exported, enter Search Criteria. 3. Click Search. 4. Export the data: To export data for the filtered list of products, click the Export Filtered Product Data to CSV link. To export data for all products, click the Export All Product Data to CSV link. TraceLink downloads the CSV file. Copyright 2017 TraceLink Page 29 10/6/2017

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