Add product master data

Products must exist in Product Information Manager before serial number information can be synced so that the downstream supply chain can verify against these products.

Only Producers can add product master data.

Add product master data to sync to Product Information Manager

Producers must add product master data to Master Data Exchange so that TraceLink can sync these product entries to Product Information Manager. The data rules determine which products are synced and whether the products are available for verification or download to the downstream supply chain.

  1. Hover over Master Data Exchange in the Modules drop-down at the top of the screen, and then select Product Master Data.
  2. Select Add Product.
  3. In the Product Information section:
    1. Enter an internal code defined by the user's company that identifies products in the same product classification (e.g. group code for all products related to oncology) in the Product Group Code field (optional).

      The View Product Master Data screen uses this code to search for all products in the same classification entered into Product Master Data.

    2. Enter the Effective Date for the product (optional).
    3. Select Active as the Data Status.
    4. Select Released as the Item Status.
  4. On the Item Codes tab:
    1. Select an Item Code Type from the drop-down.

      Must include at least one NDC-442, NDC-532, NDC-541, or NDC-542.

    2. Enter the Item Code Value in the text field.
    3. Select Add New, and repeat the previous steps to add another identifier (optional).
    4. Select a Primary Identifier if there is more than one identifier (minimum one identifier required).
  5. On the Target Markets tabs:
    1. Select Add New.
    2. Enter the 2-letter ISO 3166-1alpha-2:1997 Country Market Code.

      Must include a target market that is also defined for syncing on the Product Information Manager Data Rules screen in Management.

      At least one Target Market is required. All fields are optional by default. See Country Requirements below for mandatory fields determined by the Country Market Code selected.

    3. Select the Product Type from the drop-down (for informational purposes only, not compliance reporting):
      • Bulk Pharmaceutical – A product that is the main active ingredient in one or more pharmaceutical formulas (e.g. antibiotics).
      • Derivative Product – A product derived from another chemical compound.
      • Medical Device – A device developed and used for a medical purpose.
      • Nutritional Product – A specific class of over-the-counter product use for health and nutrition benefit.
      • OTC Drug – A medicine available over the counter.
      • Prescription Drug – A medicine available by prescription only.

    4. Select the type medicine that a product is registered as from the Registration Classification drop-down (optional):

      • Biological – A medicine that is manufactured in a living system such as a microorganism, or plant or animal cells.
      • Chemical – A medicine that is typically manufactured through chemical synthesis.
      • Patent Medicine – A traditional or herbal medicine with a standardized formula that is packaged into pill or tablet form and sold over the counter.
    5. Select the product's medicinal classification from the Prescription Drug Type drop-down (optional).
    6. Enter the product's Marketing Authorization Number issued by a government agency.
    7. Select whether the product requires verification at or just prior to the dispensation to a patient from the Point of Dispense Verification drop-down (optional):
      • Not Required – Verification is not required at or just prior to dispensation to a patient.
      • Required – Verification is required at or just prior to dispensation to a patient.
    8. Select whether the Target Market legally requires the product to be tracked through the pharmaceutical supply chain from the Traceability Required drop-down:
      • Not Required – The product is exempt from tracking.
      • Required – The product requires tracking.
    9. Select how the company acquired the product from the Product Origin drop-down:
      • Direct Purchase from Exclusive Distributor – The company purchased the product from the sole distributor of the product.
      • Direct Purchase from Manufacturer – The company purchased the product from the manufacturer.
      • Direct Purchase from Repackager – The company purchased the product from a repackager.
      • Indirect Purchase – The company purchased the product from a wholesale distributor.
      • Originator (Exclusive Distributor) – The company, as a wholesale distributor, directly purchased the product from the manufacturer and serves as the sole distributor of the product. This option only applies if the Country Market Code is United States.
      • Originator (Manufacturer) – The company manufactures the product.
    10. Select whether the product is classified in one of the schedules assigned to controlled substances from the Scheduled Drug drop-down (optional):
      • Yes – The target market considers the product a scheduled drug.
      • No – The target market does not consider the product a scheduled drug.
    11. Enter the Medicinal Product Package Identifier (PCID) that determines the EU Hub's Article 57 Code on Master Data Compliance Reports in the PCID field (optional).
    12. Enter the commodity tariff code that classifies the product when determining its customs value in the Product Category Identifier field (optional).
    13. Select the Reporting Item Code type that is used in this Target Market instead of the Target Market's default item code for compliance reporting, and enter the identifier value in the field (optional, must not already be entered on the Item Codes tab).
    14. Select Choose File to import a BMP, GIF, JPG, or PNG Product Image displaying the product's appearance or packaging, with a maximum size of 10KB (optional).
    15. Select where the product is manufactured relative to the country defined in the Target Market from the Production Type drop-down (optional):
      • Imported – The company manufactures the product outside the target market.
      • Imported and Repackaged Locally – The company manufactures the product outside of the target market but packages it in the target market.
      • Locally Manufactured – The company manufactures the product in the target market.
    16. Select the type of organization that the product is Manufactured By (optional):
      • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
      • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
    17. Select the MAH ID type from the drop-down, and enter the value in the field.

      Must be a GLN, and the identifier must exist in Company Master Data.

