Arvato CSDB Russian Pharma Track & Trace Package

1. General Information about Serialization in Russia

The Russian Federation is a pioneer in serialization. They have already launched

mandatory serialization for some product categories – for example: tobacco and furs.

Serialization supports market transparency, quality of the products and protection of

consumers from illegally produced goods.

The necessity to implement serialization applies to perfumes, cameras, lamps, tires,

coats, jackets, capes and milk. Some of them are already at pilot stage. However, the

most important pilot project is the serialization of medicaments.

Serialization of Medicaments will be mandatory from January 2020.

The System for Russian Serialization, called Monitoring Dvijenia Lekartsvennikh

Preparatov (MDLP), was developed by the Russian Technology Provider CRPT. Unlike

other countries‘ process serialization, the Russian system not only provides unique

identification codes to mark every box of medicaments, it will also track every

movement of them. This full Track & Trace approach makes aggregation a basic

necessity.

Because of the fact that the Governmental Degree about obligatory identification

code was implemented, it is very important that pharma producers are ready to print

the Russian Identification Codes (including the Crypto Code) on the packages of

medicaments that are distributed in the Russian market.

Business Solution

Russian Requirements in a Nutshell:

– Russian Track & Trace regulations

are postponed to 2020

– All medicines are effected incl.

over the counter (OTC) products

– A 2D code on every secondary pack

or bottle is required

– Serial number will be enriched by

a crypto code

– Aggregation is required due to

supply chain reports

– Up to 70 notification messages

are required to report

1

2

Multi-Flexible On-premise & Cloud Solution with the Benefits of:

– Privacy of your data in your data

center

– Flexible configurable for your

business process

– Connection with MDLP

– Exchange of production orders

with manufacturing companies

– Existing interfaces by line vendors

to Arvato CSDB core

– Supports multiple hardware solution

for logistic processes

2. Arvato Systems‘ Footprint in Serialization

Arvato Systems is one of the leading Serialization Software Solution providers having a very

long experience in this field. Arvato Systems offers with its Corporate Serialization Database

(Arvato CSDB) a solution which brings all the elements of serialization for pharma applications

together. The solution can be integrated into existing ERP systems, creating interfaces with

production lines, suppliers, production sites and verification systems. With this solution Arvato

Systems supports since 2011 the top 20 pharma companies as well as midsize and small

pharma companies to comply with local Track & Trace regulations in various countries all over

the world. Beside this, Arvato Systems is providing the National Verification Systems for 17

countries across Europe and connects them with the EU Hub.

3. Arvato CSDB Russian Pharma Track & Trace Package

The Arvato CSDB Russian Pharma Track & Trace Package covers scenarios like exporting to

Russia without a local representative or MAH Business in Russia as further detailed in the below

table:

Business Model Descrip�on

Relevant Processes

Prod. incl.

Crypto Code

Custom Clearance

Import Message

Shipping Message

Packaging Messages

Market Messages

European MAHwithout Russian Representa�ve office

• The foreign MAH has to be registered due to RussianLegisla�on

• The foreign MAH has to send import messages aboutemission of medicaments, shipping the medicaments

• Further work is being done by the Importer

X

Export to Russia with local representa�ve

• The foreign MAH has to be registered due to RussianLegisla�on

• The foreign MAH has to send export messages aboutemission of medicaments, shipping the medicaments toRepresenta�ve Office, which forwards them to MDLP

• Representa�ve Office is responsible for Descrip�on ofMedicament in MDLP

• In case if the Representa�ve office is authorized by Law itcan also act as an Importer or further on as a Wholesaler

X X X X X X

Wholesaler Russian Resident

• The Wholesaler transports Medicaments from CustomsWarehouse to Retail

• Every Medicament status change should be reported bythe Wholesaler, un�l He is the owner of the Medicament

X X X

RussianProducer

• Produces the Medicament, prints Cryptocodes• Puts it into circula�on via Wholesaler• He is responsible for all the messages un�l he is the Owner

of Medicament

X X X X

Import to Russia Business

• The Importer is responsible for Medicaments CustomCrossing Processes

• Import and shipping messages are being sent by ImporterX X X X

4. Solution Overview

To cover the various business models, Arvato Systems offers an IT solution

architecture which supports reporting, manufacturing and logistical processes. The

heart of the architecture is the Arvato CSDB product family, as further detailed in

the figure below:

Figure 1: The architecture of the Arvato CSDB Landscape.

