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Applications

Russia Compliance is a TraceLink application that allows Owners to generate and exchange compliance reports with Markirovka (MDLP), which is Russia's national reporting system.

Owners can search and view:

  • Compliance reports generated in TraceLink and submitted to MDLP.
  • Notifications generated by MDLP and sent to the Owner's company.

Owners (e.g. Marketing Authorization Holders) use the Russia Compliance application to meet the reporting requirements of Federal Law No. 425-FZ. The Russia Compliance application generates reports for regulated products as they move through the supply chain and displays those reports in the Web UI. Additionally, Russia Compliance connects to MDLP to distribute reports and receive the notifications that MDLP generates.

Russia Crypto Codes is a TraceLink application that allows Marketing Authorization Holders (MAHs) to obtain crypto codes (i.e. encrypted identification numbers) from Russia's Tsentr Razvitiya Perspektivnykh Tekhnologiy Order Management Station (CRPT OMS).

The Russia Crypto Codes application works with Serial Number Manager and Serial Number Exchange to supply locations with crypto codes associated with provisioned serial numbers. Additionally, the Russia Crypto Codes Web UI provides visibility into crypto code orders.

MAHs and CMOs use the Russia Crypto Codes application to comply with Russia's crypto code requirement.

Russia requires every serial number to have an associated encrypted identification number (crypto code), which consists of a "key" and a "code." This provides additional security and allows pharmacies without internet access to verify products.

Crypto codes are generated and managed by Tsentr Razvitiya Perspektivnykh Tekhnologiy (CRPT), which is a public-private organization in Russia. Companies request crypto codes from CRPT using its Order Management Station (OMS).

Compliance reports

Compliance reports for Russia can be generated in the following ways:

  • Automatically, by enabling workflows in Company Administration:

    When the appropriate workflows are enabled, the Russia Compliance application generates reports when certain events occur in TraceLink (e.g. when a product release occurs in Serialized Operations Manager). See Generate compliance reports for a list of supported Russia Compliance report types, and select the name of a report to view the events and conditions that generate it.

  • On demand, by generating the report in Serialized Operations Manager:

    Russia Compliance Owners can identify the serialized items to create the report for in Serialized Operations Manager. This option is useful if a report failed to generate automatically, and the information must still be submitted to MDLP.

    All report types can be generated on demand in Serialized Operations Manager, except for the 701 - Accept report in response to a 614 - Foreign Import Notification. Russia Compliance Owners generate this report type on demand using the Russia Compliance Web UI.

Yes. Compliance reports can be generated as needed in Serialized Operations Manager, under Event Workflow Management. This option is useful if a report failed to generate automatically, and the information must still be submitted to MDLP.

All report types can be generated on demand in Serialized Operations Manager, except for the 701 - Accept report in response to a 614 - Foreign Import Notification. Russia Compliance Owners generate this report type on demand using the Russia Compliance Web UI.

To generate a report on demand

  1. Hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Event Workflow Management drop-down, and then select the link with the name of the report to generate (e.g. Generate Russia 331 - Foreign Shipment Report).

    To generate the 911 - Unit Pack, 914 - Unit Append, or 913 - Unit Extract reports, select Generate Russia Aggregation and Disaggregation Reports.

  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Fill in the fields, depending on the type of event that must be reported:

    Enter the Delivery Number associated with the event.

    1. Enter the product's Packaging Code.
    2. Enter the Lot Number to identify the serial numbers for the report.

    Enter the Serial Numbers to include in the report by selecting one of the following:

    • Select Upload Serial Numbers from File:
      1. Select Choose File.
      2. Browse for and select the desired CSV file.
        3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

      or

    • Select Scan Serial Numbers:
      • Enter the serial numbers (limit of 30,000 characters).

        or

      • Scan the serial numbers (limit of 30,000 characters) with an external scanner.
    1. Select the Report Type to generate:
      • Aggregate (911 - Unit Pack or 914 - Unit Append) – Generates the 911 - Unit Pack or 914 - Unit Append reports, depending on which report MDLP is prepared to accept.
      • Disaggregate (913 - Unit Extract) – Generates the 913 - Unit Extract report.
    2. If the Report Type is Aggregate, enter the parent SSCC that the items are aggregated to in the Container Serial Number field.
    3. Enter the Serial Numbers to report as aggregated or disaggregated by selecting one of the following:
      • Select Upload Serial Numbers from File:
        1. Select Choose File.
        2. Browse for and select the desired CSV file.
          3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

        or

      • Select Scan Serial Numbers:
        • Enter the serial numbers (limit of 30,000 characters).

          or

        • Scan the serial numbers (limit of 30,000 characters) with an external scanner.