    18. Enter the Internal Material Code used by the MAH in the MAH Internal Material Code field (optional).
    19. Select the Manufacturing CMO ID type from the drop-down, and enter the value in the field (optional).
    20. Enter the Internal Material Code used by the CMO that manufactured the product in the CMO Internal Material Code field (optional).
    21. Select the identifier type for the third party contracted to oversee the CMO from the Virtual CMO ID drop-down, and enter the value in the field (optional).
    22. Enter the Internal Material Code used by the Virtual CMO that manufactured the product in the VCMO Internal Material Code field (optional).
    23. Enter the license number granted to import the product into this Target Market permanently in the License for Permanent Import field (optional).
    24. Enter the date on which the License for Permanent Import expires in the License for Permanent Import End Date field (optional).
    25. Enter the license number granted to import the product into this Target Market temporarily before it is re-exported in the License for Temporary Import field (optional).
    26. Enter the date on which the License for Temporary Import expires in the License for Temporary Import End Date field (optional).
    27. Select the identifier type for the company that is importing the product into this Target Market from the Importer ID drop-down, and enter the value in the field (optional).
    28. Enter the license number granted to repackage product in the License for Permanent Import field (optional).
    29. Enter the date on which the Repackaging License Number expires in the Repackaging License Number End Date field (optional).
    30. Select the identifier type for the company that repackages the product from the Repackager ID drop-down, and enter the value in the field (optional).
    31. Select the identifier type for the Partner company or internal location that the MAH uses to distribute the product in the Target Market from the Distribution Partner IDs drop-down, and enter the value in the field (optional).
    32. Repeat the previous step to add additional Distribution Partner IDs (limit of 10 identifiers in the user interface and 100 identifiers in the CSV import per Target Market).
    33. Select Add New and repeat the previous steps to add another Target Market.
  6. On the Export Markets tab (optional):
    1. Select Add New.
    2. Enter the 2-letter ISO 3166-1alpha-2:1997 Country Code for the country that the company exports the product from in the Export From Country field (optional).

      All fields are optional by default. See Country Requirements below for mandatory fields determined by the Country Market Code selected.

    3. Enter the country that the company exports the product to in the Export to Country field (optional).
    4. Enter the Unit Price that each individual unit of the product sells for in the export market (optional).

      Values must be 0.50 – 9999999.99 if the Export to Country Code field is set to India (IN).

    5. Enter the Currency Code for the export market (required if Unit Price is present).
    6. Select the type of organization that the product is Manufactured By (optional):
      • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
      • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
    7. Select the Manufacturer ID Type from the drop-down (optional).
    8. Enter the Manufacturer ID value (required if a Manufacturer ID Type is selected).
    9. Select whether the product is exempt from regulatory compliance in the Export To Country from the Target Market Exemption drop-down (optional):
      • True – The product is exempt from the export market's regulatory compliance.
      • False – The product is not exempt from the export market's regulatory compliance.
    10. Select the reason for the product's exemption from the Export Country Exemption Code drop-down (optional):
      • IN - Consignment – Consignments that contain products for export to countries that are eligible for exemption from India's bar-coding law.
      • IN - Manufacturer – Products that need bar-coding for the import countries' bar-coding requirements, rather than India's.
    11. Enter the Exemption Reference to the serialization or compliance exemption granted by the government (optional).
    12. Enter the Exemption Date that the government granted the exemption on (optional).
    13. Select Add New and repeat the previous steps to add another export market.
  7. On the Item Information tab:
    1. Select English as the Language Code for the item information.

      Only one English item information can be defined. If more than one English item information is defined, TraceLink does not sync the product entry to Product Information Manager.

    2. Enter a Product Description, e.g. the product name, dosage, form, and the number of doses.
    3. Enter the regulatory Product Code associated with the product in China or an additional Product Code for other Target Markets (optional).
    4. Enter the Product Name.
    5. Enter the chemical Generic Name of the product.
    6. Enter the name of the Manufacturer or repackager as it appears on the product label.
    7. Enter the Manufacturer ID entered in Partner or Company Master Data (optional).
    8. Enter the Strength of the product, e.g. 100 mg.
    9. Enter the chemical Drug Composition of the product (optional).
    10. Enter the Dosage Form that the product is dispensed in, e.g. tablet or pill.
    11. Enter the EMVS Dosage Form that the product is dispensed in according to the EU's standard set of values (optional).
    12. Enter the Market Dosage Form that the product is dispensed in according to this Target Market's set of values (optional).
    13. Enter the number of individual doses in the pack in the Package Size/Spec field.
    14. Enter the EMVS Pack Code to indicate how the product is packaged to be sold according to the EU's standard set of values (optional).
    15. Enter product-related instructions or comments not described in the previous fields in the Remarks field (optional).
    16. Enter the coldest temperature the product can be exposed without compromising its quality and safety in the Minimum Temperature field (optional). If both the Minimum Temperature and Maximum Temperature are present, the Minimum Temperature must be less than or equal to the Maximum Temperature.
    17. Enter the hottest temperature the product can be exposed without compromising its quality and safety in the Maximum Temperature field (optional). If both the Minimum Temperature and Maximum Temperature are present, the Maximum Temperature must be greater than or equal to the Minimum Temperature.

    18. Select the Temperature Scale that the Minimum Temperature and Maximum Temperature are entered in (required if either Maximum Temperature or Maximum Temperature are present):

      • Celsius
      • Fahrenheit
      • Kelvin

    19. Specify whether exposure to light can compromise the product's quality and safety Sensitive to Light? drop-down (optional):

      • Yes – Exposure to light can compromise the product's quality and safety.
      • No – Exposure to light does not compromise the product's quality and safety.
    20. Enter the length of time that the product remains consumable for in the Shelf Life field (optional). Value entered must be a number between 1-9999.

    21. Select the unit of time in which the Shelf Life is entered in the Unit of Time drop-down (required if Shelf Life is present):

      • Days (default)
      • Months
      • Years
    22. Select Add New and repeat the previous steps to add Item Information in another language.
  8. On the Packaging Information tab:
    1. Select Add New.
    2. Select the Packaging Code Type used to generate serial numbers for the product:
      • CN-ResCode – This packaging code type is specific to China (must be 5 digits).
      • GTIN-14 – (Global Trade Item Number) This packaging code type is accepted in any country (must be 14 digits).
      • NTIN – (National Trade Item Number) This packaging code type is specific to a single country (must be 14 digits).
    3. Select GTIN-14 as the Packaging Code Type used to generate serial numbers for the product.
    4. Enter the Packaging Code value in the field below the drop-down.

      or

      Enter the Subtype-Rescode if the Packaging Code Type is CN-Rescode.

