Professional Documents
Culture Documents
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.
Need for MD
Need for MD shipment
importation to the
to the Russian federation
Russian federation
MD Shipment to the
Russian federation
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.
Notification about
MD transfer between confirmation of MD
customs controlled areas importation to the
Russian federation
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.
MD customs clearance
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
MD withdrawal from
circulation for various
reasons
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
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
6|Page
Enhancement Dashboard for digitally signing the triggered notification files
MD acceptance to the
warehouse
7|Page
342 – Foreign Release
Introducing medicinal drugs (MD) for medicinal use into circulation.
Information transfer of
MD introducing into
circulation
Information registration
of MD introducing into
circulation
8|Page
415 – Move Order
Shipment of medicinal drugs (MD) for medicinal use from shipper’s warehouse.
Preparation of shipment
MD shipment from
shipper͛s warehouse
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
Receiver (Buyer)
Confirmation of MD
shipment
Receiver
Confirmation of return of
suspended MD
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.
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
11 | P a g e
912 – Unpack
Deconsolidation (destruction) of tertiary MD package.
Deconsolidation of
tertiary MD package
12 | P a g e
913 – Extract
Extraction of medicinal drugs (MD) for medicinal use packages from tertiary package.
Extraction of MD
packages from tertiary
(shipping) package
13 | P a g e
914 – Append
Extra inclusion of medicinal drugs (MD) for medicinal use packages into tertiary (shipping) package.
Extra inclusion of MD
packages into tertiary
(shipping) package
14 | P a g e
915 – Multi Pack
Aggregation of sets of tertiary 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
15 | P a g e