      Include only the serial numbers to aggregate or disaggregate, rather than all children within the container.

    1. Enter the identifier of the customs agency that performed the clearance in the Customs Authority Code field.
    2. Enter the identifier that the customs agency assigned to the items to indicate that they are approved for release in the Customs Declaration Release Number field.
    3. Enter the date that the shipment was registered with customs in the Registration Date field.
  5. Select Submit.

    The screen refreshes and TraceLink begins generating the report.

Russia Compliance Owners view generated compliance reports and notifications from MDLP in the Russia Compliance Web UI.

To view compliance reports and notifications

  1. Hover over Modules, and then select Russia Compliance.
  2. Select Compliance Reports.

    A table displays with all available compliance reports and notifications, other than the 911 - Unit Pack, 913 - Unit Extract, and 914 - Unit Append reports, which Owners must search for.

  3. Search for reports and notifications (optional):
    1. Select the Search icon on the left if the search fields do not display.
    2. Select the Report Type to search for.

      To search for the 911 - Unit Pack, 913 - Unit Extract, and 914 - Unit Append reports, select Aggregation and Disaggregation.

    3. Select the Status of the report or notification:
      • Generated – The report is created in TraceLink.
      • Submitted – The report is sent to MDLP.
      • Retrying – The report is sent to MDLP, but MDLP initially rejected it. After MDLP rejects the report for the first time, TraceLink parks the submission for 30 minutes and then retries the submission, adding the parked time to the operation_date in the report so that MDLP recognizes the retried report as unique and does not reject it as a duplicate. If MDLP rejects the report again after the first retry, TraceLink parks and retries the submission for another 30 minutes, at which point MDLP moves the report to the Accepted, Rejected, or Partial status.
        TraceLink does not retry the 911 - Unit Pack, 913 - Unit Extract, and 914 - Unit Append reports if they are generated as the result of a SOM Aggregation Update event.
      • Accepted – MDLP received the report successfully and accepted the information.
      • Rejected – MDLP received the report successfully, but rejected the information.
      • Failed – The OMS received the report successfully, but rejected the information. This status is applicable to only the OMS Domestic Utilisation and OMS Foreign Utilisation reports, which TraceLink submits to the OMS and the OMS then submits to MDLP.
      • Partial – MDLP received the report successfully, but accepted only some of the information.
      • Received – The notification from MDLP is received in TraceLink.
    4. Enter the name and location of the Owner company that initiated the report in the Company - Location field.
    5. Enter the Date Range to search:
      • Start – Reports generated on or after this date.
      • End – Reports generated on or before this date.
    6. Enter the GTIN Packaging Code of the serialized items in the report. Format is [Packaging Code Type] [Packaging Code Value].
    7. Enter the Lot Number associated with the serial numbers in the report.
    8. Enter the MDLP document ID associated with the report in the Report ID field.
    9. Select Search.

      The results display in the table.

      • Location – The location of the Owner company that initiated the report.
      • Delivery Number – The delivery number included in the report, if applicable.
      • Packaging Code – The GTIN packaging code of the serialized items in the report.
      • Description – A description of the product in the report, sourced from Product Master Data.
      • Report Type – The type of Russia Compliance report.
      • Report Date – The date that the report was generated.
      • Status – The status of the report:
        • Generated – The report is created in TraceLink.
        • Submitted – The report is sent to MDLP.
        • Retrying – The report is sent to MDLP, but MDLP initially rejected it. After MDLP rejects the report for the first time, TraceLink parks the submission for 30 minutes and then retries the submission, adding the parked time to the operation_date in the report so that MDLP recognizes the retried report as unique and does not reject it as a duplicate. If MDLP rejects the report again after the first retry, TraceLink parks and retries the submission for another 30 minutes, at which point MDLP moves the report to the Accepted, Rejected, or Partial status.
          TraceLink does not retry the 911 - Unit Pack, 913 - Unit Extract, and 914 - Unit Append reports if they are generated as the result of a SOM Aggregation Update event.
        • Accepted – MDLP received the report successfully and accepted the information.
        • Rejected – MDLP received the report successfully, but rejected the information.
        • Failed – The OMS received the report successfully, but rejected the information. This status is applicable to only the OMS Domestic Utilisation and OMS Foreign Utilisation reports, which TraceLink submits to the OMS and the OMS then submits to MDLP.
        • Partial – MDLP received the report successfully, but accepted only some of the information.
        • Received – The notification from MDLP is received in TraceLink.
      • Lot Number – The lot or batch number associated with the serial numbers in the report.
      • Quantity – The quantity of serial numbers in the report.
      • Report ID – The report's MDLP document ID.

