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MOVILITAS COMPANY

OVERVIEW
• Founded in 2006
• Headquarter in Mannheim (Germany)
• 15 offices across 3 continents (NA, Europe, Asia)

• Specialized Global SAP consulting company in Supply


Chain, Manufacturing, Track & Trace & Mobility Solutions

• Approx 250 employees globally (70 of them in WE


TRACK)

• Domain-level experts with deep solution and industry


experience

Digital Manufacturing
• Collaborative partner with SAP:
Since 2000
• SAP Software Solution and Technology Partner
Track & Trace
• SAP Services Partner
Since 2006
• SAP Consulting Partner
Mobile Solutions Cloud Solutions
• SAP User Since 2016
Since 2006
Warehouse Logistics
THE MOST SPECIALIZED PARTNER
FOR T&T AND THE MOST
COMPLETE T&T OFFERING
Movilitas Summary of Services Movilitas Areas of Services
▪ Stakeholder Management (Solutions Portfolio)
▪ Program Management
▪ SAP Track & Trace (ATTP, AII/OER, GTT)
▪ Project Management
▪ Requirements Gathering ▪ SAP GBT
▪ Blueprinting and Design ▪ Movilitas.Cloud and Mobile for T&T
▪ Implementation and Development ▪ Resourcing for T&T Experts
▪ Testing and Go-Live support
▪ Supply Chain Integrity
▪ Change management
▪ Training delivery
▪ Ongoing Support for operation of the
systems
▪ Support in QA/Validation
Movilitas
T&T Key Facts

▪ Movilitas has delivered (or is currently delivering) 65+ Serialization and Track & Trace projects since 2007

▪ Furthermore Movilitas has integrated it’s Track & Trace solutions (e.g. Movilitas.Cloud, SAP ATTP) system with various different partners.

▪ Movilitas has a broad range of SAP based as well as own developed solutions

▪ Movilitas is able to demonstrate today(!) full end to end serialization across all levels incl reporting functionality

▪ Movilitas has approx. 60 SAP Serialization and Track & Trace Solution consultants doing only and exclusively Serialization and Track &
Trace projects.

▪ This quantity and quality of expertise and resources is globally unique (even large integrators contract us!)

▪ Movilitas is doing Track & Trace projects


o in multiple industries (Pharma, Agro/Chemical, Food, Tobacco, Explosives)
o with different Supply Chain Partners (Manufacturers, CMOs, 3PLs, Wholesalers, Retailers)
Track & Trace
o across various continents (Europe, US, Asia) Since 2006
Pharmaceutical Serialization Requirements in Russia

The introduction of wide ranging serialisation regulation by the Russian authorities will
pose significant challenges to all pharmaceutical companies who supply product to the
Russian Federation.

In this webinar we will be focusing on enterprise systems and we will discuss:


▪ the key aspects of the regulation,
▪ the implications of the requirements and their potential impact,
▪ the critical commercial and architectural considerations that will need to be taken
into account in determining your implementation strategy.
Pharmaceutical Serialization Requirements in Russia

The Regulation
A quick look
Pharmaceutical Serialization Requirements in Russia
The Regulatory framework

The relevant decrees have all been passed by the Russian Parliament.

December: Federal law 61-03 (amended 425-03), introduces obligatory use of Data Matrices from 1/1/20

Order 2828 Dec 18th 2018, confirms CRPT as the permanent operator of the state MDLP reporting system

Decree 1556, Dec 14th 2018, defines the information to be included in the Datamatrix as well as defining the
basic reporting principles and requirements

There are some other related decrees, 1557, related to specific drugs (nosologies)
Pharmaceutical Serialization Requirements in Russia
The Timeline
The timelines are set and known
….. And highly aggressive

High Cost Nosology Dates Pharmaceutical Drugs

8/7/2019: MDLP registration 1/11/2019: MDLP registration

1/9/2019: MFG equipped 1/12/2019: MFGs equipped

1/10/2019: MFG equipped 1/1/2020: Commencement


Pharmaceutical Serialization Requirements in Russia
Introduction

The proposals cover: Reporting of detailed logistics movements


through the supply chain, including all changes
Labelling, to the packing hierarchies, to the Russian
authorities, the MDLP platform
Typical “new market” art work, labelling
Movement tracking includes the movement of
product through customs clearance
However …
We see some challenges relating to the 2D
The level of detail of the reporting is
data matrix, which has to contain GTIN, serial
significant
number….