    5. Select Each as the Packaging UOM (unit of measure) for this packaging code.
    6. Enter 0 as the Container Aggregation Quantity, which indicates that the eaches do not contain any children.
    7. Enter the Packaging Ratio of the levels included within this packaging code, e.g. 1:5:10 refers to one large Case, with 5 smaller Inner Packs/Bundles inside, which each have a total of 10 Eaches (required if the Packaging Code Type is CN-ResCode, for compliance reporting purposes only, not validation during aggregation)(optional for informational purposes only, not validation during aggregation).
    8. Enter the Batch Size Max/Acceptable/Min parameters, which are necessary for Serial Number Exchange to perform End of Batch Verification and generate Documents of Serialization (optional, and displays only when the Packaging UOM is Each):
      1. Enter the Batch Size Max in the first text field (optional).

      2. Enter the Acceptable size of the batch, using a percentage, in the middle text field (required if the Batch Size Max is present).

      3. Enter the Minimum acceptable size of the batch, using a percentage, in the last text field (required if the Batch Size Max is present).

    9. Select the type of pattern used to generate serial numbers from the Serialization Type drop-down (optional for informational purposes only, not validation during aggregation):
      • None – The packaging code does not generate serial numbers.
      • Random – The pattern generates serial numbers at random.
      • Sequential –The pattern generates serial numbers in sequential order.
    10. Select whether each UOM Requires Aggregation (optional for informational purposes only, not validation during aggregation):
      • Aggregated – Each UOM requires serial numbers.
      • Not Aggregated – Not every UOM requires serial numbers.
    11. Enter the Filter Value that allows an RFID reader to select only the packaging code for this packaging level, out of many other levels of packaging codes, with only numeric values from 0-7 (optional).
    12. Enter the GS1 Company Prefix included in the Packaging Code, assigned by the GS1 organization, must be a numeric value 4 to 7 characters long. This includes the FDA-assigned labeler code.
    13. Enter the product Code Version number, e.g. 81, 88 (required if the Packaging Code Type is CN-ResCode)(optional).
    14. Enter the packaging Code Level associated with this ResCode, with only numeric values 1-9 allowed where 1 is the innermost packaging level (required if the Packaging Code Type is CN-ResCode)(optional).
    15. Select a Data Status from the drop-down:
      • Active – The data can be used in messages and UI functions, and TraceLink pulls the data when necessary.
      • Inactive – The data cannot be pulled for other functions within TraceLink.
    16. Select Add New and repeat the previous steps to add another packaging code for a different UOM. TraceLink syncs other Packaging UOMs (except for Primary) that have a Container Aggregation Quantity defined to Product Information Manager, as long as an Each is defined with a Container Aggregation Quantity of 0.

      Only one Packaging Code for each Packaging UOM can be defined. If more than one packaging code is defined for the same packaging UOM, TraceLink does not sync the product entry to Product Information Manager.

  9. Select Submit.

    The View Product Master Data screen displays, and the new product displays in the results table.

Tips:

  1. Hover over Master Data Exchange in the Modules drop-down at the top of the screen, and then select Product Master Data.
  2. Select the Import icon in the top-right.
  3. Select Choose File.
  4. Browse for and select the desired CSV file (see Formatting the CSV for more information).

    The element headers below are all required in the CSV file, in order, and separated by commas.

    • ProductGroupCode – An internal code defined by the user's company that identifies products in the same product classification, e.g. group code for all products related to oncology (value optional). The View Product Master Data screen uses this code to search for all products in the same classification entered into Product Master Data.
    • ItemStatus – The product's commercial status. Must be Released to sync the product entry to Product Information Manager.
    • DataStatus – Whether the product data is active within TraceLink. Must be Active to sync the product entry to Product Information Manager.
    • EffectiveDate – The date that the product master data takes effect (value optional).
    • ItemCodeType – The unique item code that identifies this product. Products require an item code for every target market. Each item code type can only be used once for each product, except for Internal Material Number. Must include at least one NDC-442, NDC-532, NDC-541, or NDC-542 to sync the product entry to Product Information Manager.
    • ItemCodeValue – The value of the ItemCodeType. The value must be unique within the ItemCodeType, and special characters (e.g. -, ., /. \) are removed from this value.
    • ItemCodePrimary – Indicate the primary item code used by this company by entering Yes. TraceLink uses the primary item code to identify the correct product when the user updates the product master data by importing a CSV file or with an asynchronous message.
    • CountryMarket – Two-letter ISO 3166-1alpha-2:1997 Country Code of the Target Market's country. Must include a target market that is also defined for syncing on the Product Information Manager Data Rules screen in Management to sync the product entry.

      At least one Target Market is required. All fields are optional by default. See Edit Product for country requirements.

    • CountryMarketProductType – Type of product.
      • Bulk Pharmaceutical – A product that is the main active ingredient in one or more pharmaceutical formulas (e.g. antibiotics).
      • Derivative Product – A product derived from another chemical compound.
      • Medical Device – A device developed and used for a medical purpose.
      • Nutritional Product – A specific class of over-the-counter product use for health and nutrition benefit.
      • OTC Drug – A medicine available over the counter.
      • Prescription Drug – A medicine available by prescription only.
    • CountryMarketPointOfDispenseVerification – Whether or not the product requires verification at or just prior to the dispensation to a patient (value optional).
      • Not Required – Verification is not required at or just prior to dispensation to a patient.
      • Required – Verification is required at or just prior to dispensation to a patient.
    • CountryMarketTraceabilityRequired – Indicates whether the product legally needs to be traced through the pharmaceutical supply chain.
    • CountryMarketProductOrigin – How the company acquires the product.
      • Direct Purchase from Exclusive Distributor – The company purchased the product from the sole distributor of the product.
      • Direct Purchase from Manufacturer – The company purchased the product from the manufacturer.
      • Direct Purchase from Repackager – The company purchased the product from a repackager.
      • Indirect Purchase – The company purchased the product from a wholesale distributor.
      • Originator (Exclusive Distributor) – The company, as a wholesale distributor, directly purchased the product from the manufacturer and serves as the sole distributor of the product. This option only applies if the CountryMarket is United States.
      • Originator (Manufacturer) – The company manufactures the product.
    • CountryMarketScheduledDrug – Indicates whether the product is classified in one of the schedules assigned to controlled substances (value optional).
      • Yes – The target market considers the product a scheduled drug.
      • No – The target market does not consider the product a scheduled drug.
    • CountryMarketProductImage – Image file displaying the product's appearance or packaging. The View Product Details screen displays the image, and reports for some compliance organizations might include the image (value optional).
    • CountryMarketManufacturedBy – The type of organization manufacturing the product (value optional).
      • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
      • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
    • CountryMarketPCID – Medicinal Product Package Identifier (PCID) determines the EU Hub's Article 57 Code on Master Data Compliance Reports (value optional).
    • CountryMarketProductCategoryIdentifier – The commodity tariff code that classifies the product when determining its customs value (value optional).
    • CountryMarketReportingItemCode – The product's Item Code that is used in a specific Target Market instead of the Target Markets default Item Code for compliance reporting (value optional).
    • CountryMarketReportingItemCodeType – The type of item code used for the CountryMarketReportingItemCode (value required if CountryMarketReportingItemCode is present).
    • CountryMarketProductionType – Where the product is manufactured relative to the country defined in the Target Market (value optional).
      • Imported – The company manufactures the product outside the target market.
      • Imported and Repackaged Locally – The company manufactures the product outside of the target market but packages it in the target market.
      • Locally Manufactured – The company manufactures the product in the target market.
    • CountryMarketMAHId – The company or location identifier of the MAH, which must exist in Company or Partner Master Data.
    • CountryMarketMAHIdType – The type of identifier used for the CountryMarketMAHId.

