Set up products

Companies that own or link to OPUS apps have access to the Master Data menu item, which displays in the side menu of the OPUS Platform. The Partners functionality available to users depends on the role they are assigned.

For more information, see Master Data Roles.

Add the product information including the item codes, target market, item information, packaging information and export market information.

1. Select the Main Menu icon.
2. Select Master Data in the main menu.
3. Select Product from the left menu.
4. Select Products from the left menu.
5. Select the New button.
6. Fill in the following fields in the Product Information section:
   1. Status drop-down – Required. The product information is either active or inactive within TraceLink:
      • Active – The data can be used in messages and UI functions, and TraceLink leverages the data when necessary.
      • Inactive – The data cannot be used for other functions within TraceLink.
   2. Item Status drop-down – Required. The product's commercial status:
      • Released – The product is approved for commercial sale.
      • Alternate items available – An alternate product is available.
      • Phase out – The product is no longer available for production or sale.
      • Items no longer stocked – The product is not currently stocked.
      • Withdrawn – The product is removed from the market.
7. Select the Add icon in the Item Codes section and fill in the following fields:
   1. Item Code Type drop-down – The item code used for this product. Each item code type can only be used once for each product, except for internal material number.
   2. Item Code Value field – The value associated with the item code. The value must be unique within the Item Code Type, and special characters (e.g. -, ., /. \) are removed from this value.

   3. Primary Item Code switch – Required. The primary item code used for this product. Each company must have at least one identifier type and value combination. One identifier must be designated as the primary identifier, and only one primary identifier is allowed per company. TraceLink uses the primary identifier to match future updates or imports to the correct entity in the TraceLink Network.

      • Yes – The primary item code for this product.
      • No – The item code is not the primary item code for this product.
   4. Select Apply.

      The new item code is added to the Item Codes table.
      

   5. Select the Add icon in the Item Codes section to add another Item Code Type drop-down and Item Code Value field.

8. Select the Add icon in the Item Information section and fill in the following fields:
   1. Language Code drop-down - Specifies the language in which the item information is provided
   2. Product Description field - Required. A clear and concise description of the product.
   3. Product Name field - Required. The official name of the product.
   4. Manufacturer field - Required. The name of the organization responsible for manufacturing the product.

9. Select Apply.

   The new item information is added to the Item Information table.

10. Select the Add icon in the Item Information section to add another Item Information for the product.

11. Select the Save button.

    The product information, item codes, and item information are saved to the Product.

12. To add details for the newly added product details, select the Name hyperlink in the results table.

13. Select the Edit button.

14. Ensure that your Product Group Code, Effective Date, Data Status, and Item Status are visible in the Product Information section.

15. Select the Add icon in the Item Codes section and fill in the following fields:
    1. Item Code Type drop-down – The item code used for this product. Each item code type can only be used once for each product, except for internal material number.
    2. Item Code Value field – The value associated with the item code. The value must be unique within the Item Code Type, and special characters (e.g. -, ., /. \) are removed from this value.

    3. Primary Item Code switch – Required. The primary item code used for this product. Each company must have at least one identifier type and value combination. One identifier must be designated as the primary identifier, and only one primary identifier is allowed per company. TraceLink uses the primary identifier to match future updates or imports to the correct entity in the TraceLink Network.

       • Yes – The primary item code for this product.
       • No – The item code is not the primary item code for this product.
    4. Select Apply.

       The new item code is added to the Item Codes table.
       

    5. Select the Add icon in the Item Codes section to add another Item Code Type drop-down and Item Code Value field.

16. Select the Add icon in the Target Market Details section and fill in the following fields:
    1. Distribution Partner IDs:
       
       • Type drop-down – Required. 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 field – Required. The value associated with the Distribution Partner ID. The value must be unique within the Distribution Partner ID Type, and special characters (e.g. -, ., /. \) are removed from this value.

       Select the Add icon to add another Distribution Partner ID Type drop-down and Distribution Partner ID Value field.

    2. Country Market Code drop down - Required. The market code associated with the country.
    3. Product Type drop-down – The type of product.
       • Prescription Drug – A prescription medicine.
       • Medical Device – A medical device.
       • OTC Drug – An over the counter product.
       • Nutritional Product – A nutritional product.
       • Derivative Product – A derivative product.
       • Bulk Pharmaceutical – A bulk pharmaceutical product.
       • Food Supplement – A nutritional product.
       • Medical Product - A medical product.
    4. Prescription Drug Type drop-down – Specifies whether the medicine is available by prescription only:
       See the information that displays on the Prescription Drug Type