And presents challenges…


and 2 cryptographic codes provided by the
Russian authorities
Pharmaceutical Serialization Requirements in Russia
Introduction

In the manufacturing space: In the logistics space:


Manufacturers provide their own serial
numbers, they are not provided by the Reporting begins from the moment a batch
Russian authorities. is prepared and is ready to be dispatched
to the customs warehouse, until such time
In addition to GTIN and serial numbers, the as the product is sold and moved to a
packaging lines need to be provided with distributor. Movements include tracking
additional information, cryptographic through customs clearance.
codes, which are provided by the Russian
authorities. This information must be
encoded into the data matrix (GTIN, serial,
Charging for codes has still
crypto-codes).
not been confirmed
Pharmaceutical Serialization Requirements in Russia
Introduction

Coding/labelling

The following data must be mandatorily encoded into the matrix:


• GTIN (app id 01)
• Serial number (app id 21)
• Key Id (app id 91)
• Signature (app id 92)
And optionally the following can be encoded into the data matrix:
• Batch (app id 10)
• Expiry Date (app id 17)
Not yet aware of
The crypto signature is (potentially) 88 chars, which places severe pressure on printany formal
quality andchange
speed
and as a consequence, there is an active debate going on with CRPT, who have suggested to the they
length
may
be willing to reduce it to 20 chars
Pharmaceutical Serialization Requirements in Russia

Impacts
Implications
Pharmaceutical Serialization Requirements in Russia
Implications

The Russian model is a full track and trace model; it is comprehensive and affects labelling, bar coding and
introduces serialization, aggregation and reporting requirements, including a unique concept; that of
applying a cryptographic signature to each GTIN/serial number combination. The impacts are therefore
pervasive:
▪ The packaging lines are impacted,
▪ The regulatory reporting requirements are extensive with potentially significant cost ramifications on
logistics operations,
▪ Due to the crypto-graphic requirement, there are key architectural design decisions to be made in the
manufacturing space, affecting the packaging lines and level 4 systems, especially for companies with
established serialisation systems for existing markets,
▪ CMO operations are impacted, again with potentially significant cost implications.

Due to the impacts on the manufacturing processes as well as the logistics processes anyone supplying
to the Russian market needs to put in place quickly a number of concurrent analysis activities directed to
provide appropriate stakeholders with the information they need to make informed decisions
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

The Manufacturing processes are impacted in two main ways:


1. the labelling/coding requirements, artwork, printing – these are normal impacts for a new
market
2. But the crypto-code requirement has significant and wide ranging impacts:
▪ Upon the lines and the line suppliers,
▪ Potentially on the level 4 systems interacting with the lines,
▪ Potentially on enterprise security,
▪ Potentially on enterprise middleware

The impact is pervasive


So let’s look briefly at the
labelling/encoding issue
Pharmaceutical Serialization Requirements in Russia
Introduction
So let’s recap
Coding/labelling

The following data must be mandatorily encoded into the matrix:


• GTIN (app id 01)
• Serial number (app id 21)
• Key Id (app id 91)
• Signature (app id 92)
And optionally the following can be encoded into the data matrix:
• Batchto(app
Due the id 10)
additional information, 92 chars of crypto related data, the data matrix size increases by about 40%
• Expiryassessment)
(GS1 Date (app idand
17) that pushes the resultant dot size below the threshold of most existing serialisation
equipment, and that raises a lot of potential issues at the line level , hence the current debate.
The crypto signature is (potentially) 88 chars, which places severe pressure on print quality and speed
All MaHs
and need to be working
as a consequence, thereclosely
is an with their
active line partners,
debate going onCRPT
withisCRPT,
activelywho
working
havewith supplier groups
suggested and
they may
over
be the next
willing few weeks,
to reduce keychars
it to 20 decisions and announcements are expected.
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

That’s one problem – but ACQUIRING the cryptos introduces new issues

So let’s have a look at the basics and what the implications of obtaining the cryptos might
be

And lets not forget that there may be a charge for the cryptos (as yet unspecified)

So what is this “crypto thing” anyway?


Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

Crypto-graphic protection of the data What does this mean?


matrix bar code (digital signing of each 1. It means that each and every serial
specific data matrix) number receives its own unique
specific digital signature.

Send request: GTIN+Serial number 2. You send the combination of GTIN +


Crypto serial number to the Russian crypto-
server graphic service and receive back GTIN
+ serial number + 2 fields, one of 4
Receive response: GTIN+Serial number + AI (91) 4 chars + AI characters and one of 88 characters
(92) 88 chars
(the digital signature).

3. These two fields must be encoded into


the Data Matrix printed on the pack.
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

Accessible from L4 or L3
Crypto-graphic protection of the data
matrix bar code (digital signing of each
The “gateway API” is accessible from a level 3 or 4 system, from
specific data matrix) a custom built middleware if necessary (or indeed from a L5)

When being accessed from outside the Russian federation the


Cloud based
Crypto server
requests are directed to the crypto-service.