      Must be a GLN and the identifier must exist in Company Master Data to sync the product entry to Product Information Manager.

    • CountryMarketMAHInternalMaterialCode – The Internal Material Code used by the MAH for the product (value optional).
    • CountryMarketManufacturingCMOId – The company ID for the CMO manufacturing the product (value optional).
    • CountryMarketManufacturingCMOIdType – The type of identifier used for the CountryMarketManufacturingCMOId (required if CountryMarketManufacturingCMOId is present).
    • CountryMarketCMOInternalMaterialCode – The Internal Material Code used by the CMO that manufactured the product (value optional).
    • CountryMarketVirtualCMOId – The identifier for a third-party contracted to oversee the CMO (value optional).
    • CountryMarketVirtualCMOIdType – The type of identifier used for the CountryMarketVirtualCMOId (required if CountryMarketVirtualCMOId is present).
    • CountryMarketVCMOInternalMaterialCode – The Internal Material Code used by the Virtual CMO for the product (value optional).
    • DistributionPartnerID – The trade partner companies or internal locations that the MAH uses to distribute the product in the Target Market (e.g. 3PL). This company must exist in Partner Master Data or as a location in Company Master Data (value optional). Limit of 100 identifiers in the CSV import per target market.
    • DistributionPartnerType – The type of identifier used for the DistributionPartnerID (required if DistributionPartnerID present).
    • ExportMarketFromCountry – Two-letter ISO 3166-1alpha-2:1997 Country Code for the country that the company exports the product from (value optional).
    • ExportMarketToCountry – Two-letter ISO 3166-1alpha-2:1997 Country Code of the country that the company exports the product to (value optional).
    • ExportMarketUnitPrice – The price that each unit of the product sells for (value optional).
    • ExportMarketUnitPriceCurrencyCode – The currency code for the product's ExportMarketUnitPrice (value optional).
    • ExportMarketTargetMarketExemption – Indicates whether the product is exempt from regulatory compliance in the ExportMarketToCountry (value optional).
      • True – The product is exempt from the export market's regulatory compliance.
      • False – The product is not exempt from the export market's regulatory compliance.
    • ExportMarketExportCountryExemptionCode – The reason for the product's exemption, specific to India (value optional).
      • IN - Consignment – Consignments that contain products for export to countries that are eligible for exemption from India's bar-coding law.
      • IN - Manufacturer – Products that need bar-coding for the import countries' bar-coding requirements, rather than India's.
    • ExportMarketTargetMarketExemptionReference – The reference to the serialization or compliance exemption granted by the government (value optional).
    • ExportMarketTargetMarketExemptionDate – The date that the government granted the exemption (value optional).
    • ExportMarketManufacturedBy – The type of organization manufacturing the product (value optional).
      • MAH – (Marketing Authorization Holder) The company registered as the product's marketing authorization holder for this export market.
      • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this export market.
    • ExportMarketManufacturerId – The unique value associated with the MAH or CMO (value optional).
    • ExportMarketManufacturerIdType – The type of identifier used for the ExportMarketManufacturerId (required if ExportMarketManufacturerId is present).
    • ItemInfoLanguageCode – Language for the item information.

      Must be English to sync the product entry to Product Information Manager. Only one English item information can be defined. If more than one English item information is defined, TraceLink does not sync the product entry to Product Information Manager.

    • ItemInfoProductDescription – Typically includes the product name, dosage, form, and the number of doses.
    • ItemInfoComposition – The chemical composition of the product (value optional).
    • ItemInfoRemarks – Product-related instructions or comments not described in the previous fields (value optional).
    • ItemInfoProductCode – Regulatory product code associated with the product in China, or an additional product code in other Target Markets (value optional).
    • ItemInfoDrugName – The name of the product.
    • ItemInfoGenericName – The chemical or non-proprietary name of the product.
    • ItemInfoManufacturer – The name of the manufacturer or re-packager as it appears on the product label.
    • ItemInfoManufacturerId – The Manufacturer's ID, which must be entered into the Partner or Company Master Data to populate in the type-ahead field (value optional).
    • ItemInfoStrength – The strength of the product, e.g. 100 mg.
    • ItemInfoDosageForm – The form the product is dispensed in, e.g. tablet or pill.
    • ItemInfoEMVSDosageForm – The form the product is dispensed in according to the EU's standard set of values (value optional).
    • ItemInfoPackageSize – The number of individual doses in the pack.
    • ItemInfoEMVSPackCode – The way the product is packaged to be sold according to the EU's standard set of values (value optional).
    • PackagingCodeType – The serial numbers for the product are generated according to the packaging code type. If necessary, define a packaging code for each packaging unit of measure that needs to be tracked. Must be GTIN-14 to sync the product entry to Product Information Manager.
      • CN-ResCode – This packaging code type is specific to China (must be 5 digits).
      • GTIN-14 – (Global Trade Item Number) This packaging code type is accepted in any country (must be 14 digits).
      • NTIN – (National Trade Item Number) This packaging code type is specific to a single country (must be 14 digits).
    • PackagingCode – The unique value of the PackagingCodeType.
    • PackagingUOM – (Packaging Unit of Measure) Determines the level of the packaging hierarchy for this packaging code. If multiple packaging codes are defined, serial numbers can be generated for each level of the packaging hierarchy.
      • Primary – The level of packaging that physically touches the product, i.e. blister packs (not available for CN-ResCodes).
      • Each – The smallest salable unit of the product.
      • Inner Pack/Bundle – A grouping of eaches.
      • Case/Shipper – A grouping of inner packs/bundles or a grouping of eaches if the packaging hierarchy does not include inner packs/bundles.
      • Pallet – The level of packaging with cases grouped together on a pallet (not available for CN-ResCodes).
      • None – Available only for CN-Rescodes.

