Product How-Tos

1. Hover over Master Data Exchange in the Modules drop-down at the top of the screen, and then select Product Master Data.
2. Fill in one or more of the following search fields:
   • Item Code Type – The item code type for the product's unique Item Code.

     For more information, see Identifier and Item Code Types.

   • Item Code – The unique item code for the product. Mandatory if the Item Code Type selected is any option except All.

     For more information, see Identifier and Item Code Types.

   • Product Group Code – The internal code identifying all versions of the product (e.g. group code for all variations of MigraineMed).
   • Packaging Code Type – The packaging code type for the product's packaging code.
     • All (default)
     • 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).
   • Packaging Code – The unique packaging code for the product(s). See Packaging Code Type above for details on the requirements.
   • Product Description – Typically includes the product name, dosage, form, and the number of doses.
   • Data Status – 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.
3. Select Search.

   The results display in the table.

• Enter an asterisk (*) in the Product Description field to return all Product Master Data entries.

  The results table can only display up to 10,000 entries. If Master Data has more than 10,000 entries, the search criteria need to be narrowed.

• To view a product's information, select View Details in the Actions column.
  • To edit the product's information, select Edit Product.

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 the Data Status for the product:
      • 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.
   4. Select the product's commercial Item Status:
      • 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.

      When the product has an Export From Country of India, the only Item Status options are Released, Items no longer stocked, and Withdrawn.

4. On the Item Codes tab:
   1. Select an Item Code Type from the drop-down.
   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.

      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 (optional 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.
      • Food Supplement – A medicine available over the counter that is used for health and nutritional benefits.
      • 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 (optional):
      • 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 (optional):
      • 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 (required if Manufactured By is MAH).
   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:
   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 a Language Code for the item information.
   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 (optional).
   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 (optional).
   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 (optional).
   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. 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.

   4. Select the Packaging UOM (unit of measure) to indicate the level of the packaging hierarchy for this packaging code:
      • 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.
   5. Enter the number of the lower Packaging UOM contained in the this level of aggregation in the Container Aggregation Quantity field, e.g. for a Case, the Container Aggregation Quantity would list the number of Inner Packs contained in each Case (optional for informational purposes only, not validation during aggregation).
   6. 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).
   7. 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).

         

   8. 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.
   9. 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.
   10. 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).
   11. Enter the GS1 Company Prefix included in the Packaging Code, assigned by the GS1 organization (required if the Packaging Code Type is GTIN-14), must be a numeric value 6 to 12 characters long. TraceLink uses this prefix to convert serial numbers in barcode format to the EPC URN format used in EPCIS messages.
   12. Enter the product Code Version number, e.g. 81, 88 (required if the Packaging Code Type is CN-ResCode).
   13. 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).
   14. 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.
   15. Select Add New and repeat the previous steps to add another packaging code for a different UOM.
9. Select Submit.

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

Some optional fields might be mandatory based on a country's regulatory requirements.

• Turkey:
  • Target Markets tab:
    • Product Type

Download the Quick Reference Guide for each country with a Compliance app to view their specific required fields:

• All Fields
• Brazil
• China
• European Union
• India
• Russia
• South Korea
• United States

Some optional fields might be mandatory if products with a US Target Market must be synced to Product Information Manager. Download the Quick Reference Guide.

• For the definitions and formats of identifiers and item codes, see Identifier and Item Code Types.

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).
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.

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

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 Export & Download.
3. Select Create Data File.
4. Fill in one or more of the following search fields:
   • Item Code Type – The type of unique identifier for the product.
   • Item Code – The unique value of the product's identifier.

     For more information, see Identifier and Item Code Types.

   • Product Group Code – 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). The View Product Master Data screen uses this code to search for all products in the same classification entered into Product Master Data.
   • Packaging Code Type – The type of packaging code designating the product's packaging level.
   • Packaging Code – The unique value that designates the product's packaging level.
   • Product Description – Typically includes the product name, dosage, form, and the number of doses.
   • Data Status – Indicates whether the Master Data tied to this location is active or inactive.
     • All
     • 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.
5. Select Submit.

   The Export and Download screen displays, and TraceLink begins asynchronously generating the export.

• Leave all the search fields set to their defaults to download every product in Product Master Data and all of their associated fields.
• To download the CSV file after it finishes generating, select the link in the File Name column on the Export and Download screen.
• The Export Filtered Product Data to CSV link on the View Product Master Data screen only includes the table columns in the CSV file, not all of the fields associated with the product entries.