       • Anabolic steroid – An anabolic steroid prescription product.
       • Antiretroviral – An antiretroviral prescription product.
       • Controlled plant – A controlled plant prescription product.
       • Immunosuppressive – An immunosuppressive prescription product.
       • Narcotic – A narcotic prescription product. It is applicable if the target market for this product is India.
       • Other – A prescription product that does not fall into another category. It is applicable if the target market for this product is India.
       • Pharmaceutical precursor chemical – A pharmaceutical precursor chemical prescription product.
       • Prohibited Substance – A prohibited substance prescription product.
       • Psychoactive anorectic – A psychoactive anorectic prescription product. It is applicable if the target market for this product is India.
       • Psychoactive anti-anxiety – A psychoactive anti-anxiety prescription product. It is applicable if the target market for this product is India.
       • Psychoactive anti-epileptic – A psychoactive anti-epileptic prescription product. It is applicable if the target market for this product is India.
       • Psychoactive anti-psychotic – A psychoactive anti-psychotic prescription product. It is applicable if the target market for this product is India.
       • Psychoactive mood stabilizer – A psychoactive mood stabilizer prescription product. It is applicable if the target market for this product is India.
       • Psychoactive sleep inducer – A psychoactive sleep inducer prescription product. It is applicable if the target market for this product is India.
       • Psychoactive stimulant – A psychoactive stimulant prescription product. It is applicable if the target market for this product is India.
       • Psychoactive antidepressant – A psychoactive antidepressant prescription product. It is applicable if the target market for this product is India.
       • Radioactive – A radioactive prescription product.
       • Retinoid – A retinoid prescription product.
       • Toxic drug for medical use – A toxic medical prescription product.
    5. Traceability Required switch – Specifies whether the product legally needs to be traced through the pharmaceutical supply chain:
       • Required – The product requires tracking.
       • Not Required – The product is exempt from tracking.
       • Not Set - The traceability requirement has not been specified.
    6. Scheduled Drug drop-down – Specifies 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.
       • Not Set - The scheduled drug status has not been specified.
    7. Product Image field – The image of the product. Select the hyperlink or the download icon to download the product image. Drag and drop a file to upload or select the browse link to upload the image. Select the remove icon to remove the image.
    8. Reporting Item Code section – The reporting item code for this target market.
       • Type drop-down – The product's Item code that is used in a specific target market instead of the target market's default Item Code for compliance reporting.
       • Value field – The reporting item code value for this target market.
       • Marketing Authorization Number field – The product’s authorization number issued by a government agency.
       • Product Category Identifier field – The commodity tariff code that classifies the product when determining its customs value.
       • Registration Classification drop-down – The product classification at the time of registration:
         • Patent Medicine – The product is classified as a patented medicine.
         • Chemical – The product is classified as chemical.
         • Biological – The product is classified as biological.
       • Point of Dispense Verification switch – Specifies whether the product has a point of dispense verification requirement:
         • Required – The product has a point of dispense verification requirement.
         • No – The product does not have a point of dispense verification requirement.
         • Not Set - The point of dispense verification requirement has not been specified.
       • Product Origin drop-down – Specifies how the product was sourced by the company selling the product:
         • Originator (Manufactuer) – The company is the manufacturer of the product and sells the product into the supply chain.
         • Direct Purchase from Manufacturer – The company acquires the product as a direct purchase from the manufacturer
         • Direct Purchase from Repackager – The company acquires a product as a direct purchase from a repackager who purchased directly from the manufacturer.
         • Direct Purchase from Exclusive Distributor – The company acquires the product as a direct purchase from the exclusive distributor of the manufacturer.
         • Originator Exclusive Distributor – The company that purchased the product is the exclusive distributor of the product.
         • Indirect Purchase – The company acquires a product as an indirect purchase from a supplier or repackager that did not acquire the product directly from the manufacturer.
       • PCID field – The medicinal product package identifier (i.e. PCID) that determines the EU Hub's Article 57 Code on master data compliance reports.
       • Production Type drop-down – Specifies where the product is manufactured relative to the country defined in the Target Market:
         • Locally Manufactured – The company manufactures the product 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.
       • Manufactured By drop-down - The type of organization manufacturing the product:
         • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
         • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
    9. MAH ID:
       • Type drop-down – Conditionally required if MAH is selected in the Manufactured By field. The company or location identifier of the MAH, which must exist in Company or Partner Master Data. If the Target Market is in India, this value must be the GS1 Company Prefix.
       • Value field – Required. The value associated with the MAH ID. The value must be unique within the MAH ID Type and special characters (e.g. -, ., /. \) are removed from this value.
       • MAH Internal Material Code field – The Internal Material Code used by the MAH for the product.
    10. Manufacturing CMO ID:
        • Type drop-down – The company ID for the CMO manufacturing the product.
        • Value field – Required. The value associated with the Manufacturing CMO ID Type. The value must be unique within the Manufacturer CMO ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
        • CMO Internal Material Code field – The Internal Material Code used by the CMO that manufactured the product.
    11. Virtual CMO Identifier :
        • Type drop-down – Required. The Internal Material Code used by the Virtual CMO for the product.
        • Value field – The value associated with the Virtual CMO ID. The value must be unique within the Virtual CMO ID Type, and special characters (e.g. -, ., /. \) are removed from this value.

        • VCMO Internal Material Code field - The Virtual Internal Material Code used by the CMO that manufactured the product.

    12. License for Permanent Import:
        • License Number field – The license number granted to import product that cannot be exported and will remain in the country permanently.
        • Expiration Date field – The date on which the License for Permanent Import expires.
    13. License for Temporary Import:
        • License Number field – The license number granted to import product that cannot be exported and will remain in the country temporarily.
        • Expiration Date field – The date on which the License for Temporary Import expires.
    14. Importer Identifier:
        • Type drop-down – The identifier type and value of the company that is importing the product into the Target Market.
        • Value field – The value associated with the Importer ID. The value must be unique within the Importer ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
    15. Repackaging License:
        • License Number field – The repackager license number.
        • Expiration Date field – The date when the repackaging license number expires (YYYY-MM-DD format).
    16. Repackager ID:
        • Type drop-down – Required. The identifier type and value of the company that repackages the product.
        • Value field – Required. The value associated with the Repackager ID. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.

    To generate T2 documents for US DSCSA compliance, set Country Market Code to US and Traceability Required to Required in the Target Market Details section.

17. Select the Add icon in the Export Market Details section and fill in the following fields:
    1. Export Market:
       • Export from Country drop-down – The country where the exported products are being shipped from. The country is identified using the standard two- or three-letter abbreviation specified in ISO 3166-1alpha-2:1997 country code.
       • Export to Country drop-down – The country where the exported products are being received. The country is identified using the standard two- or three-letter abbreviation specified in ISO 3166-1alpha-2:1997 country code.
       • Unit Price field – The price per unit of the product in the target market. If a unit price is entered and the country manufacturer is IN (India), the value must be a number from 0.50 – 9999999.99.
       • Currency Code drop-down – Conditionally required if the Unit Price is specified. The currency code for the product's unit price in ISO 4217:2015 format.
       • Manufactured By drop-down – The type of organization manufacturing the product:
         • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
         • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
    2. Manufacturer ID:
       • Type drop-down – Required. The type of identifier used for this manufacturer.
       • Value field – The value associated with the Manufactuer ID. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
       • Target Market Exemption switch - if the product is exempted from regulatory compliance in the Export to Country field.
         • Yes – The product is exempted from regulatory compliance.
         • No – The product is not exempted from regulatory compliance.
       • Export Country Exemption Code drop-down – The exemption category code for exempted product with enumeration values in India:
         • 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 the requirements in India.
       • Exemption Reference field – The name of the law or regulation in the destination country for which the exporter has obtained exemption permission.
       • Exemption Date field – The date the exemption request has been granted to the exporter by the governing agency of the destination country (can be the date of the published law).
18. Select the Add icon in the Export Market Details section and fill in the following fields:
19. Select the Add icon in the Item Information Details section and fill in the following fields:
    1. Item Information:
       • Language Code drop-down - Required. The language code.
       • Product Description field – Required. The product description, which includes the product name, dosage, form, and the number of doses.
       • Product Code field – The regulatory product code associated with the product in China, or an additional product code in other target markets.
       • Product Name field – Required. The name of the medicine that is displayed on the product label.
       • Generic Name field – The chemical or non-proprietary name of the product. The generic name describes the chemical make up (atomic or molecular structure) of the product in contrast to the brand name that is used to market it.
       • Manufacturer field – Required. The name of the manufacturer as it appears on the product label.

