Target Markets

Overview

Select the Target Markets tab on the Edit Product screen.

Add or edit the markets that the product will be sold in, including any market specific information about the product and its manufacture.Depending on the market, various product and manufacturing information is required to comply with that countries regulations. See Country Requirements for Product Master Data for a list countries and their required fields.

Values entered in the item information fields are sometimes automatically populated in other TraceLink applications when the product's item code is used.

The data fields are restricted to a maximum of 255 characters, including alphanumeric and special characters.

Target Markets

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

  • Product Type – 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.
    • 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.
  • Point of Dispense Verification – Whether or not the product requires verification at or just prior to the dispensation to a patient.
    • 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.

  • Traceability Required – If the Country Market Code is set to GB (United Kingdom), this field indicates whether the product should be reported to the EU Hub:

    • Not Required – This product is destined for a location in the United Kingdom that is not Norther Ireland and does not need to be reported to the EU Hub.
    • Required – This product is destined Norther Ireland and must to be reported to the EU Hub.
  • PCID – Medicinal Product Package Identifier (PCID) determines the EU Hub's Article 57 Code on Master Data Compliance Reports.

    • For more information, see the EU Compliance Online Help.

  • 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.

    For more information, see Identifier and Item Code Types.

  • Distribution Partner IDs – 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. Only mandatory if the user's company has distribution partners.

    For more information, see Identifier and Item Code Types. Limit of 100 identifiers per Target Market.

  • Scheduled Drug – Indicates whether the product is classified in one of the schedules assigned to controlled substances.
    • Yes – The target market considers the product a scheduled drug.
    • No – The target market does not consider the product a scheduled drug.
  • Manufactured By – The type of organization manufacturing the product.
    • 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.
  • Manufacturing CMO ID – If the Manufactured By drop-down is set to CMO and the Target Market is in India, this value must be the GS1 Company Prefix.

    For more information, see Identifier and Item Code Types.

  • Marketing Authorization Number – The product’s authorization number issued by a government agency.
  • Product Type – 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.
    • 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.
  • Product Origin – 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 Country Market Code is United States.
    • Originator (Manufacturer) – The company manufactures the product.
  • Country Market Code – Two-letter ISO 3166-1alpha-2:1997 Country Code of the Target Market's country.
  • Market Information
    • Product Type – Type of product.

      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.
    • Registration Classification – The type of medicine that a product is registered as:
      • 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.
    • Prescription Drug Type – The medicine classification for a product (e.g. narcotic).
    • Marketing Authorization Number – The product’s authorization number issued by a government agency.
    • Point of Dispense Verification – Whether or not the product requires verification at or just prior to the dispensation to a patient.
      • 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.
    • Traceability Required – Indicates whether the product legally needs to be traced through the pharmaceutical supply chain.
      • Not Required – The product is exempt from tracking.
      • Required – The product requires tracking.
    • Product Origin – 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 Country Market Code is United States.
      • Originator (Manufacturer) – The company manufactures the product.
    • Scheduled Drug – Indicates whether the product is classified in one of the schedules assigned to controlled substances.
      • Yes – The target market considers the product a scheduled drug.
      • No – The target market does not consider the product a scheduled drug.
    • PCID – Medicinal Product Package Identifier (PCID) determines the EU Hub's Article 57 Code on Master Data Compliance Reports.

      For more information, see the EU Compliance Online Help.

    • Product Category Identifier – The commodity tariff code that classifies the product when determining its customs value.

    • Reporting Item Code – The product's Item Code that is used in a specific Target Market instead of the Target Markets default Item Code for compliance reporting. The Reporting Item Code type and value cannot already be entered on the Item Codes tab.

      For more information, see Identifier and Item Code Types.

    • Product Image – 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.

      Maximum file size is 10KB. The file format must be .bmp, .gif, .jpg, or .png. CSV file can include a URL to the image.

  • Manufacturing Information

    • Production Type – Where the product is manufactured relative to the country defined in the Target Market.

      • 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.
    • Manufactured By – The type of organization manufacturing the product.
      • 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.
    • 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. If the Target Market is in India, this value must be the GS1 Company Prefix.

      For more information, see Identifier and Item Code Types.

    • MAH Internal Material Code – The Internal Material Code used by the MAH for the product. This is used in Transfer Shipment workflow from CMO to MAH.

