You are on page 1of 16

IS-PHARMA REPORTING

Russian Federation

Abstract
IS-Pharma reporting notifications to meet statutory reporting requirements of the Russian
Federation

Avinash Ravipati
Table of Contents
331 – Foreign Shipment.....................................................................................................................2
333 – Custom Move...........................................................................................................................3
335 – FTS Data...................................................................................................................................3
552 – Withdrawal..............................................................................................................................4
542 – Destruction..............................................................................................................................5
541 – Move Destruction....................................................................................................................6
341 – Receive Importer.....................................................................................................................7
342 – Foreign Release........................................................................................................................7
415 – Move Order.............................................................................................................................9
701 – Accepting...............................................................................................................................10
911 – Pack........................................................................................................................................11
912 – Unpack...................................................................................................................................13
913 – Extract....................................................................................................................................14
914 – Append..................................................................................................................................15
915 – Multi Pack..............................................................................................................................16

1|Page
331 – Foreign Shipment
Import of medicinal drugs (MD) for medical use into the Russian federation from the countries that
are EEU (Eurasian Economic Union) non-members.

331 – Foreign Shipment


MAH/Representative Office Importer MDLP System

Need for MD
Need for MD shipment
importation to the
to the Russian federation
Russian federation

MD Shipment to the
Russian federation

Information transfer of 331 – Foreign Shipment Information registration


MD Shipment to the of MD Shipment to the
Russian federation Russian federation

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_331_SHIPMFR_FL,
/STTP/RU_CREATE_NTF configured for shipping
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_CONTRACT_TYPE - Sale Contract Type
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_CUST_RECV_ID - Custom Receiver ID
(or, registration type RU_CUSTRID maintained for BP from
destination, owning party GLN)
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

2|Page
333 – Custom Move
Transfer of medicinal drugs (MD) for medical use between the customs controlled areas by the
importer in Russian federation, imported from countries that are EEU (Eurasian Economic Union)
non-members.

334 – Custom Move


Importer MDLP System

Notification about
MD transfer between confirmation of MD
customs controlled areas importation to the
Russian federation

Information transfer of Information registration


334 – Custom Move
MD transfer between of MD transfer between
the customs controlled the customs controlled
areas areas

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_334_CUSTMV_FL,
/STTP/RU_CREATE_NTF configured for receiving
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_CUST_SHIP_ID - Custom Shipper ID
(or, registration type RU_CUSTSID maintained for BP from
source, owning party GLN)
RR_RU_CUST_RECV_ID - Custom Receiver ID
(or, registration type RU_CUSTRID maintained for BP from
destination, owning party GLN)
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

3|Page
335 – FTS Data
Customs clearance of medicinal drugs (MD) for medical use imported into the Russian federation
from the countries that are EEU (Eurasian Economic Union) non-members.

335 – FTS Data


Importer MDLP System

MD customs clearance

Information transfer of 335 – FTS Data Information registration


MD customs clearance of MD customs clearance
results results

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_335_FTSDATA_FL,
/STTP/RU_CREATE_NTF configured for entering_exiting
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_CONFIRM_DOC - Document Type of Conformity
Confirmation
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_CUSTOMS_CODE - Customs Code
RR_RU_CUSTOMS_VALUE - Cost value
RR_RU_REG_DATE - Registration Date
RR_RU_GTD_NUMBER - Goods Declaration Number
RR_RU_CUST_PRCD_CODE - Customs Procedure Code
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

4|Page
552 – Withdrawal
Withdrawal of medicinal drugs (MD) for medicinal use from circulation for a variety of reasons.

552 - Withdrawal
Pharmaceutical Entity MDLP System

Need for MD withdrawal


from circulation

MD withdrawal from
circulation for various
reasons

Information transfer of 552 - Withdrawal Information registration


MD withdrawal from of MD withdrawal from
circulation circulation

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_552_WITHDRL_FL,
/STTP/RU_CREATE_NTF configured for destroying
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_WITHDRWL_TYPE - Withdrawal Type
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

542 – Destruction
Destruction of defective, infringing and faulty medicinal drugs (MD) for medicinal use.