    2. Manufacturer ID

       • Type drop-down – The ID for the manufacturer or re-packager of the product as it appears on the product label (e.g. GLN 123412341).
       • Value field - The ID Value for the manufacturer or re-packager of the product.
       • Strength field – The strength of the product (e.g. 100 mg).
       • Drug Composition field – The chemical composition of the product. The maximum character length is 500 characters if the Target Market is in India.
       • Dosage Form field – The dosage form of the product (e.g. tablet, capsule).
       • EMVS Dosage Form drop-down – The form the product is dispensed in according to the EU's standard set of values.
       • Market Dosage Form drop-down – The form the product is dispensed according to a specific Target Market's set of values.
       • Container Size field – The size of the container.
       • EMVS Pack Code drop-down – The way the product is packaged to be sold according to the EU's standard set of values.
       • Remarks field – Product-related instructions or comments not described in the previous fields.
       • Min Temperature field – The coldest temperature the product can be exposed without compromising its quality and safety. If the Maximum Temperature and Minimum Temperature values are both provided, the Minimum Temperature must be less than or equal to the Maximum Temperature value.
       • Max Temperature field – The hottest temperature the product can be exposed to without compromising its quality and safety. If the Maximum Temperature and the Minimum Temperature values are both provided, the Maximum Temperature value must be greater than or equal to the Minimum Temperature value.
       • Temperature Scale drop-down – Conditionally required if either Minimum Temperature or Maximum Temperature are present. The temperature scale that the Minimum Temperature and Maximum Temperature are entered in:
         • Celsius
         • Farenheit
         • Kelvin
       • Sensitive to Light switch – whether exposure to light can compromise the product's quality and safety:
         • 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.
       • Shelf Life – Specifies the length of time that a product remains consumable. The value must be a number between 1-9999:
         • Shelf Life Value field - The value of the shelf-life.
         • Shelf Life Unit drop-down:
           • Days – The shelf-life value is provided in days.
           • Months – The shelf-life value is provided in months.
           • Years – The shelf-life value is provided in years.
20. Select the Add icon in the Packaging Information Details section and fill in the following fields:
    1. Packaging Code:
       • Packaging Code Type drop-down – Required. The serial numbers for the product are generated according to the packaging code type. If necessary, define a packaging code for each Packaging Level that needs to be tracked:
         • 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).Product Name field – Required. The name of the medicine that is displayed on the product label.
       • Packaging Code Value field – The value associated with the Packaging Code Type. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
       • Packaging UOM drop-down - Required. The unit of measure used for the packaging level (e.g., Each, Bundle, Case).
       • Container Aggregation Quantity field – The number of children contained in this level of shipment. (e.g. For a Case, the Container Aggregation Quantity lists the number of Inner Packs contained in each Case.):
         • Primary – The level of packaging that physically touches the product (i.e. blister packs). This level is not available for CN-ResCode.
         • Each – The smallest salable unit of the product.
         • Inner Pack and Bundle – A grouping of eaches.
         • Case and 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. This level is not available for CN-ResCode
         • None – Available only for CN-ResCode.
       • Packaging Ratio field – Conditionally required if the Packaging Code Type is CN-ResCode. 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).

         TraceLink only uses this field for compliance reporting purposes, not validation during aggregation.

       • Batch Size Maximum field – The maximum batch size that is acceptable for the product. This field is only used when the value of Packaging Level is EACH.
       • Batch Size Acceptable field - The acceptable batch size acceptable for the product.
       • Batch Size Minimum field - The minimum batch size acceptable for the product.
       • Serialization Type drop-down – The type of serialization required for the packaging code:
         • None – No serialization.
         • Random – Random serialization.
         • Sequential – Sequential serialization.
       • Requires Aggregation drop-down – Specifies if each Packaging Level requires serial numbers:
         • Aggregated – Each Packaging Level requires serial numbers.
         • Not Aggregated – Not every Packaging Level requires serial numbers.
       • Filter Value field – drop-down. 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. The numeric values must be between 0-7.
       • GS1 Company Prefix field – Conditionally required if the Packaging Code Type is GTIN-14. The prefix is included in the packaging code and it is assigned by the GS1 organization.

         TraceLink uses this prefix to convert serial numbers in barcode format to the EPC URN format used in EPCIS messages.

       • Code Version field – Conditionally required if the Packaging Code Type is CN-ResCode. The product code version number (e.g. 81, 88).
       • Code Level field – Conditionally required if the Packaging Code Type is CN-ResCode. The packaging level associated with this ResCode. The numeric values must be between 1-9 with the innermost packaging level.
       • Is Active switch - Indicates whether this specific packaging configuration is currently in use.

         • Yes – The packaging information is enabled and used in TraceLink processes.

         • No– The packaging information is disabled and excluded from TraceLink workflows.

21. Select the Save button.

    The product information, item codes, target markets, export markets, item information, and packaging information are saved to the Product details.

Tips

• In the Item Codes, Target Markets, Export Markets, Item Information, and Packaging Information sections, do one of the following:

  • Select the Add icon to add the a new item code, target market, export market, item information, and packaging information.

  • Select the Remove icon to delete an item code, target market, export market, item information, and packaging information.

  • Select the Edit icon to edit an item code, target market, export market, item information, and packaging information.

  Use the same icons available at the top of the screen to perform these actions.

Import Products master data using a CSV file.

1. Select the Main Menu icon.
2. Select Product from the left menu.
3. Select Products from the left menu.
4. Select the Import button on the top right corner of the screen to import the Product(s) master data.
5. Select a CSV format from the Input Format drop-down.
   1. OPUS CSV Format – is the enhanced, modern format introduced with the OPUS platform.
   2. TTS CSV Format – is the legacy format, originally used in the LSC/TTS platform.
6. In the Input File field, drag and drop the CSV file or select the browse link to search for the file. The element headers listed below are all required in the CSV file, in order, and separated by commas. The data in the individual cells can be empty if a value is not required.
   See the information that displays in the element headers of the CSV file.

   • Primary Item Code Value – The value associated with the selected Primary Item Code Type. Used to uniquely identify each product record across all rows.

   • Primary Item Code Type – The type of identifier paired with the value to form the unique product record key.

   • Item Code Value – The value associated with the Item Code Type. Used with Item Code Type and Is Primary in the item code array. At least one complete row must be provided per product.

   • Item Code Type – The type of item identifier associated with the item code value.

   • Item Code Is Primary – Indicates whether the item code is the primary one. Values must be Yes or No. Only one item code per product should be marked as primary.