      One Each must be defined if the Owner needs to sync the product entry to Product Information Manager. Only one PackagingCode for each PackagingUOM can be defined. If more than one packaging code is defined for the same packaging UOM, TraceLink does not sync the product entry to Product Information Manager. TraceLink also does not sync Primary packaging codes.

    • PackagingContainerAggregationQty – Number of children contained in this level of shipment. E.g. for a Case, the PackagingContainerAggregationQty would list the number of Inner Packs contained in each Case.

      Must be 0 for eaches if the Owner needs to sync the product entry to Product Information Manager. TraceLink also syncs other packaging UOMs that have a PackagingContainerAggregationQty set, as long as an each is defined with a PackagingContainerAggregationQty of 0.

    • PackagingRatio – The ratio of the packaging levels included within this packaging code, e.g. 1:5:10 refers to one large Case, with 5 smaller Inner Packs/Bundles inside, each of which contains 2 Eaches for a total of 10 Eaches(required for CN-Rescodes).
    • BatchSizeMaximum – The maximum size of the batch (value optional).
    • AcceptableYield – The acceptable size of the batch determined by percent (required if BatchSizeMaximum is present). Numeric value between 1-100 only.
    • MinimumYield – The absolute minimum size the batch can be determined by percent (required if BatchSizeMaximum is present). Numeric value between 1-100 only.
    • PackagingSerializationType – The type of pattern used to generate serial numbers (value optional).
      • None – The packaging code does not generate serial numbers.
      • Random – The pattern generates serial numbers at random.
      • Sequential –The pattern generates serial numbers in sequential order.
    • PackagingRequiresAggregation – Whether each UOM requires serial numbers (value optional).
      • Aggregated – Each UOM requires serial numbers.
      • Not Aggregated – Not every UOM requires serial numbers.
    • PackagingFilterValue – Control information that allows an RFID reader to select only the packaging code for this packaging level, out of many other levels of packaging codes (value optional). Only numeric values from 0-7 allowed.
    • PackagingGS1CompanyPrefix – Prefix included in the packaging code, assigned by the GS1 organization, must be a numeric value 4 to 6 characters long.
    • PackagingCodeVersion – The Rescode version number, e.g. 81, 88 (required if the PackagingCodeType is CN-Rescode)(value optional).
    • PackagingCodeLevel – The packaging level associated with this ResCode (required if the PackagingCodeType is CN-Rescode)(value optional). Only numeric values 1-9 allowed, with 1 the innermost packaging level.
    • PackagingDataStatus – Whether the packaging information data is active or inactive within TraceLink.
      • Active – The data can be used in messages and UI functions, and TraceLink pulls the data when necessary.
      • Inactive – The data cannot be pulled for other functions within TraceLink.
    • ItemInfoMinTemp – The coldest temperature the product can be exposed without compromising its quality and safety (value optional). If both the ItemInfoMinTemp and ItemInfoMaxTemp are present, the ItemInfoMinTemp must be less than or equal to the ItemInfoMaxTemp.
    • ItemInfoMaxTemp – The hottest temperature the product can be exposed without compromising its quality and safety (value optional). If both the ItemInfoMinTemp and ItemInfoMaxTemp are present, the ItemInfoMaxTemp must be greater than or equal to the ItemInfoMinTemp.

    • ItemInfoTempScale – The temperature scale that the ItemInfoMinTemp and ItemInfoMaxTemp are entered in (required if either ItemInfoMaxTemp or ItemInfoMaxTemp are present):

      • Celsius
      • Fahrenheit
      • Kelvin
    • ItemInfoLightSensitive – Indicates whether exposure to light can compromise the product's quality and safety (value optional):
      • Yes – Exposure to light can compromise the product's quality and safety.
      • No – Exposure to light does not compromise the product's quality and safety.
    • ItemInfoMarketDosageForm – The form the product is dispensed according to a specific Target Market's set of values (value optional).
    • ItemInfoLightSensitive – Indicates whether exposure to light can compromise the product's quality and safety (value optional):
      • Yes – Exposure to light can compromise the product's quality and safety.
      • No – Exposure to light does not compromise the product's quality and safety.
    • ItemInfoShelfLifeUOT – Indicates the unit of time that the ItemInfoShelfLife is entered in (required if ItemInfoShelfLife is present):
      • Days (default)
      • Months
      • Years
    • ItemInfoShelfLife – The length of time that a product remains consumable for (value optional, must be a number between 1-9999).