542 - Destruction
Company Performing
Pharmaceutical Entity MDLP System
Destruction

MD Destruction

Transfer of the act of MD Receiving act of MD


destruction destruction

542 - Destruction
Information transfer of Information registration
MD destruction of MD destruction

5|Page
Notification Trigger Manual Automated
Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_542_DESTR_FL,
/STTP/RU_CREATE_NTF configured for destroying
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_DESTR_METHOD - Destruction Method
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

541 – Move Destruction


Transfer of defective, infringing and faulty medicinal drugs (MD) for medicinal use, for destruction.

541 - Move Destruction


Company Performing
Pharmaceutical Entity MDLP System
Destruction

Need for MD Destruction

Transfer MD to MD acceptance for


destruction destruction

Information transfer of 541 - Move Destruction Information registration


MD transfer for of transfer MD for
destruction destruction

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_541_MOVDSTR_FL,
/STTP/RU_CREATE_NTF configured for destroying
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_DESTRUCT_TYPE - Reason for Transferring for
Destruction
RR_RU_DECISION - Destruction Decision
RR_RU_ACT_NUMBER - Destruction Act Number
RR_RU_ACT_DATE - Date DD.MM.YYYY
RR_RU_AOGUID – AO GUID
RR_RU_HOUSEGUID – House GUID
RR_RU_FLAT – Flat
Digital Signature Supported
Requires System/User configuration

6|Page
Enhancement Dashboard for digitally signing the triggered notification files

341 – Receive Importer


Receiving of medicinal drugs (MD) for medicinal use into warehouse by importer after clearance
from customs area when importing into the Russian federation.

341 – Receive Importer


Importer MDLP System

Need for MD acceptance


for importer͛s warehouse
and introduction into
circulation

MD shipment from the


customs controlled area

MD acceptance to the
warehouse

Information transfer of 341 – Receive Importer Information registration


MD acceptance to the of MD acceptance to the
warehouse Russian federation

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_341_RECIMP_FL,
/STTP/RU_CREATE_NTF configured for receiving
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_CUST_SHIP_ID - Custom Shipper ID
(or, registration type RU_CUSTSID maintained for BP from
source, owning party GLN)
RR_RU_COST_TAXES – Cost value
RR_RU_VAT_VALUE – Vat value
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

7|Page
342 – Foreign Release
Introducing medicinal drugs (MD) for medicinal use into circulation.

342 – Foreign Release


Importer MDLP System

Information transfer of
MD introducing into
circulation

342 – Foreign Release

Information registration
of MD introducing into
circulation

Notification Trigger Manual Automated


Not Supported Not Supported
Requires custom rule
development and
implementation
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_CONF_NUM – Confirmation Document Number
(Custom parameter to be configured)
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

8|Page
415 – Move Order
Shipment of medicinal drugs (MD) for medicinal use from shipper’s warehouse.

415 – Move Order


Shipper (Seller) MDLP System

Need for MD shipment


from shipper͛s
warehouse

Preparation of shipment

MD shipment from
shipper͛s warehouse

415 – Move Order Information registration


Information transfer of
of transfer of MD
MD shipment
shipment

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_415_MOVEORD_FL,
/STTP/RU_CREATE_NTF configured for receiving
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_DOC_NUM - Document Number
RR_RU_DOC_DATE - Document Date (DD.MM.YYYY)
RR_RU_TURNOVER_TYPE - Turnover Operation Type
RR_RU_SOURCE - Source of Financing
RR_RU_CONTRACT_TYPE - Sale Contract Type
RR_RU_CONTRACT_NUM - Contract Number
RR_RU_COST – Cost value
RR_RU_VAT_VALUE – Vat value
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

9|Page
701 – Accepting
Acceptance of medicinal drugs (MD) for medicinal use for various scenarios.