   • Item Code Action – Specifies whether the item code entry for that record should be deleted; when set (for example, to Delete), it removes that specific item code row from the record.

   • Product Group Code – Code used to group related products for classification or reporting purposes.

   • Data Status – Indicates the lifecycle status of the product. Allowed values: Active or Inactive. Required in the first row of each product record.

   • Item Status – Indicates the commercial availability status of the product. Required in the first row of each product record.

   • Effective Date – Date on which the product record becomes effective in the system.

   • Target Market Country – Country where the product is marketed or regulated.

   • Target Market Product Type – Classification of the product type for the specified target market.

   • Target Market Point of Dispense Verification – Indicates whether point-of-dispense verification is required in the target market.

   • Target Market Traceability Required – Indicates whether traceability is required for the product in the target market.

   • Target Market Product Origin – Country or region where the product originates for the target market.

   • Target Market Scheduled Drug – Indicates whether the product is classified as a scheduled drug in the target market.

   • Target Market PCID – Product category or classification identifier used in the target market.

   • Target Market Product Category Identifier – Identifier used to classify the product category in the target market.

   • Target Market Reporting Item Code Value – Item code value used for regulatory or compliance reporting in the target market.

   • Target Market Reporting Item Code Type – Item code type paired with the reporting item code value.

   • Target Market Marketing Authorization Number – Marketing authorization or approval number issued by the regulatory authority.

   • Target Market Registration Classification – Regulatory registration classification assigned to the product.

   • Target Market Prescription Drug Type – Prescription drug classification applicable in the target market.

   • Target Market Manufactured By – Name of the organization that manufactures the product for the target market.

   • Target Market Production Type – Type of production process used for the product in the target market.

   • Target Market MAH ID Value – Identifier value for the Marketing Authorization Holder in the target market.

   • Target Market MAH ID Type – Identifier type associated with the MAH ID value.

   • Target Market CMO ID Value – Identifier value for the Contract Manufacturing Organization.

   • Target Market CMO ID Type – Identifier type associated with the CMO ID value.

   • Target Market Virtual CMO ID Value – Identifier value for the virtual CMO.

   • Target Market Virtual CMO ID Type – Identifier type associated with the virtual CMO ID value.

   • Target Market Distribution Partner ID Value – Identifier value for the distribution partner in the target market.

   • Target Market Distribution Partner ID Type – Identifier type associated with the distribution partner ID value.

   • Target Market MAH Internal Material Code – Internal material code used by the MAH for the product.

   • Target Market CMO Internal Material Code – Internal material code used by the CMO for the product.

   • Target Market VCMO Internal Material Code – Internal material code used by the virtual CMO.

   • Target Market License for Permanent Import – License number authorizing permanent import into the target market.

   • Target Market License for Permanent Import End Date – Expiration date of the permanent import license.

   • Target Market License for Temporary Import End Date – Expiration date of the temporary import license.

   • Target Market Importer ID Value – Identifier value for the importer in the target market.

   • Target Market Importer ID Type – Identifier type associated with the importer ID value.

   • Target Market Repackaging License Number – License number authorizing repackaging activities.

   • Target Market Repackaging License Number End Date – Expiration date of the repackaging license.

   • Target Market Repackager ID Value – Identifier value for the repackager.

   • Target Market Repackager ID Type – Identifier type associated with the repackager ID value.

   • Target Market Action – Specifies whether the target market entry for that record should be deleted; when set (for example, to Delete), it removes that specific target market row from the record.

   • Export Market Export from Country – Specifies the country from which the product is authorized or configured to be exported.

   • Export Market Export to Country – Specifies the destination country to which the product is authorized or configured to be exported.

   • Export Market Unit Price – Unit price of the product for export transactions.

   • Export Market Currency Code – Currency code used for export pricing.

   • Export Market Target Market Exemption – Indicates whether a regulatory exemption applies in the export market.

   • Export Market Export Country Exemption Code – Code identifying the applicable export exemption.

   • Export Market Exemption Reference – Reference identifier for the export exemption.

   • Export Market Exemption Date – Date on which the export exemption is effective.

   • Export Market Manufactured By – Name of the manufacturer for exported products.

   • Export Market Manufacturer ID Value – Identifier value for the export market manufacturer.

   • Export Market Manufacturer ID Type – Identifier type associated with the manufacturer ID value.

   • Export Market Action – Specifies whether the export market entry for that record should be deleted; when set (for example, to Delete), it removes that specific export market row from the record.

   • Item Information Product Code – Product code associated with the item information record.

   • Item Information Language Code – Language used for item information content.

   • Item Information Product Description – Description of the product.

   • Item Information Drug Composition – Active ingredients or composition of the drug product.

   • Item Information Remarks – Additional notes or remarks about the product.

   • Item Information Product Name – Name of the product.

   • Item Information Generic Name – Generic or non-proprietary name of the product.

   • Item Information Manufacturer – Name of the product manufacturer.

   • Item Information Manufacturer ID Value – Identifier value for the manufacturer.

   • Item Information Manufacturer ID Type – Identifier type associated with the manufacturer ID value.

   • Item Information Strength – Strength or concentration of the product.

   • Item Information Dosage Form – Dosage form of the product.

   • Item Information EMVS Dosage Form – EMVS-compliant dosage form value.

   • Item Information Container Size – Size of the product container.

   • Item Information EMVS Pack Code – EMVS-compliant packaging code.

   • Item Information Minimum Temperature – Minimum storage temperature for the product.

   • Item Information Maximum Temperature – Maximum storage temperature for the product.

   • Item Information Temperature Scale – Temperature scale used for storage limits.

   • Item Information Sensitive to Light – Indicates whether the product is sensitive to light.

   • Item Information Market Dosage Form – Market-specific dosage form description.

   • Item Information Shelf Life – Shelf life duration of the product.

   • Item Information Shelf Life Unit – Unit of measure for the shelf life value.

   • Item Information Action – Specifies whether the item information entry for that record should be deleted; when set (for example, to Delete), it removes that specific item information row from the record.

   • Packaging Information Packaging Code Value – Value of the packaging code used to identify the packaging level.

   • Packaging Information Packaging Code Type – Type of packaging code associated with the packaging code value.

   • Packaging Information Packaging Level – Packaging hierarchy level represented by the packaging code.

   • Packaging Information Container Aggregation Quantity – Quantity of items aggregated within the container.

   • Packaging Information Packaging Ratio – Ratio defining the relationship between packaging levels.

   • Packaging Information Batch Size Maximum – Maximum allowable batch size for the packaging configuration.