Tips

  • Select the View Report icon in the Actions column to view details about the report.
  • Select the Message History icon in the Actions column to view the Info Exchange message that contains the report.

    See the Info Exchange Online Help for more information.

  • Select the Reprocess icon in the Actions column for a Report Type of 601 - Move Order Notification or 603 - Move Owner Notification to retry creating an Unsubmitted Receipt with the notification's serial numbers in Serialized Operations Manager.

    Only users assigned a role with Full Access for the Reprocess Inbound Delivery for 601 - Move Order Notification or Reprocess Inbound Delivery for 603 - Move Owner Notification permission can reprocess the 601 - Move Order Notification or 603 - Move Owner Notification reports respectively.

  • Select the Reprocess icon in the Actions column for a Report Type of 614 - Foreign Import Notification to retry generating a 701 - Accept report in response to the notification. See Troubleshoot a problem for more information.

    Only users assigned a role with Full Access for the Reprocess Inbound Delivery for 614 - Foreign Import Notification permission can reprocess the 614 - Foreign Import Notification report.

Use a report's Status to track its transmission from TraceLink to MDLP:

  • Generated – The report is created in TraceLink.
  • Submitted – The report is sent to MDLP.
  • Retrying – The report is sent to MDLP, but MDLP initially rejected it. After MDLP rejects the report for the first time, TraceLink parks the submission for 30 minutes and then retries the submission, adding the parked time to the operation_date in the report so that MDLP recognizes the retried report as unique and does not reject it as a duplicate. If MDLP rejects the report again after the first retry, TraceLink parks and retries the submission for another 30 minutes, at which point MDLP moves the report to the Accepted, Rejected, or Partial status.
    TraceLink does not retry the 911 - Unit Pack, 913 - Unit Extract, and 914 - Unit Append reports if they are generated as the result of a SOM Aggregation Update event.
  • Accepted – MDLP received the report successfully and accepted the information.
  • Rejected – MDLP received the report successfully, but rejected the information.
  • Failed – The OMS received the report successfully, but rejected the information. This status is applicable to only the OMS Domestic Utilisation and OMS Foreign Utilisation reports, which TraceLink submits to the OMS and the OMS then submits to MDLP.
  • Partial – MDLP received the report successfully, but accepted only some of the information.
  • Received – The notification from MDLP is received in TraceLink.

Information requests

Yes. The Information Requests screen in the Russia Compliance application allows Owners to asynchronously request the following information from MDLP:

  • The GTIN, lot number, expiration date, status, and parent SSCC of an SGTIN serial number.
  • The child serial numbers contained within a parent SSCC.

Requesting information from MDLP allows Owners to confirm that the information on record with MDLP matches the information in TraceLink and take action, if needed (e.g. submit a compliance report).

TraceLink submits information requests to MDLP using the outbound 210 - Query Kiz Info message and MDLP returns the information to TraceLink using the inbound 211 - Kiz Info message. See the Info Exchange Online Help for more information.

  1. Hover over Modules, and then select Russia Compliance.
  2. Select Information Requests.
  3. Select Serial Number Information.

    The Request Serial Number Information dialog displays.

  4. Enter the SGTIN Serial Number to request information about.
  5. Select Submit.

    The dialog closes. TraceLink confirms that the specified serial number is an SGTIN and asynchronously submits the information request to MDLP. The GTIN, lot number, expiration date, status, and parent SSCC of the serial number are available when MDLP returns the information to TraceLink.

  1. Hover over Modules, and then select Russia Compliance.
  2. Select Information Requests.
  3. Select Aggregation Information.

    The Request Aggregation Information dialog displays.

  4. Enter the SSCC Container Serial Number with the packaging hierarchy to request from MDLP.
  5. Select Submit.

    The dialog closes. TraceLink confirms that the specified container serial number is an SSCC and asynchronously submits the information request to MDLP. The child serial numbers for the container are available when MDLP returns the information to TraceLink.

