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Introduction into Circulation

Marketing Authorization Holders (MAHs) and Importers that own Russia Health Products Compliance can generate an Introduction into Circulation report to capture the circulation of Biologically Active Food Supplements (BAFS) and Medical products that are imported into Russia and approved by customs for distribution. The reports are submitted to the Track & Trace Government Information System (TT GIS).

Configure the report

The report for a product is generated when its product type is set to the corresponding product group in Product Master Data:

  • Product type as Food Supplement for BAFS

  • Product type as Medical Device for Medical Products

The event triggers (i.e. workflow subscriptions) for the report can be set in Administer for Russia Health Products Compliance. Make sure one of the following event triggers are enabled:

Source Application Event Action Description
Serialized Operations Manager Country Clearance Generate Introduction into Circulation Report from Core Integration TraceLink generates an Introduction into Circulation report for serialized items imported into Russia and approved by customs for distribution when the country clearance is submitted via core integration or the Web UI, as long as all of the event trigger conditions are met.
Serialized Operations Manager Country Clearance Generate Introduction into Circulation Report from ESM Integration TraceLink generates an Introduction into Circulation report for serialized items imported into Russia and approved by customs for distribution when the country clearance is submitted via ESM integration, as long as all of the event trigger conditions are met.

For more information on how to enable the event triggers, see the Administer Help Center.

Russia Health Products Compliance generates the Introduction into Circulation report when TraceLink processes a Country Clearance (XML), Country Clearance (EPCIS v1.2) or ESM Country Clearance event and the following conditions are met:

  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM (unit of measure) of Each.
  • In Product Master Data, the serialized item is associated with an Item Code that has a Target Market of Russia.
  • The Clearance Type is Customs.
  • The Import from Country is a country other than Russia, Armenia, Belarus, Kazakhstan, or Kyrgyzstan, and the Import to Country is Russia.
  • In Product Master Data, the Product Type of the serialized item is Food Supplement for Biologically Active Food Supplements or Medical Devices for Medical Products.

Generate the report

To generate the Introduction into Circulation report automatically, enable the appropriate event triggers and ensure that the relevant event trigger conditions are met in Master Data Exchange. When configured, Russia Health Products Compliance generates the Introduction into Circulation report automatically when Tracelink processes a Country Clearance or an ESM Country Clearance workflow event in one of the following interfaces:

Use any of the following Serialized Operations Manager APIs to trigger the Introduction into Circulation report:

Country Clearance (XML)

Complete the elements required for the report as follows. See the Serialized Operations Manager Core Integration API Guide for more information.

Element Values
cmn:ClearanceType

CUSTOMS

cmn:ImportToCountry RU (Russian Federation)
cmn:ImportingPartyId Specify the importing party identifier.
cmn:ImportFromCountry Specify the country the product is being imported from (must be a country other than Russia, Armenia, Belarus, Kazakhstan, or Kyrgyzstan).
cmn:CustomsAuthorityCode Specify the authority code of the customs agency performing the clearance.
cmn:DeclarationReleaseNumber Specify the customer declaration release number of the items approved for release by customs.
cmn:ActionCode Domestic
cmn:RegistrationDate Specify the customs registration date.

Country Clearance (EPCIS v1.2)

Complete the elements required for the report as follows. See the Serialized Operations Manager Core Integration API Guide for more information.

Element Values
tl:clearanceType

CUSTOMS

tl:importToCountry RU (Russian Federation)
tl:importingPartyId Specify the importing party identifier.
tl:importFromCountry Specify the country the product is being imported from (must be a country other than Russia, Armenia, Belarus, Kazakhstan, or Kyrgyzstan).
tl:customsAuthorityCode Specify the authority code of the customs agency performing the clearance.
tl:declarationReleaseNumber Specify the customer declaration release number of the items approved for release by customs.
tl:actionCode Domestic
tl:registrationDate Specify the customs registration date.

ESM Country Clearance

Complete the elements required for the message. See the Serialized Operations Manager Enterprise Serialization Management API Guide for more information.

Element Values
tl:clearanceType

CUSTOMS

tl:importToCountry RU (Russian Federation)
tl:importingPartyId Specify the importing party identifier.
tl:importFromCountry Specify the country the product is being imported from (must be a country other than Russia, Armenia, Belarus, Kazakhstan, or Kyrgyzstan).
tl:customsAuthorityCode Specify the authority code of the customs agency performing the clearance.
tl:declarationReleaseNumber Specify the customer declaration release number of the items approved for release by customs.
tl:actionCode Domestic
tl:registrationDate Specify the customs registration date.

Use Serialized Operations Manager to trigger the Introduction into Circulation report from the Web UI. See the Serialized Operations Manager Online Help for more information.

