342 - Release in Circulation

Russia Compliance owners generate the 342 - Release in Circulation report to capture the release of foreign product for circulation in the Russian market.

Configuring the report

  1. Hover over Company Administration on the User Profile in the top right of any screen, and then select Workflow.
  2. Select the Generate 342 - Release in Circulation Report Resulting Actions checkbox for the Product Status Set to Released to Market workflow Event.
  3. Select Save in the top left of the screen, above the results table.

    The screen refreshes, and the workflow is enabled.

The Russia Compliance application generates the 342 - Release in Circulation report when TraceLink processes a Product Status Set to Released to Market event and the following conditions are met in the interface where the event occurred:

  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM (unit of measure) of Each.
  • The products have a Target Market of Russia.
  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.

Use the following message to generate the 342 - Release in Circulation report:

  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.

Use the following message to generate the 342 - Release in Circulation report:

Generating the report

  1. Hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update Functions drop-down, and then select Set Market Release Status.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code field.
  5. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers to be released.
  6. Enter the 14-character Russia Account Number of the Location performing the market release, as entered in Product Master Data.
  7. Select Full Lot from the Scope radio buttons to indicate that the entire lot of product is being released into Russia.
  8. Specify the conformity documents for the product:
    1. Specify a State Confirmation document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select State Confirmation Number as the Identifier Type.
      3. Enter the Identifier Value of the State Confirmation document.
      4. Enter the Document Date printed on the State Confirmation document (optional if a Document Date is specified for a Civil Circulation document).
    2. Specify a Civil Circulation document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select Civil Circulation Release Number as the Identifier Type.
      3. Enter the Identifier Value of the Civil Circulation document.
      4. Enter the Document Date printed on the Civil Circulation document (optional if a Document Date is specified for a State Confirmation document).
    3. Specify additional conformity documents (optional):
      1. Select Add Another in the Transaction IDs table header.

      2. Specify a quality inspection document from the Identifier Type drop-down, which is used to certify that the product conforms to Russian legal, safety, and quality requirements.

      3. Enter the Identifier Value of the quality inspection document.
      4. Enter the Document Date printed on the quality inspection document.
  9. Enter the quantity of serial numbers commissioned at each packaging level of the lot in the Production Quantity table (optional):

    If a product is involved in a Commissioning or Aggregation event that is currently processing, TraceLink parks and retries the operation to verify the Production Quantity details for a given Lot Number before triggering any configured compliance reports.

    1. Identify items at the Each level:
      1. Select Add Level.
      2. Select the Each's GTIN, NTIN, or CN-Subtype identifier of the serial numbers assigned to the product's packaging level from the Packaging Code down-drop, as entered in Product Master Data.
      3. Enter the amount of serial numbers expected in the Packaging Level in the Quantity field.
    2. Identify items at another Packaging Level (optional):
      1. Select Add Level.
      2. Select a Packaging Level:
        • Each – The smallest salable unit a product can be serialized in.
        • Inner Pack/Bundle – Contains a group of eaches.

        • Case/Shipper – The next level of packaging. Contains a group of Inner Packs/Bundles.

          • SSCC – Enabled when Case/Shipper is selected.

            • If SSCC is selected, enter a GS1 Company Prefix in the Packaging Code field.
            • If SSCC is not selected, enter a GTIN, NTIN, or CN-ResCode in the Packaging Code field.
        • Pallet – The largest packaging level. Contains a group of Cases/Shippers.
      3. Select a Packaging Code.
      4. Enter the Quantity.
  10. Select Submit.

    The screen refreshes, and TraceLink takes one of the following actions:

    • If the Scope is Full Lot and Production Quantity is blank, TraceLink updates the status of all serial numbers in the lot to Market Released.
    • If the Scope is Full Lot and Production Quantity is included, TraceLink begins to asynchronously update the status of all serial numbers in the lot to Market Released. The processing status of the market release is available in Info Exchange.
  1. Hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update Functions drop-down, and then select Set Market Release Status.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code field.
  5. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers to be released.
  6. Enter the 14-character Russia Account Number of the Location performing the market release, as entered in Product Master Data.
  7. Select Partial Lot from the Scope radio buttons to indicate that only a portion of the lot's serial numbers are being released into Russia.
  8. Enter the released Serial Numbers 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.
  9. Specify the conformity documents for the product:
    1. Specify a State Confirmation document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select State Confirmation Number as the Identifier Type.
      3. Enter the Identifier Value of the State Confirmation document.
      4. Enter the Document Date printed on the State Confirmation document (optional if a Document Date is specified for a Civil Circulation document).
    2. Specify a Civil Circulation document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select Civil Circulation Release Number as the Identifier Type.
      3. Enter the Identifier Value of the Civil Circulation document.
      4. Enter the Document Date printed on the Civil Circulation document (optional if a Document Date is specified for a State Confirmation document).
    3. Specify additional conformity documents (optional):
      1. Select Add Another in the Transaction IDs table header.

      2. Specify a quality inspection document from the Identifier Type drop-down, which is used to certify that the product conforms to Russian legal, safety, and quality requirements.

      3. Enter the Identifier Value of the quality inspection document.
      4. Enter the Document Date printed on the quality inspection document.
  10. Enter the quantity of serial numbers commissioned at each packaging level of the lot in the Production Quantity table (optional):

    If a product is involved in a Commissioning or Aggregation event that is currently processing, TraceLink parks and retries the operation to verify the Production Quantity details for a given Lot Number before triggering any configured compliance reports.

    1. Identify items at the Each level:
      1. Select Add Level.
      2. Select the Each's GTIN, NTIN, or CN-Subtype identifier of the serial numbers assigned to the product's packaging level from the Packaging Code down-drop, as entered in Product Master Data.
      3. Enter the amount of serial numbers expected in the Packaging Level in the Quantity field.
    2. Identify items at another Packaging Level (optional):
      1. Select Add Level.
      2. Select a Packaging Level:
        • Each – The smallest salable unit a product can be serialized in.
        • Inner Pack/Bundle – Contains a group of eaches.

        • Case/Shipper – The next level of packaging. Contains a group of Inner Packs/Bundles.

          • SSCC – Enabled when Case/Shipper is selected.

            • If SSCC is selected, enter a GS1 Company Prefix in the Packaging Code field.
            • If SSCC is not selected, enter a GTIN, NTIN, or CN-ResCode in the Packaging Code field.
        • Pallet – The largest packaging level. Contains a group of Cases/Shippers.
      3. Select a Packaging Code.
      4. Enter the Quantity.
  11. Select Submit.

    The screen refreshes, and TraceLink takes one of the following actions:

    • If the Scope is Partial Lot and Production Quantity is blank, TraceLink updates the status of the specified serial numbers to Market Released.
    • If the Scope is Partial Lot and Production Quantity is included, TraceLink begins to asynchronously update the status of the specified serial numbers to Market Released. The processing status of the market release is available in Info Exchange.

Compliance report details

  • Report Date – The date and time that the report generated.
  • Report ID – The report's MDLP document ID.
  • Report Type – 342 - Release in Circulation.
Field Description Sourced From MDLP Report Element
Manufacturer ID The 14-character Russia Account Number of the location that completed the market release. Location in the market release. subject_id
Manufacturer Name The name of the location that completed the market release. Company Master Data, the name associated with the Location. Not reported
Packaging Code The GTIN associated with the serialized items. The serial numbers in the market release. Not reported
Description Description of the product. Product Master Data, the description associated with the Packaging Code. Not reported
Market Release Date The date that the market release is completed (i.e. the items are released for circulation). The date of the market release event. operation_date
Confirmation Number The value on the State Confirmation transaction document included with the market release. Identifier Value of the State Confirmation Transaction ID in the market release. confirmation_num
Document Number The value on the Civil Circulation transaction document included with the market release. Identifier Value of the Civil Circulation Transaction ID in the market release. doc_num
Document Date The date associated with the State Confirmation or Civil Circulation transaction document.

Document Date associated with the State Confirmation or Civil CirculationTransaction ID in the product release.

If both documents include a date, displays the date associated with the State Confirmation document.

 doc_date
  • Response Received – The date and time that TraceLink received a response message from MDLP.
  • Response Type – The response code from MDLP.
  • Status – The status of the report with MDLP.
  • Error Code – The error code returned by MDLP, if applicable.
  • Error Description – The description of the associated Error Code.