   • Packaging Information Batch Size Acceptable – Acceptable batch size for the packaging configuration.

   • Packaging Information Batch Size Minimum – Minimum allowable batch size for the packaging configuration.

   • Packaging Information Serialization Type – Serialization method applied to the packaging level.

   • Packaging Information Requires Aggregation – Indicates whether aggregation is required for the packaging level.

   • Packaging Information Filter Value – Filter value used to control packaging configuration applicability.

   • Packaging Information GS1 Company Prefix – GS1 company prefix used to generate packaging identifiers.

   • Packaging Information Code Version – Version of the packaging code standard used.

   • Packaging Information Code Level – Code level associated with the packaging hierarchy.

   • Packaging Information Data Status – Lifecycle status of the packaging information record.

   • Packaging Information Action – Specifies whether the packaging information entry for that record should be deleted; when set (for example, to Delete), it removes that specific packaging information row from the record.

   • Item Information Language Code – Specifies the language of the item information. Required if any item information field is populated.

   The root row is the first row of each record containing all parent-level fields, and all subsequent rows for that record are considered child rows containing array data.

7. Select Apply.

   The updated Product master data is imported to link Products to the company's apps and networks in order to exchange master data.

   For more information about master data import use cases and success or failure scenarios, see FAQ's page.

Export and download a CSV file with product master data.

1. Select the Main Menu icon.
2. Select Master Data in the main menu.
3. Select Product from the left menu.
4. Select Products from the left menu.
5. Select the Export button to generate and export the product master data file.

   A notification displays when the file is ready, and the file downloads automatically.

   See the information that displays in the element headers of the CSV file.

   • Primary Item Code Value – The value associated with the selected Primary Item Code Type. Used to uniquely identify each product record across all rows.

   • Primary Item Code Type – The type of identifier paired with the value to form the unique product record key.

   • Item Code Value – The value associated with the Item Code Type. Used with Item Code Type and Is Primary in the item code array. At least one complete row must be provided per product.

   • Item Code Type – The type of item identifier associated with the item code value.

   • Item Code Is Primary – Indicates whether the item code is the primary one. Values must be Yes or No. Only one item code per product should be marked as primary.

   • Item Code Action – Specifies whether the item code entry for that record should be deleted; when set (for example, to Delete), it removes that specific item code row from the record.

   • Product Group Code – Code used to group related products for classification or reporting purposes.

   • Data Status – Indicates the lifecycle status of the product. Allowed values: Active or Inactive. Required in the first row of each product record.

   • Item Status – Indicates the commercial availability status of the product. Required in the first row of each product record.

   • Effective Date – Date on which the product record becomes effective in the system.

   • Target Market Country – Country where the product is marketed or regulated.

   • Target Market Product Type – Classification of the product type for the specified target market.

   • Target Market Point of Dispense Verification – Indicates whether point-of-dispense verification is required in the target market.

   • Target Market Traceability Required – Indicates whether traceability is required for the product in the target market.

   • Target Market Product Origin – Country or region where the product originates for the target market.

   • Target Market Scheduled Drug – Indicates whether the product is classified as a scheduled drug in the target market.

   • Target Market PCID – Product category or classification identifier used in the target market.

   • Target Market Product Category Identifier – Identifier used to classify the product category in the target market.

   • Target Market Reporting Item Code Value – Item code value used for regulatory or compliance reporting in the target market.

   • Target Market Reporting Item Code Type – Item code type paired with the reporting item code value.

   • Target Market Marketing Authorization Number – Marketing authorization or approval number issued by the regulatory authority.

   • Target Market Registration Classification – Regulatory registration classification assigned to the product.

   • Target Market Prescription Drug Type – Prescription drug classification applicable in the target market.

   • Target Market Manufactured By – Name of the organization that manufactures the product for the target market.

   • Target Market Production Type – Type of production process used for the product in the target market.

   • Target Market MAH ID Value – Identifier value for the Marketing Authorization Holder in the target market.

   • Target Market MAH ID Type – Identifier type associated with the MAH ID value.

   • Target Market CMO ID Value – Identifier value for the Contract Manufacturing Organization.

   • Target Market CMO ID Type – Identifier type associated with the CMO ID value.

   • Target Market Virtual CMO ID Value – Identifier value for the virtual CMO.

   • Target Market Virtual CMO ID Type – Identifier type associated with the virtual CMO ID value.

   • Target Market Distribution Partner ID Value – Identifier value for the distribution partner in the target market.

   • Target Market Distribution Partner ID Type – Identifier type associated with the distribution partner ID value.

   • Target Market MAH Internal Material Code – Internal material code used by the MAH for the product.

   • Target Market CMO Internal Material Code – Internal material code used by the CMO for the product.

   • Target Market VCMO Internal Material Code – Internal material code used by the virtual CMO.

   • Target Market License for Permanent Import – License number authorizing permanent import into the target market.

   • Target Market License for Permanent Import End Date – Expiration date of the permanent import license.

   • Target Market License for Temporary Import End Date – Expiration date of the temporary import license.

   • Target Market Importer ID Value – Identifier value for the importer in the target market.

   • Target Market Importer ID Type – Identifier type associated with the importer ID value.

   • Target Market Repackaging License Number – License number authorizing repackaging activities.

   • Target Market Repackaging License Number End Date – Expiration date of the repackaging license.

   • Target Market Repackager ID Value – Identifier value for the repackager.

   • Target Market Repackager ID Type – Identifier type associated with the repackager ID value.

   • Target Market Action – Specifies whether the target market entry for that record should be deleted; when set (for example, to Delete), it removes that specific target market row from the record.

   • Export Market Export from Country – Specifies the country from which the product is authorized or configured to be exported.

   • Export Market Export to Country – Specifies the destination country to which the product is authorized or configured to be exported.

   • Export Market Unit Price – Unit price of the product for export transactions.

   • Export Market Currency Code – Currency code used for export pricing.

   • Export Market Target Market Exemption – Indicates whether a regulatory exemption applies in the export market.

   • Export Market Export Country Exemption Code – Code identifying the applicable export exemption.

   • Export Market Exemption Reference – Reference identifier for the export exemption.

   • Export Market Exemption Date – Date on which the export exemption is effective.

   • Export Market Manufactured By – Name of the manufacturer for exported products.

   • Export Market Manufacturer ID Value – Identifier value for the export market manufacturer.

   • Export Market Manufacturer ID Type – Identifier type associated with the manufacturer ID value.

   • Export Market Action – Specifies whether the export market entry for that record should be deleted; when set (for example, to Delete), it removes that specific export market row from the record.