  1. In Track & Trace Services (TTS), hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Inbound Movement drop-down and then select Declare Country Clearance.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Complete the fields required for the report as follows:
    FieldValues
    Clearance TypeCustoms Clearance
    Importing to CountryRU (Russian Federation)
    Importing PartyThe importing party identifier.
    Importing From CountryThe country the product is being imported from (must be a country other than Russia, Armenia, Belarus, Kazakhstan, or Kyrgyzstan).
    Customs Authority CodeThe authority code of the customs agency performing the clearance.
    Customs Declaration Release NumberThe customer declaration release number of the items approved for release by customs.
    Customs ActionIssue for Domestic Consumption
    Registration DateThe customs registration date.
    Customs Authority CodeSpecify the Customs Authority Code of the customs agency performing the clearance if duplicates are found for Customs Declaration Release Number and Registration Date combination.

  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.

  6. Select Submit.

    A confirmation dialog box displays.

  7. Select Confirm.

    The dialog box closes and the country clearance information is submitted.

To generate the Introduction into Circulation report manually, use the Russia Health Products Compliance Web UI. This option is useful if a report failed to generate automatically, and the information must still be submitted to the Track & Trace Government Information System (TT GIS).

  1. Select the Main Menu icon .
  2. Select Russia Health Products Compliance.

    A new tab opens and displays information for the Russia Health Products Compliance app.

  3. Select the Generate Report icon.
  4. Select Introduction into Circulation as the Report Type to generate.
  5. Fill in the following fields:
    • Report Type drop-down – Required. Select Introduction into Circulation as the Report Type.
    • Customer Declaration Release Number field – Required. The customer declaration release number of the items approved for release by customs.
    • Registration Date field – Required. The customs registration date.
    • Custom Authority Code field – Required. The authority code of the customs agency performing the clearance.

  6. Select Generate.

    The panel closes, and TraceLink begins generating the report. Filter to find the new report.

Report details

Field Description Sourced From TT GIS Report Element
Report Type Displays as Introduction into Circulation. The type of report. Not reported
Status

The status of the report:

  • Generated – The report is generated in TraceLink but not yet submitted to the TT GIS.
  • Generation Failed – The report failed to generate in TraceLink.
  • Submitted – The report is generated and successfully submitted to the TT GIS.
  • Submission Failed – The report is generated but was not successfully submitted to the TT GIS.
  • Failed – The TT GIS received the report successfully but failed to provide a response.
  • Accepted – The TT GIS received the report successfully and accepted the information.
  • Partially Accepted – The event has multiple reports, and all of them are successfully submitted to the TT GIS, but the TT GIS did not accept all of the reports.
  • Rejected – The TT GIS received the report successfully but rejected the information.

The status of the report.

Not reported
Participant INN The Tax Identification Number (INN). Tax identification number of the reporter. trade_participant_inn
Product Group

The product group:

  • Biologically Active Food Supplements

  • Medical Products

The product group. Not reported
Event Type

The event type:

  • Country Clearance
  • ESM Country Clearance
  • Country Clearance XML
The type of event. Not reported
Date Reported The date and time that the report is generated. The system date and time when the report is generated. Not reported
Field Description Sourced From TT GIS Report Element
Importing Party Name The name of the company or location that completed the country clearance declaration. The name of the company or location associated with the Importing Party in the Country Clearance event.

Not reported
Importing To Country The country that the product is shipped into. The value is Russia. The Importing To Country in the Country Clearance event.

Not reported
Importing From Country The country that the product is shipped out of. The Importing From Country in the Country Clearance event.

Not reported
Declaration Date The date that the shipment is registered with customs.

The customs Registration Date in the Country Clearance event.

 declaration_date

 
Declaration Number The declaration release number for the product. The Customs Declaration Release Number in the Country Clearance event. declaration_number

 
Field Description Sourced From TT GIS Report Element
Packaging Code The packaging code for the product. The Packaging Code of the serialized item in the shipment.

Not reported
Product Description The name of the product. The description associated with the Packaging Code in Product Master Data.

Not reported
Lot Number The lot number associated with the packaging code used to report the serial numbers. The lot number associated with the Packaging Code in Serialized Operations Manager for this product's serialized items.

Not reported

 
Manufacturing Date The manufacturing date for the serialized items. The manufacturing date associated with the Lot Number in Serialized Operations Manager for this product's serialized items. If the product manufacturing date does not exist in Product Master Data, the Commissioning Date is used for the report.

Not reported

 
Expiration Date The expiration date for the serialized items. The expiration date associated with the Expiration Date in Serialized Operations Manager for the serial numbers in this lot.

Not reported

 
Quantity The quantity of serial numbers for the Packaging Code and Lot Number. The quantity of serial numbers in the shipment for the Packaging Code and Lot Number.

Not reported

Tips

  • Select the Export icon to export the serial numbers for a Packaging Code and Lot Number to a CSV file.

Response information when using the message status query service:

  • Report ID – The unique ID returned by the TT GIS for the submitted compliance report.
  • Report Name – The name of the compliance report submitted to the TT GIS.
  • Date Response Received – The date the response is received from the TT GIS.
  • Status – The status returned by the TT GIS for the submitted compliance report.
  • Status Code – The HTTPS code returned by the TT GIS for the submitted compliance report.
  • Description – The description returned by the TT GIS for the submitted compliance report.

Tips

  • Select the Action icon, and then select Export Report File to export the report file submitted to the TT GIS.
  • Select the Action icon, and then select Export Response File to export the response file received from the TT GIS.