    • CountryMarketRegistrationClassification – The type of medicine that a product is registered as (value optional):

      • Biological – A medicine that is manufactured in a living system such as a microorganism, or plant or animal cells.
      • Chemical – A medicine that is typically manufactured through chemical synthesis.
      • Patent Medicine – A traditional or herbal medicine with a standardized formula that is packaged into pill or tablet form and sold over the counter.
    • CountryMarketPrescriptionDrugType – The medicine classification for a product (value optional).
    • CountryMarketPermanentImportLicenseNumber – The license number granted to import product that cannot be exported and will remain in the country permanently (value optional).
    • CountryMarketPermanentImportLicenseEndDate – The date on which the CountryMarketPermanentImportLicenseNumber expires (value optional).
    • CountryMarketTemporaryImportLicenseNumber – The license number granted to import product that will remain in the country temporarily before being re-exported (value optional).
    • CountryMarketTemporaryImportLicenseEndDate – The date on which the CountryMarketTemporaryImportLicense expires (value optional).
    • CountryMarketImporterID – The identifier value of the company that is importing the product into the Target Market (value optional).
    • CountryMarketImporterIDType – The identifier type of the company that is importing the product into the Target Market (value optional).
    • CountryMarketDrugRepackagingLicenseNumber – The license number granted to repackage a product (value optional).
    • CountryMarketRepackagingLicenseEndDate – The date on which the CountryMarketDrugRepackagingLicenseNumber expires (value optional).
    • CountryMarketRepackagerID – The identifier value of the company that repackages the product (value optional).
    • CountryMarketRepackagerIDType – The identifier type of the company that repackages the product (value optional).
    • CountryMarketMarketingAuthorizationNumber – The product’s authorization number issued by a government agency (value optional).
  5. Select Submit.

    The View Product Master Data screen displays, and TraceLink begins asynchronously processing the product information. Go to Info Exchange to see the status of the asynchronous import, as well as any errors generated by the CSV file.

Tips

  • For the definitions and formats of identifiers and item codes, see Identifier and Item Code Types.
  • To download an example CSV file, select ProductsSample.csv.

CSV processing rules

  • If multiple item codes are specified, the one specified in the first row must be the ItemCodePrimary.
  • Due to the possibility of multiple item codes, the CSV import adds new item codes found in the import file and does not replace existing item codes (e.g. TraceLink cannot differentiate between changing a value and adding a value).
  • Do not represent a null value in a CSV file with any type of character or empty space; simply enter a comma to move to the next value.
  • Multiple selections (if applicable) can be made within the CSV file, but they must be separated by a pipe (|) symbol and not a comma.
  • Some information can have more than one instance in the CSV file. If the following information is provided multiple times for one product (e.g. more than one item code is provided), the second instance (and beyond) must be entered in the rows directly below the main row:
    • Item Code
    • Target Market

      • Distribution Partner IDs

    • Export Markets
    • Item Information
    • Packaging Information

    Additional rows cannot contain a ProductGroupCode, CountryMarket, ItemStatus, or DataStatus.

The following tables list the required fields in Product Master Data for syncing product information for all US target markets to Product Information Manager to support the US DSCSA saleable returns requirements. Some fields stated here as required do not display the red asterisk in the UI but are required for syncing to Product Information Manager.

Field

Description

Values

Data Status

Whether the product data is active within TraceLink.

 CSV Element Header: DataStatus
  • Active – The data can be used in messages and UI functions, and TraceLink pulls the data when necessary.
  • Inactive – The data cannot be pulled for other functions within TraceLink.

Must be Active to sync the product entry to Product Information Manager.

Item Status

The product's commercial status.

 CSV Element Header: ItemStatus
  • Released – The company approved the product for commercial release.
  • Alternate items available – The company has alternate items that can take the place of this product.
  • Phase out – The company phased out this product from production and sale.
  • Items no longer stocked – The company does not currently stock this product.
  • Withdrawn – The company removed this product from the market.

Must be Released to sync the product entry to Product Information Manager.

Field

Description

Values

Item Code Type

The unique item code that identifies this product. Products require an item code for every target market. Each item code type can only be used once for each product, except for Internal Material Number.

 CSV Element Header: ItemCodeType

For more information, see Identifier and Item Code Types.

Must include:

  • At least one NDC-442, NDC-532, NDC-541, or NDC-542 if the Owner needs to sync the product entry to Product Information Manager.

Item Code Value

The value of the Item Code Type. The value must be unique within the Item Code Type, and special characters (e.g. -, ., /. \) are removed from this value.

 CSV Element Header: ItemCodeValue

For more information, see Identifier and Item Code Types.

Primary Item Code

The radio button indicates the primary item code used by this company. TraceLink uses the primary item code to identify the correct product when the user updates the product master data by importing a CSV file or with an asynchronous message.

 CSV Element Header: ItemCodePrimary

The first Item Code in the CSV must be the Primary Item Code.

n/a

Field Name

Description

Values

Country Market Code

Two-letter ISO 3166-1alpha-2:1997 Country Code of the Target Market's country.

 CSV Element Header: CountryMarket

Must include a target market that is also defined for syncing on the Product Information Manager Data Rules screen in Management to sync the product entry to Product Information Manager.

Product Type

Type of product. Traceability regulations differ depending on the product type (e.g. over-the-counter drugs do not fall under DSCSA regulations in the US). For informational purposes only, not compliance reporting.

 CSV Element Header: CountryMarketProductType
  • Bulk Pharmaceutical – A product that is the main active ingredient in one or more pharmaceutical formulas (e.g. antibiotics).
  • Derivative Product – A product derived from another chemical compound.
  • Medical Device – A device developed and used for a medical purpose.
  • Nutritional Product – A specific class of over-the-counter product use for health and nutrition benefit.
  • OTC Drug – A medicine available over the counter.
  • Prescription Drug – A medicine available by prescription only.

Traceability Required

Indicates whether the product legally needs to be traced through the pharmaceutical supply chain.

 CSV Element Header: CountryMarketTraceabilityRequired
  • Not Required – The product is exempt from tracking.
  • Required – The product requires tracking.

Product Origin

How the company acquires 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.

 CSV Element Header: CountryMarketProductOrigin
  • Direct Purchase from Exclusive Distributor – The company purchased the product from the sole distributor of the product.
  • Direct Purchase from Manufacturer – The company purchased the product from the manufacturer.
  • Direct Purchase from Repackager – The company purchased the product from a repackager.
  • Indirect Purchase – The company purchased the product from a wholesale distributor.
  • Originator (Exclusive Distributor) – The company, as a wholesale distributor, directly purchased the product from the manufacturer and serves as the sole distributor of the product. This option only applies if the Country Market Code is United States.
  • Originator (Manufacturer) – The company manufactures the product.