   • Item Information Product Code – Product code associated with the item information record.

   • Item Information Language Code – Language used for item information content.

   • Item Information Product Description – Description of the product.

   • Item Information Drug Composition – Active ingredients or composition of the drug product.

   • Item Information Remarks – Additional notes or remarks about the product.

   • Item Information Product Name – Name of the product.

   • Item Information Generic Name – Generic or non-proprietary name of the product.

   • Item Information Manufacturer – Name of the product manufacturer.

   • Item Information Manufacturer ID Value – Identifier value for the manufacturer.

   • Item Information Manufacturer ID Type – Identifier type associated with the manufacturer ID value.

   • Item Information Strength – Strength or concentration of the product.

   • Item Information Dosage Form – Dosage form of the product.

   • Item Information EMVS Dosage Form – EMVS-compliant dosage form value.

   • Item Information Container Size – Size of the product container.

   • Item Information EMVS Pack Code – EMVS-compliant packaging code.

   • Item Information Minimum Temperature – Minimum storage temperature for the product.

   • Item Information Maximum Temperature – Maximum storage temperature for the product.

   • Item Information Temperature Scale – Temperature scale used for storage limits.

   • Item Information Sensitive to Light – Indicates whether the product is sensitive to light.

   • Item Information Market Dosage Form – Market-specific dosage form description.

   • Item Information Shelf Life – Shelf life duration of the product.

   • Item Information Shelf Life Unit – Unit of measure for the shelf life value.

   • Item Information Action – Specifies whether the item information entry for that record should be deleted; when set (for example, to Delete), it removes that specific item information row from the record.

   • Packaging Information Packaging Code Value – Value of the packaging code used to identify the packaging level.

   • Packaging Information Packaging Code Type – Type of packaging code associated with the packaging code value.

   • Packaging Information Packaging Level – Packaging hierarchy level represented by the packaging code.

   • Packaging Information Container Aggregation Quantity – Quantity of items aggregated within the container.

   • Packaging Information Packaging Ratio – Ratio defining the relationship between packaging levels.

   • Packaging Information Batch Size Maximum – Maximum allowable batch size for the packaging configuration.

   • Packaging Information Batch Size Acceptable – Acceptable batch size for the packaging configuration.

   • Packaging Information Batch Size Minimum – Minimum allowable batch size for the packaging configuration.

   • Packaging Information Serialization Type – Serialization method applied to the packaging level.

   • Packaging Information Requires Aggregation – Indicates whether aggregation is required for the packaging level.

   • Packaging Information Filter Value – Filter value used to control packaging configuration applicability.

   • Packaging Information GS1 Company Prefix – GS1 company prefix used to generate packaging identifiers.

   • Packaging Information Code Version – Version of the packaging code standard used.

   • Packaging Information Code Level – Code level associated with the packaging hierarchy.

   • Packaging Information Data Status – Lifecycle status of the packaging information record.

   • Packaging Information Action – Specifies whether the packaging information entry for that record should be deleted; when set (for example, to Delete), it removes that specific packaging information row from the record.

   • Item Information Language Code – Specifies the language of the item information. Required if any item information field is populated.

1. Select the Main Menu icon.
2. Select Master Data in the main menu.
3. Select Product from the left menu.
4. Select Products from the left menu.
5. Select the Filter button to find the product.

6. Fill in one or more of the following fields to filter the results:

   1. Product Name field – The name of this Product.
   2. Description field – The product descriptions which typically includes the product name, dosage, form, and the number of doses.
   3. Status drop-down – The status of the Product information within TraceLink:
      • Select All – Both Active and Inactive data are selected and included for use.
      • Active – The data can be used in messages and UI functions, and TraceLink leverages the data when necessary.
      • Inactive – The data cannot be used for other functions within TraceLink.
   4. Item Code field – The item code used for this product.
   5. Packaging Code field – The serial numbers for the product are generated according to the packaging code type. If necessary, define a packaging code for each Packaging Level that needs to be tracked.
   6. MAH ID - The identifier assigned to the Marketing Authorization Holder (MAH) for regulatory purposes.
   7. Manufacturing CMO ID - The identifier assigned to the Contract Manufacturing Organization (CMO) responsible for product manufacturing.
   8. Last Updated drop-down – Specifies the date the transaction was last processed or updated.

7. Select Apply.

   The results display in the table.

8. Select the Name hyperlink in the results table.

9. Select the Edit button.

10. In the Product information section, update the Product Group Code, Effective Date, Status, and Item Status fields.

11. Select the Add icon in the Item Codes section and fill in the following fields:
    1. Item Code Type drop-down – The item code used for this product. Each item code type can only be used once for each product, except for internal material number.
    2. Item Code Value field – The value associated with the item code. The value must be unique within the Item Code Type, and special characters (e.g. -, ., /. \) are removed from this value.

    3. Primary Item Code switch – Required. The primary item code used for this product. Each company must have at least one identifier type and value combination. One identifier must be designated as the primary identifier, and only one primary identifier is allowed per company. TraceLink uses the primary identifier to match future updates or imports to the correct entity in the TraceLink Network.

       • Yes – The primary item code for this product.
       • No – The item code is not the primary item code for this product.
    4. Select Apply.

       The new item code is added to the Item Codes table.
       

    5. Select the Add icon in the Item Codes section to add another Item Code Type drop-down and Item Code Value field.

12. Select the Add icon in the Target Markets section and fill in the following fields:
    1. Country Market Code drop down - Required. The market code associated with the country. Select the Add icon to add another identifier Country Market Code.
    2. Product Type drop-down – The type of product
       • Prescription Drug – A prescription medicine.
       • Medical Device – A medical device.
       • OTC Drug – An over the counter product.
       • Nutritional Product – A nutritional product.
       • Derivative Product – A derivative product.
       • Bulk Pharmaceutical – A bulk pharmaceutical product.
       • Food Supplement – A nutritional product.
       • Medical Product – A medical product.
    3. Prescription Drug Type drop-down – Specifies whether the medicine is available by prescription only:
       See the information that displays on the Prescription Drug Type