701 - Accept
Accepting Party MDLP System

MD Owner
Acceptance of MD by
Owner

Importer
Confirmation of MD
shipment
701 - Accept

MAH/Representative
Confirmation of MD
Import

New MD Owner Information registration


Confirmation of MD of transfer of MD
owner change shipment

Receiver (Buyer)
Confirmation of MD
shipment

Shipper (Seller) 701 - Accept


Confirmation of MD
acceptance

Receiver
Confirmation of return of
suspended MD

Notification Trigger Manual Automated


Supported Supported
SAP delivered standard SAP delivered standard rule
report. RR_RU_701_ACCEPT_FL,
/STTP/RU_CREATE_NTF configured for accepting
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
RR_RU_CONF_PAUSED - Paused Drugs Confirmation
Digital Signature Supported

10 | P a g e
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

911 – Pack
Aggregation of medicinal drugs (MD) for medicinal use package.

911 – Unit Pack


Pharmaceutical Entity MDLP System

Need for aggregation of MD


packages

Generation of individual
serial numbers of
tertiary (shipping)
packages
Information registration
Determination of of aggregation of tertiary
completeness and MD package
number of tertiary
(shipping) packages

Is there a set of
tertiary packages?
911 – Unit Pack
NO
MD packing in tertiary
(shipping) package

Information transfer of
aggregation of MD
package

Notification Trigger Manual Automated


Not Supported Supported
SAP delivered standard rule
RR_RU_PACK_FL, configured
for packing business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
NA
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

11 | P a g e
912 – Unpack
Deconsolidation (destruction) of tertiary MD package.

912 – Unit Unpack


Pharmaceutical Entity MDLP System

Need for deconsolidation of


tertiary MD package

Deconsolidation of
tertiary MD package

Information transfer of 912 – Unit Unpack Information registration


deconsolidation of of deconsolidation of
tertiary MD package tertiary MD package

Notification Trigger Manual Automated


Not Supported Supported
SAP delivered standard rule
RR_RU_UNPACK_FL,
configured for unpacking
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
NA
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

12 | P a g e
913 – Extract
Extraction of medicinal drugs (MD) for medicinal use packages from tertiary package.

913 – Unit Extract


Pharmaceutical Entity MDLP System

Need for extraction of MD


packages from tertiary
(shipping) package

Extraction of MD
packages from tertiary
(shipping) package

Information transfer of Information registration


913 – Unit Extract
extraction of MD of extraction of MD
packages from tertiary packages from tertiary
(shipping) package (shipping) package

Notification Trigger Manual Automated


Not Supported Supported
SAP delivered standard rule
RR_RU_UNPACK_FL,
configured for unpacking
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
NA
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

13 | P a g e
914 – Append
Extra inclusion of medicinal drugs (MD) for medicinal use packages into tertiary (shipping) package.

914 – Unit Append


Pharmaceutical Entity MDLP System

Need for extra inclusion of


MD packages into tertiary
(shipping) package

Extra inclusion of MD
packages into tertiary
(shipping) package

Information transfer of Information registration


914 – Unit Append
extra inclusion of MD of extra inclusion of MD
packages into tertiary packages into tertiary
(shipping) package (shipping) package

Notification Trigger Manual Automated


Not Supported Supported
SAP delivered standard rule
RR_RU_PACK_FL, configured
for packing business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
NA
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

14 | P a g e
915 – Multi Pack
Aggregation of sets of tertiary packages.

915 – Multi Pack


Pharmaceutical Entity MDLP System

Need for aggregation of MD


packages

Generation of individual
serial numbers of
tertiary (shipping)
packages
Information registration
Determination of of MD packing in set of
completeness and tertiary packages
number of tertiary
(shipping) packages

Is there a set of
tertiary packages?
915 – Multi Pack
YES
MD packing in set of
tertiary packages

Information transfer of
MD packing in set of
tertiary packages

Notification Trigger Manual Automated


Not Supported Supported
SAP delivered standard rule
RR_RU_915_MULTPCK_FL,
configured for packing
business step.
Data Required Additional Event Attributes (From EPCIS Inbound)
NA
Digital Signature Supported
Requires System/User configuration
Enhancement Dashboard for digitally signing the triggered notification files

15 | P a g e

You might also like