MAH ID

The company or location identifier of the MAH, which must exist in Company or Partner Master Data. Required if MAH is selected in the Manufactured By field.

 CSV Element Header: CountryMarketMAHId and CountryMarketMAHIDType

For more information, see Identifier and Item Code Types.

Must be a GLN and the identifier must exist in Company Master Data to sync the product entry to Product Information Manager.

An export market is not required.

Field

Description

Values

Language Code

Language for the item information.

Must include:

  • English for US.

    Only one English item information can be defined if the product entry must be synced to Product Information Manager.

 CSV Element Header: ItemInfoLanguageCode

n/a

Product Description

Typically includes the product name, dosage, form, and the number of doses.

 CSV Element Header: ItemInfoProductDescription

n/a

Product Name

The name of the product.

 CSV Element Header: ItemInfoDrugName

n/a

Generic Name

The chemical or non-proprietary name of the product.

 CSV Element Header:

ItemInfoGenericName

n/a

Manufacturer

The name of the manufacturer or re-packager as it appears on the product label.

 CSV Element Header: ItemInfoManufacturer

n/a

Strength

The strength of the product (e.g. 100 mg).

 CSV Element Header: ItemInfoStrength

 n/a

Dosage Form

The form the product is dispensed in (e.g. tablet or pill).

Required if:

  • US [United States] is a Target Market, the Language Code is English, and the Product Type is not Medical Device, OTC Drug, Nutritional Product, or Derivative Product.
  • The Owner needs to sync the product entry to Product Information Manager.

 CSV Element Header: ItemInfoDosageForm

n/a

Package Size / Spec

The number of individual doses in the pack.

 CSV Element Header: ItemInfoPackageSize

n/a

Field

Description

Values

Packaging Code Type

The serial numbers for the product are generated according to the packaging code type. If necessary, define a packaging code for each packaging unit of measure that needs to be tracked.

 CSV Element Header: PackagingCodeType
  • CN-ResCode – This packaging code type is specific to China (must be 5 digits).
  • GTIN-14 – (Global Trade Item Number) This packaging code type is accepted in any country (must be 14 digits).
  • NTIN – (National Trade Item Number) This packaging code type is specific to a single country (must be 14 digits).

Must be:

  • GTIN-14 to sync the product entry to Product Information Manager.

Packaging Code

The unique value for the Packaging Code Type. See Packaging Code Type above for the field requirements.

 CSV Element Header: PackagingCode

n/a

Packaging UOM

(Packaging Unit of Measure) Determines the level of the packaging hierarchy for this packaging code. If multiple packaging codes are defined, serial numbers can be generated for each level of the packaging hierarchy.

 CSV Element Header: PackagingUOM
  • Primary – The level of packaging that physically touches the product, i.e. blister packs (not available for CN-ResCodes).
  • Each – The smallest salable unit of the product.
  • Inner Pack/Bundle – A grouping of eaches.
  • Case/Shipper – A grouping of inner packs/bundles or a grouping of eaches if the packaging hierarchy does not include inner packs/bundles.
  • Pallet – The level of packaging with cases grouped together on a pallet (not available for CN-ResCodes).
  • None – Available only for CN-Rescodes.

Must be:

  • Each if the Owner needs to sync the product entry to Product Information Manager. Only one Packaging Code for each Packaging UOM can be defined. If more than one packaging code is defined for the same packaging UOM, TraceLink does not sync the product entry to Product Information Manager. TraceLink also does not sync Primary packaging codes.

Container Aggregation Quantity

Number of children contained in this level of shipment. E.g. for a Case, the Container Aggregation Quantity would list the number of Inner Packs contained in each Case. TraceLink only uses this field for compliance reporting purposes, not validation during aggregation.

Required if:

  • The Packaging UOM is Each and the Owner needs to sync the product entry to Product Information Manager.

 CSV Element Header: PackagingContainerAggregationQty

Must be 0 for eaches if the Owner needs to sync the product entry to Product Information Manager. TraceLink also syncs other packaging UOMs that have a Container Aggregation Quantity set, as long as an each is defined with a Container Aggregation Quantity of 0.

GS1 Company Prefix

Prefix included in the packaging code, assigned by the GS1 organization, must be a numeric value 4 to 6 characters long.

 CSV Element Header: PackagingGS1CompanyPrefix

Must be a numeric value 4 to 6 characters long to sync the product entry to Product Information Manager.

Data Status

Whether the packaging information data is active or inactive within TraceLink.

 CSV Element Header: PackagingDataStatus
  • Active – The data can be used in messages and UI functions, and TraceLink pulls the data when necessary.
  • Inactive – The data cannot be pulled for other functions within TraceLink.
  1. Hover over the User profile in the top right of any screen, and then select Management.
  2. Select Product Information Manager Data Rules from the Management landing page.

    or

    Expand the Management Navigation in the header of any screen, and select Product Information Manager Data Rules.

  3. In the Master Data Share Rules table:
    1. Select the Target Market for packaging codes whose product master data must be synced to Product Information Manager (each Target Market can only be selected once):
      • American Samoa
      • Guam
      • Northern Mariana Islands
      • Puerto Rico
      • United States of America
      • US Minor Outlying Islands
      • Virgin Islands
    2. Leave the Allow Verification checkbox selected to add the product's packaging code to the Product Directory in Product Information Manager so that the downstream supply chain can verify against the product's serial number information (optional and displays only for Managers whose company also links to the Product Verification module).
    3. Select the Allow Download checkbox to set the product master data record to Shared to Network in Product Information Manager (Master Data Share), which allows the downstream supply chain to download the master data (optional).
  4. Select Rule in the header of the table and repeat the previous steps to add a rule for another Target Market.
  5. Select Save.

    The Product Information Manager Data Rules screen refreshes with the new data rules.

    TraceLink syncs the product master data from Master Data Exchange to Product Information Manager (Master Data Share), as well as Product Information Manager (Product Verification) if the Allow Verification checkbox is selected. Any new or updated products sync within 24 hours of the update, and any previously existing products sync at the next scheduled time. Confirm that the Product Directory record successfully synced by searching for it in Product Information Exchange.