       • Anabolic steroid – An anabolic steroid prescription product.
       • Antiretroviral – An antiretroviral prescription product.
       • Controlled plant – A controlled plant prescription product.
       • Immunosuppressive – An immunosuppressive prescription product.
       • Narcotic – A narcotic prescription product. It is applicable if the target market for this product is India.
       • Other – A prescription product that does not fall into another category. It is applicable if the target market for this product is India.
       • Pharmaceutical precursor chemical – A pharmaceutical precursor chemical prescription product.
       • Prohibited Substance – A prohibited substance prescription product.
       • Psychoactive anorectic – A psychoactive anorectic prescription product. It is applicable if the target market for this product is India.
       • Psychoactive anti-anxiety – A psychoactive anti-anxiety prescription product. It is applicable if the target market for this product is India.
       • Psychoactive anti-epileptic – A psychoactive anti-epileptic prescription product. It is applicable if the target market for this product is India.
       • Psychoactive anti-psychotic – A psychoactive anti-psychotic prescription product. It is applicable if the target market for this product is India.
       • Psychoactive mood stabilizer – A psychoactive mood stabilizer prescription product. It is applicable if the target market for this product is India.
       • Psychoactive sleep inducer – A psychoactive sleep inducer prescription product. It is applicable if the target market for this product is India.
       • Psychoactive stimulant – A psychoactive stimulant prescription product. It is applicable if the target market for this product is India.
       • Psychoactive antidepressant – A psychoactive antidepressant prescription product. It is applicable if the target market for this product is India.
       • Radioactive – A radioactive prescription product.
       • Retinoid – A retinoid prescription product.
       • Toxic drug for medical use – A toxic medical prescription product.
    4. Traceability Required switch – Specifies whether the product legally needs to be traced through the pharmaceutical supply chain:
       • Required – The product requires tracking.
       • Not Required – The product is exempt from tracking.
    5. Scheduled Drug drop-down – Specifies 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.
    6. Product Image field – The image of the product. Drag and drop a file to upload or select the browse link to upload the image.
    7. Reporting Item Code Value section – The reporting item code for this target market.
       • Type drop-down – The product's Item code that is used in a specific target market instead of the target market's default Item Code for compliance reporting.
       • Value field – The reporting item code value for this target market.
       • Marketing Authorization Number field – The product’s authorization number issued by a government agency.
       • Product Category Identifier field – The commodity tariff code that classifies the product when determining its customs value.
       • Registration Classification drop-down – The product classification at the time of registration:
         • Patent Medicine – The product is classified as a patented medicine.
         • Chemical – The product is classified as chemical.
         • Biological – The product is classified as biological.
       • Point of Dispense Verification switch – Specifies whether the product has a point of dispense verification requirement:
         • Required – The product has a point of dispense verification requirement.
         • Not Required – The product does not have a point of dispense verification requirement.
       • Product Origin drop-down – Specifies how the product was sourced by the company selling the product:
         • Direct Purchase from Exclusive Distributor – The company acquires the product as a direct purchase from the exclusive distributor of the manufacturer.
         • Direct Purchase from Manufacturer – The company acquires the product as a direct purchase from the manufacturer
         • Direct Purchase from Repackager – The company acquires a product as a direct purchase from a repackager who purchased directly from the manufacturer.
         • Indirect Purchase – The company acquires a product as an indirect purchase from a supplier or repackager that did not acquire the product directly from the manufacturer.
         • Originator (Manufactuer) – The company is the manufacturer of the product and sells the product into the supply chain.
         • Originator Exclusive Distributor – The company that purchased the product is the exclusive distributor of the product.
       • PCID field – The medicinal product package identifier (i.e. PCID) that determines the EU Hub's Article 57 Code on master data compliance reports.
       • Production Type drop-down – Specifies where the product is manufactured relative to the country defined in the Target Market:
         • Locally Manufactured – The company manufactures the product 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 - The company manufactures the product in the target market.
       • Manufactured By drop-down – The type of organization manufacturing the product:
         • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
         • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
    8. MAH ID:
       • Type drop-down – Required. Conditionally required if MAH is selected in the Manufactured By field. The company or location identifier of the MAH, which must exist in Company or Partner Master Data. If the Target Market is in India, this value must be the GS1 Company Prefix.
       • Value field – Required. The value associated with the MAH ID. The value must be unique within the MAH ID Type and special characters (e.g. -, ., /. \) are removed from this value.
       • MAH Internal Material Code field – The Internal Material Code used by the MAH for the product.

    9. Manufacturing CMO ID:

       • Type drop-down – Required. The company ID for the CMO manufacturing the product.
       • Value field – Required. The value associated with the Manufacturing CMO ID Type. The value must be unique within the Manufacturer CMO ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
       • CMO Internal Material Code field – The Internal Material Code used by the CMO that manufactured the product.

    10. Virtual CMO Identifier

        Type drop-down – Required. The Internal Material Code used by the Virtual CMO for the product.
        • Value field – Required. The value associated with the Virtual CMO ID. The value must be unique within the Virtual CMO ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
        • VCMO Internal Material Code field – The Internal Material Code used by the Virtual CMO that manufactured the product.
    11. License for Permanent Import:
        • License Number field – The license number granted to import product that cannot be exported and will remain in the country permanently.
        • Expiration Date field – The date on which the License for Permanent Import expires.
    12. License for Temporary Import:
        • License Number field – The license number granted to import product that cannot be exported and will remain in the country temporarily.
        • Expiration Date field – The date on which the License for Temporary Import expires.
    13. Importer ID:
        • Type drop-down – The identifier type and value of the company that is importing the product into the Target Market.
        • Value field – The value associated with the Importer ID. The value must be unique within the Importer ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
    14. Repackaging License:
        • License Number field – The repackager license number.
        • Expiration Date field – The date when the repackaging license number expires (YYYY-MM-DD format).
    15. Repackager ID:
        • Type drop-down – Required. The identifier type and value of the company that repackages the product.
        • Value field – Required. The value associated with the Repackager ID. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
13. Select the Add icon in the Export Market section and fill in the following fields:
    1. Export Market:
       • Export from Country drop-down – The country where the exported products are being shipped from. The country is identified using the standard two- or three-letter abbreviation specified in ISO 3166-1alpha-2:1997 country code.
       • Export to Country drop-down – The country where the exported products are being received. The country is identified using the standard two- or three-letter abbreviation specified in ISO 3166-1alpha-2:1997 country code.
       • Unit Price field – The price per unit of the product in the target market. If a unit price is entered and the country manufacturer is IN (India), the value must be a number from 0.50 – 9999999.99.
       • Currency Code drop-down – Conditionally required if the Unit Price is specified. The currency code for the product's unit price in ISO 4217:2015 format.
       • Manufactured By drop-down – The type of organization manufacturing the product:
         • CMO – (Contract Manufacturer Organization) The company contracts a third-party organization to manufacture the product for this Target Market.
         • MAH – (Marketing Authorization Holder) The company is registered as the product's MAH for this Target Market.
       • Type drop-down – Required. The identifier type and value of the company that repackages the product.
       • Value field – Required. The value associated with the Repackager ID. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
2. Manufacturer ID:
   • Type drop-down – Required. The type of identifier used for this manufacturer.
   • Value field – The value associated with the Manufactuer ID. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
   • Target Market Exemption switch - if the product is exempted from regulatory compliance in the Export to Country field.
     • True – The product is exempted from regulatory compliance.
     • False – The product is not exempted from regulatory compliance.
   • Export Country Exemption Code drop-down – The exemption category code for exempted product with enumeration values in India:
     • 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 the requirements in India.
   • Exemption Reference field – The name of the law or regulation in the destination country for which the exporter has obtained exemption permission.
   • Exemption Date field – The date the exemption request has been granted to the exporter by the governing agency of the destination country (can be the date of the published law).