Crypto codes

  • Companies that use TraceLink Serial Number Manager to generate serial numbers use the Russia Crypto Codes application to request crypto codes from the CRPT Order Management Station (OMS). When Serial Number Manager generates serial numbers, the Russia Crypto Codes application submits those serial numbers to the OMS as part of a crypto code request. The OMS then generates crypto codes associated to each serial number and returns the crypto codes to TraceLink.
  • Companies that receive serial numbers from an external system (e.g. a CMO that receives serial numbers from their MAH, or an MAH that uses an external serial number manager) rely on that external system to request crypto codes from the OMS. TraceLink expects to receive both serial numbers and their associated crypto codes from the external system.

Locations that use crypto codes always receive serial numbers and crypto codes at the same time. When a location that uses crypto codes requests serial numbers, TraceLink makes those serial numbers available to locations for provisioning (i.e. moves the serial numbers to the Unreserved state) only after obtaining their associated crypto codes.

Russia Crypto Codes Owners view crypto code orders in the Russia Crypto Codes Web UI.

To view crypto code orders

  1. Hover over Modules, and then select Russia Crypto Codes.

    A table displays with all available crypto code orders.

    Companies that receive serial numbers and crypto codes from an external system (e.g. a CMO that receives serial numbers from their MAH, or an MAH that uses an external serial number manager) see orders with the Fulfilled status only.

  2. Search for crypto code orders (optional):
    1. Select the Search icon on the left if the search fields do not display.
    2. Enter the Date Range to search:
      • Start – Reports generated on or after this date.
      • End – Reports generated on or before this date.
    3. Enter the GTIN packaging code of the serial numbers that the crypto codes are associated to.
    4. Enter the name or identifier of the entity or location that the crypto codes are Requested By.
    5. Enter the crypto code Order ID, generated by the CRPT OMS.
    6. Select the organization that the crypto codes are Provided By:
      • OMS – The CRPT Order Management Station (OMS).
      • MAH – Companies on the TraceLink Network that supply others with serial numbers and crypto codes (e.g. MAHs that provide serial numbers and crypto codes to their CMOs).
    7. If crypto codes are Provided By an MAH, enter the name or identifier of the MAH.

      Companies that use an external serial number manager to generate serial numbers and request crypto codes enter their company's name in this field.

    8. Select Search.

      The results display in the table.

      • Date – The date that the crypto code order was placed.
      • Order ID – The identifier of the crypto code order, generated by the CRPT OMS.
      • GTIN – The GTIN packaging code of the serial numbers that the crypto codes are associated to.
      • Description – A description of the product that the crypto codes are for, sourced from Product Master Data.
      • Requested By – The name of the entity or location that requested the crypto codes.
      • Provided By – The organization that TraceLink receives the crypto codes from:
        • OMS – The CRPT Order Management Station (OMS).
        • [Company Name] – The company on the TraceLink Network that supplies the serial numbers and crypto codes (e.g. an MAH that provides serial numbers and crypto codes to their CMO).
      • Status – The status of the crypto code order:
        • Submitted – The request for crypto codes has been submitted to the CRPT OMS.
        • Fulfilled – The crypto codes are available in TraceLink.
        • Error – An issue occurred after submitting a crypto code request to the CRPT OMS.
      • Quantity – The quantity of crypto codes in the order.

Tips

  • For orders with a status of Fulfilled, select the Download Order   icon in the Actions column of the results table to download crypto codes and their associated serial numbers as a CSV file.

    The downloaded file contains 2 columns. The first column displays the serial numbers, formatted as 01[GTIN]21[Serial Number] and the second column displays the crypto keys and crypto codes, formatted as (91)[Crypto Key](92)[Crypto Code].

  • For orders with a status of Error, select the Download Errors icon in the Actions column of the results table to download the errors raised by TraceLink and CRPT as a text file.

Each crypto code request has an associated Order ID. The CRPT Order Management Station (OMS) generates the Order ID after receiving a crypto code request, so the requesting company can monitor their order's status.

Companies that use TraceLink to generate serial numbers and request crypto codes can view their Order IDs on the Crypto Codes Orders screen.

Track & Trace Services

TraceLink supports the following browsers:

  • Google Chrome: The most recent stable version.
  • Mozilla Firefox: The most recent stable version.
  • Microsoft Internet Explorer: The most recent stable version; tied to the Microsoft Support Lifecycle.