All harmonized working components in the architecture supports a pharma

company within its business model. Depending on which business model and in

which combination a pharma company is acting on the Russian market Arvato

Systems can “Mix & Match” the different modules to a customer required specific

solution package. Each module is covering and supporting specific processes within

the supply chain.

3

Arvato Smart Logistics Platform - Healthcare Suite

– Mobile application fast & easy to

install on existing IT landscape &

mobile devices

– Business application monitors and

controls operational processes

– Process transparency in real time

Your contact to the Serialization Experts:

Arvato Systems | Serialization Experts An der Autobahn 200 | 33333 Gütersloh | GermanyTel.: +49 5241 80-75475 | E-mail: serialization@bertelsmann.de arvato-systems.com/serialization

Global IT specialist Arvato Systems supports major companies through digital transformation. More than 2,600 staff in over 25 locations epitomize in-depth technology expertise, industry knowledge and focus on customer requirements. Working as a team, we develop innovative IT solutions, transition our clients into the Cloud, integrate digital processes and take on IT systems operation and support.

In the healthcare segment, Arvato Systems covers the entire end-to-end process chain with its own serialization solutions. These solutions support both individual manufacturing companies and national verification systems. Arvato Systems has been selected as an official service provider by the European Medicines Verification Organisation (EMVO). We rely on our own team of serialization experts, which has already implemented numerous projects in the international environment.

As a part of the Bertelsmann-owned Arvato network, we have the unique capability to work across the entire value chain. Our business relationships are personal; we work with our clients as partners, so that together we can achieve long-term success.

© Arvato Systems GmbH, An der Autobahn 200, D-33333 Gütersloh4

5. Arvato Systems‘ Experts for being compliant with Track & Trace Regulation

As the Russian Track & Trace requirements are connected to multiple supply chain processes, Arvato Systems‘ experts are pleased to

support you on your process fitting compliance package, answering your questions or provide you with further information. Please

get in contact with us and we will draw you how our solution will look for your business model and IT landscape.

Product Features Descrip�on

CSDBSite Manager(Level 3)

Local Management of Produc�on & Packaging with Serializa�on and Aggrega�on incl. Approval-Mgmt.

Connectors to various Line Management solu�ons Reworking of Orders Aggrega�on and De-Aggrega�on of Orders Local Crypto Code Management

Independent system that supports flexibility in line provider selec�on

Automated interfaces without need of manual interac�on ensures secure processes

Line Independent Aggrega�on and De-Aggrega�on of Orders prevents from �me losses

CSDBCore(Level 4)

Ar�cle master Data Management incl. Russia Extension Management of Serialializa�on Processes on Enterprise

level Serial Number Genera�on and Management incl.

Provisioning ERP-Interface Interface Management of NMVS-Repor�ng-Processes Crypto Code Management (Wholesaler License) incl. L3

and/or external Manufacturer provision

Seamless integra�on with ERP for automated transac�ons without the need of manual interac�ons

Efficient Management of Produc�on Sites and Business partner Integra�ons

Compliance to Regula�ons and Markets

CSDBTrack & Trace Repository(Level 4)

Central Storage of EPC / serial number history Capturing of all Supply Chain Events Provisioning of informa�on to supply chain members and

business partners (push or pull) Storage of Regulatory transac�ons as EPCIS events (by

use of appropriate extensions)

As the only point of truth, it prevents from data inconsistencies.

Provides EPC live cycle transparency over the whole supply chain

Supports regulatory/market speciali�es Supports the integra�on with supply chain members e.g.

3PL´s

ASLP HealthcareSuite(Level 4/4)

Manages the Repor�ng to MDLP Flexible way of data input for message/report crea�on:

Manual Input, Scan, T&T Repository, Others Opera�onal Process Support Hybrid Solu�on with Cloud Based Control Center and

Business Applica�on for Mobile Devices

Fast adap�ons to possible regulatory changes within “experiment” phase

Degree of Integra�on can be increased over �me Support for opera�onal processes not yet supported by IT

systems (e.g. Customs clearing in the context of the new regula�ons)

CSDBGateway(Level 5)

Connector to the external world to manage serializa�on workflows enterprise wide and over company boundaries

Connec�on to na�onal verifica�on systems incl. Russian Markirovka

Connec�on to all business partners: MAHs, CMOs, Preprinters, Packaging/3 PL

Different ways of data exchange Hosted and managed by Arvato Systems

Profit from established network Simple and fast integra�on of NMVS and business partners Standard Connectors to the known solu�on providers

available Seamless and format independent connec�on of individual

Partners Stable Opera�ons