Select the Add icon in the Item Information Details section.

1. Item Information:
   • Language Code drop-down - The language code.
   • Product Description field – Required. The product description, which includes the product name, dosage, form, and the number of doses.
   • Product Code field – The regulatory product code associated with the product in China, or an additional product code in other target markets.
   • Product Name field – Required. The name of the medicine that is displayed on the product label.
   • Generic Name field – The chemical or non-proprietary name of the product. The generic name describes the chemical make up (atomic or molecular structure) of the product in contrast to the brand name that is used to market it.
   • Manufacturer field – Required. The name of the manufacturer as it appears on the product label.
2. Manufacturer ID:

   • Type drop-down – The ID for the manufacturer or re-packager of the product as it appears on the product label (e.g. GLN 123412341).

   • Value drop-down - The ID Value for the manufacturer or re-packager of the product.
   • Strength field – The strength of the product (e.g. 100 mg).
   • Drug Composition field – The chemical composition of the product. The maximum character length is 500 characters if the Target Market is in India.
   • Dosage Form field – The dosage form of the product (e.g. tablet, capsule).
   • EMVS Dosage Form drop-down – The form the product is dispensed in according to the EU's standard set of values.
   • Market Dosage Form drop-down – The form the product is dispensed according to a specific Target Market's set of values.
   • Container Size field – The number of individual doses in the pack.
   • EMVS Pack Code drop-down – The way the product is packaged to be sold according to the EU's standard set of values.
   • Remarks field – Product-related instructions or comments not described in the previous fields.
   • Minimum Temperature field – The coldest temperature the product can be exposed without compromising its quality and safety. If the Maximum Temperature and Minimum Temperature values are both provided, the Minimum Temperature must be less than or equal to the Maximum Temperature value.
   • Maximum Temperature field – The hottest temperature the product can be exposed to without compromising its quality and safety. If the Maximum Temperature and the Minimum Temperature values are both provided, the Maximum Temperature value must be greater than or equal to the Minimum Temperature value.
   • Temperature Scale drop-down – Conditionally required if either Minimum Temperature or Maximum Temperature are present. The temperature scale that the Minimum Temperature and Maximum Temperature are entered in:
     • Celsius
     • Farenheit
     • Kelvin
   • Sensitive to Light switch – whether exposure to light can compromise the product's quality and safety
     • 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.
   • Shelf Life – Specifies the length of time that a product remains consumable. The value must be a number between 1-9999:
     • Shelf Life Value field - The value of the shelf-life.
     • Shelf Life Unit drop-down:
       • Days – The shelf-life value is provided in days.
       • Months – The shelf-life value is provided in months.
       • Years – The shelf-life value is provided in years.

Select the Add icon in the Packaging Information Details section and fill in the following fields:

2. Packaging Code:
   • Packaging Code Type drop-down – Required. The serial numbers for the product are generated according to the packaging code type. If necessary, define a packaging code for each Packaging Level that needs to be tracked:
     • 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).Product Name field – Required. The name of the medicine that is displayed on the product label.
   • Packaging Code Value field – The value associated with the Packaging Code Type. The value must be unique within the Repackager ID Type, and special characters (e.g. -, ., /. \) are removed from this value.
   • Packaging UOM drop-down - Required. The unit of measure used for the packaging level (e.g., Each, Bundle, Case).
   • Container Aggregation Quantity field – The number of children contained in this level of shipment. (e.g. For a Case, the Container Aggregation Quantity lists the number of Inner Packs contained in each Case.):
   • Packaging Ratio field – Conditionally required if the Packaging Code Type is CN-ResCode. 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).

     TraceLink only uses this field for compliance reporting purposes, not validation during aggregation.

   • Batch Size Maximum field – The maximum batch size that is acceptable for the product. This field is only used when the value of Packaging Level is EACH.
   • Batch Size Acceptable field - The acceptable batch size acceptable for the product.
   • Batch Size Minimum field - The minimum batch size acceptable for the product.
   • Serialization Type drop-down – The type of serialization required for the packaging code:
     • None – No serialization.
     • Random – Random serialization.
     • Sequential – Sequential serialization.
   • Requires Aggregation drop-down – Specifies if each Packaging Level requires serial numbers:
     • Aggregated – Each Packaging Level requires serial numbers.
     • Not Aggregated – Not every Packaging Level requires serial numbers.
   • Filter Value field – drop-down. 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. The numeric values must be between 0-7.
   • GS1 Company Prefix field – Conditionally required if the Packaging Code Type is GTIN-14. The prefix is included in the packaging code and it is assigned by the GS1 organization.

     TraceLink uses this prefix to convert serial numbers in barcode format to the EPC URN format used in EPCIS messages.

   • Code Version field – Conditionally required if the Packaging Code Type is CN-ResCode. The product code version number (e.g. 81, 88).
   • Code Level field – Conditionally required if the Packaging Code Type is CN-ResCode. The packaging level associated with this ResCode. The numeric values must be between 1-9 with the innermost packaging level.
   • Is Active switch - Indicates whether this specific packaging configuration is currently in use.

     • Active – The packaging information is enabled and used in TraceLink processes.

     • Inactive– The packaging information is disabled and excluded from TraceLink workflows.

16. Select the Save button.

    The product information, item codes, target markets, export markets, item information, and packaging information are saved to the Product details.

Tips

• In the Item Codes, Target Markets, Export Markets, Item Informationand Packaging Information sections, do one of the following:

  • Select the Add icon to add the a new item code, target market, export market, item information, and packaging information.

  • Select the Remove icon to delete an item code, target market, export market, item information, and packaging information.

  • Select the Edit icon to edit an item code, target market, export market, item information, and packaging information.

  Use the same icons available at the top of the screen to perform these actions.

For information about viewing the product export files, go to the View All Import and Export Files page.