After adding the product to Master Data Exchange and setting the data synchronization rules, Producers can check the Product Directory to make sure the product successfully synced to Product Information Manager.

  1. Hover over Modules, and then select Product Information Exchange.
  2. Select Product Directory.
  3. Select the Search icon on the left.
  4. Fill in one or more of the following fields:
    • Status – The product's status within Product Information Manager:
      • All
      • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
      • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
    • Packaging Code – The packaging code type and identifier value associated with the product.
    • Last Updated Date Range – Only products updated within the date range specified return in the results.
      • Start – The beginning of the date range, inclusive.
      • End – The end of the date range, inclusive.

  5. Select Search.

    • Status – The product's status within Product Information Manager:
      • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
      • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
    • Producer – The Pharmaceutical Manufacturer or Repackager that owns the product.
    • Packaging Code – The packaging code type and identifier value associated with the product.
    • Last Updated – The last date and time that a user updated the product in Product Information Manager.

Tips

  • To view the Product Information Manager details for the product, select the View Details icon in the Actions column of any row. Select the Edit Product icon on the Product Details screen to update these details.

Update the status of synced products

Search for a product that already has an entry in Product Information Manager and update the verification status, which determines whether the downstream supply chain can verify against that product.

  1. Hover over Modules, and then select Product Information Exchange.
  2. Select Product Directory.
  3. Select the Search icon on the left.
  4. Fill in one or more of the following fields:
    • Status – The product's status within Product Information Manager:
      • All
      • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
      • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
    • Packaging Code – The packaging code type and identifier value associated with the product.
    • Last Updated Date Range – Only products updated within the date range specified return in the results.
      • Start – The beginning of the date range, inclusive.
      • End – The end of the date range, inclusive.

  5. Select Search.

    • Status – The product's status within Product Information Manager:
      • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
      • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
    • Producer – The Pharmaceutical Manufacturer or Repackager that owns the product.
    • Packaging Code – The packaging code type and identifier value associated with the product.
    • Last Updated – The last date and time that a user updated the product in Product Information Manager.
  6. If the Status is Not Shared to Network, select the Share to Network icon in the Actions column to allow the downstream supply chain to verify against that product.

    or

    If the Status is Shared to Network, select the Hide from Network icon in the Actions column to prevent the downstream supply chain from verifying against that product.

If the company sells ownership of the product's NDC to another Producer, the company must set their Product Directory record to expire and enter the FDA Labeler Code for the new Producer.

  1. Hover over Modules, and then select Product Information Exchange.
  2. Select Product Directory.
  3. Select the Search icon on the left.
  4. Fill in one or more of the following fields:
    • Status – The product's status within Product Information Manager:
      • All
      • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
      • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
    • Packaging Code – The packaging code type and identifier value associated with the product.
    • Last Updated Date Range – Only products updated within the date range specified return in the results.
      • Start – The beginning of the date range, inclusive.
      • End – The end of the date range, inclusive.

  5. Select Search.

    • Status – The product's status within Product Information Manager:
      • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
      • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
    • Producer – The Pharmaceutical Manufacturer or Repackager that owns the product.
    • Packaging Code – The packaging code type and identifier value associated with the product.
    • Last Updated – The last date and time that a user updated the product in Product Information Manager.
  6. Select the View Details icon in the Actions column.
  7. Select the Edit Product icon.
  8. Enter the 4- to 6-digit FDA-assigned code of the next company to own the NDC for this product in the Next Owner Labeler Code field.
  9. Enter the End date of the Expiration Date Range, which indicates the expiration date for the final lot of this product that the company must respond to verification requests for.
  10. Select Submit.

    The Product Directory screen displays, and Product Information Exchange saves the updated product information.

Add products manually through Product Information Exchange

This process is not the most efficient or effective method. Syncing products from Master Data Exchange ensures that products stay up to date and provides a 1-step process for adding new products after the data rules have been set. Companies should only add product entries to the Product Directory manually if the company has not linked to Product Information Manager (Master Data Share).

  1. Hover over Modules, and then select Product Information Exchange.
  2. Select Product Directory.
  3. Select Product.
  4. Select the product's Packaging Code type and enter the unique value in the field below the drop-down (GTIN-14 is currently the only Packaging Code type available).
  5. Enter the 4- to 6-digit FDA Labeler Code that identifies the company that owns the NDC for this product.
  6. Enter the GLN for the company that currently owns the product.
  7. Enter the 4- to 6-digit FDA-assigned code of the next company to own the NDC for this product in the Next Owner Labeler Code field (optional).
  8. Select the Verification Status of the product's serial numbers in Product Information Manager (Product Verification):
    • Shared to Network – The product's serial numbers are available for the downstream supply chain to verify against.
    • Not Shared to Network – The product's serial numbers are not available for the downstream supply chain to verify against.
  9. Enter the Expiration Date Range of the lots for this product that the company must respond to verification requests for:
    1. Enter the Start date of the range.
    2. Enter the End date of the range (required if Next Owner Labeler Code is entered).
  10. Select Submit.

    Product Information Exchange adds the product record to the Product Information Manager (Product Verification) repository. TraceLink shares this information with external Verification Router Services so that these external systems can send verification requests for this product to TraceLink.

    After submitting the product, add serial number information for this product to the Product Information Manager (Product Verification) repository in one of two ways:

    • Set the data rules in the Management Web UI or with the Product Information Exchange REST messages to share serial number information from the company's Serialized Operations Manager repository.
    • Send the Product Information Manager (Product Verification) Upload Product Identifiers REST Request to TraceLink with a CSV file containing the serial number information.

Tips

  • The new product record displays at the top of the Product Directory results table by default.
  • To edit the fields listed above, except for Packaging Code, select the View Details icon on the Product Directory screen, and then select the Edit Product icon.

  • If End date is entered, it must be less than 50 years from the current date.

  • A Product Directory record cannot be created if the Start date overlaps with the End date of an existing active record.