      TraceLink recommends updating the CMO's Product Master Data with the MAH's Internal Material Code if the CMO performs any commissioning or disposition assignment activities using the CMO's Internal Material Code. This update is necessary to ensure that the information can be appropriately utilized by the MAH when updating through the Transfer Shipment workflow.

    • Manufacturing CMO ID – The company ID for the CMO manufacturing the product.

      For more information, see Identifier and Item Code Types.

    • CMO Internal Material Code – The Internal Material Code used by the CMO that manufactured the product.
    • Virtual CMO ID – The identifier for a third-party contracted to oversee the CMO.

      For more information, see Identifier and Item Code Types.

    • VCMO Internal Material Code – The Internal Material Code used by the Virtual CMO for the product.
    • License for Permanent Import – The license number granted to import product that cannot be exported and will remain in the country permanently.
    • License for Permanent Import End Date – The date on which the License for Permanent Import expires.
    • License for Temporary Import – The license number granted to import product that will remain in the country temporarily before being re-exported.
    • License for Temporary Import End Date – The date on which the License for Temporary Import expires.
    • Importer ID – The identifier type and value of the company that is importing the product into the Target Market.
    • Repackaging License Number – The license number granted to repackage a product.
    • Repackaging License Number End Date – The date on which the Repackaging License Number expires.
    • Repackager ID – The identifier type and value of the company that repackages the product.
    • Distribution Partner IDs – 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.

      For more information, see Identifier and Item Code Types. Limit of 10 identifiers in the user interface and 100 identifiers in the CSV import per target market.

Available Actions

  1. In the Country Market Code column:

    • Enter a Country Market Code in the type-ahead field, or select the menu button to the right of the field to see all Country Market Codes.

      Use the forward and backward arrows at the bottom of the menu to navigate through the options.

  2. In the Market Information column:
    1. Select the Product Type from the drop-down.
    2. Select the Registration Classification from the drop-down.
    3. Select the Prescription Drug Type from the drop-down.
    4. Select the Point of Dispensation Verification from the drop-down.
    5. Select whether traceability is required from the Traceability Required drop-down.
    6. Select the Product Origin from the drop-down.
    7. Select whether the product is a Scheduled Drug from the drop-down.
    8. Select the PCID from the drop-down.
    9. Enter the Product Category Identifier in the text field.
    10. Select the Reporting Item Code from the drop-down, and enter the value in the text field to the right.
    11. Select Choose File to upload a Product Image.
  3. In the Manufacturing Information column:
    1. Select the Production Type from the drop-down.
    2. Select the Manufactured By from the drop-down.
    3. Select the MAH ID from the drop-down, and enter the value in the text field to the right.
    4. Enter the MAH Internal Material Code in the text field.
    5. Select the Manufacturing CMO ID from the drop-down, and enter the value in the text field to the right.
    6. Enter the CMO Internal Material Code in the text field.
    7. Select the Virtual CMO ID from the drop-down, and enter the value in the text field to the right.
    8. Enter the VCMO Internal Material Code in the text field.
    9. Enter the License for Permanent Import in the text field.
    10. Select the License for Permanent Import End Date from the date picker.
    11. Enter the License for Temporary Import in the text field.
    12. Select the License for Temporary Import End Date from the date picker.
    13. Select the Importer ID from the drop-down, and enter the value in the text field to the right.
    14. Enter the Repackager License Number in the text field.
    15. Select the Repackager License Number End Date from the date picker.
    16. Select the Repackager ID from the drop-down, and enter the value in the text field to the right.
    17. Add Distribution Partner ID(s):
      • To add the first 10 Distribution Partner IDs:
        • Select the Distribution Partner ID from the drop-down, and enter the value in the text field to the right.
      • To add more than 10 Distribution Partner IDs:

        1. Enter all product information, and then select Submit.

        2. Export the details for the specific product on the Create Data File screen.
        3. Download the previously generated CSV file on the Export and Download screen.

          See Export Results to CSV for how to open a CSV file in Excel.

        4. Add the identifier values in the DistributionPartnerID column and the identifier type in the DistributionPartnerType column of the CSV file.
        5. Import the data file on the Import Product Master Data screen.

    If more than 10 Distribution Partner ID(s) already exist for a Target Market, select Distribution Partner IDs to download the product data in CSV form and continue at step iv above to add more.

  4. To delete or add Target Markets:

    • Select Add New.

      • or

    • Select the Remove icon.
  5. Select Submit.

    The View Product Details screen displays, and the updated product's information is saved.