Accessing from within the Russian Federation access goes via a


local hardware server (which can also act as a store for crypto-
Level 3 or 4 codes)

Gateway Hardware
API crypto server
Decision Point: L3 or L4 access to crypto-service
(Or L5)
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

Accessible from L4 or L3
Crypto-graphic protection of the data
matrix bar code (digital signing of each
specific data matrix)
Level 4 access to crypto service
Level 4 system requests the cryptos from the service, must
Cloud based
store and manage the crypto-serial pairs, distribute them to the
Crypto server lines as required (thus the line interfaces must change) and
report consumption to the crypto-service

Level 3 access to the crypto service


Level 3 or 4 Similarly Level 3 system requests the cryptos from the service,
consumes them on the line and must report the consumption.
Gateway Hardware
API crypto server
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

Accessible from L4 or L3
Crypto-graphic protection of the data
matrix bar code (digital signing of each
If you have multiple line suppliers and multiple lines affected,
specific data matrix) then the level 4 system will be the logical system to request and
store the crypto-codes, and then hand them down to the level 3
systems with the serial numbers
Cloud based
Crypto server
If you can localise the lines and sites impacted, then there is a
serious case to use an L3 solution, BUT the necessity for
involving enterprise security to access external Russian services
from automation networks is something most Line suppliers will
Level 3 or 4 not have experienced before. Access to external entities will be
assessed and managed by the enterprise teams.
Gateway Hardware
API crypto server
Software version management will come into play as well. If
you have lines from supplier A which supply to Russia and lines
from Supplier A which don’t, either you have two interface
versions or you have significant regression testing
Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

Accessible from L4 or L3

ATTP If you an SAP user and are using ATTP, then your only credible
option is to take the SAP FP for Russia, any custom
Lines development would be far too extensive and expensive, and far
too risky.
Russian specific serialisation implementation
[I do not believe there is an SAP option for OER/AII users]

Depending on numbers of lines impacted, site production


planning, line distributions, the necessity of regression testing
may be very significant and suggests that a dedicated Russian
“ATTP” be assessed as an option, whether for short term only
ATTP ECC or even as a permanent approach.
Lines

Existing serialisation services


Pharmaceutical Serialization Requirements in Russia
Implications - Manufacturing

Accessible from L5

SAP will be offering access to the crypto-service API via ICH as


well as ATTP

ICH Use of ICH , whether to access the crypto-services gateway API


Cloud based or simply to “Intermediate” between ATTP and the crypto-
Crypto server
services and MDLP platform should be actively considered as
part of any security evaluation, there are major advantages:
1. Assists onboarding and registration
2. Message filtering and boundary controls
Level 3 or 4
3. Reduced threat, better security

Gateway API Hardware


crypto server
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs

CMOs

And …

We need to consider the CMO impacts


Pharmaceutical Serialization Requirements in Russia
Implications - CMOs

MaHs and CMOs


1. The MaH may or may not generate the serial numbers, but the MaH is responsible for
the (non 311) MDLP reporting

2. The MaH may acquire the crypto-codes, distribute them to the CMO, and report
consumption (311)

3. The CMO may acquire the crypto-codes and report crypto consumption (311)

Depending on location
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs

MaH acquires and distributes the serial-crypto


combinations to the CMOs, receives back serial-crypto EU/RoW EU/RoW
confirmations
CMO MaH
MaH advises via 311 of crypto consumption

MaH reports to MDLP on commissioning or shipping

Interfaces between MaHs and CMOs changed

Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs

MaH acquires and distributes the serial-crypto


combinations to the CMOs, receives back serial-crypto EU/RoW Russia
confirmations
CMO MaH
MaH advises via 311 of crypto consumption

MaH reports to MDLP on commissioning or shipping

Interfaces between MaHs and CMOs changed

Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs

CMO acquires crypto codes, and reports consumption via


311 (CMO or MaH may generate the serials – but MaH is Russia EU/RoW
still responsible for MDLP logistics reporting, i.e. CMO
only reports the 311)
CMO MaH
Serial and commissioning details sent to MaH

Interfaces between MaHs and CMOs changed

Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - CMOs

CMO acquires crypto codes, and reports consumption via


311 (CMO or MaH may generate the serials – but MaH is Russia Russia
still responsible for MDLP logistics reporting, i.e. CMO
only reports the 311)
CMO MaH
Serial and commissioning details sent to MaH

Interfaces between MaHs and CMOs changed

Crypto-service MDLP
Pharmaceutical Serialization Requirements in Russia
Implications - Logistics

Then we get to the logistics aspects

What needs to be reported, when and who by?

What is the impact on warehousing operations?


Pharmaceutical Serialization Requirements in Russia
Implications - Logistics
Reporting to the MDLP is extensive
• requires information that is not necessarily (currently) available in ATTP or ECC,
• not every reporting event can be triggered from an EPCIS event
• All warehouse movements are reported
• Includes dependencies on customs movements

MDLP

Manufacturer Supplier Customs Warehouse Distributor


Bonded
warehouse
Pharmaceutical Serialization Requirements in Russia
Implications - Logistics
Crypto-service

MDLP
311 321 915 331 415 416
332 312 335 341
Usage Foreign Multi Foreign Move receive
Foreign Control FTS data receive
confirmation emission pack shipment order order
import samples importer

Manufacturer Supplier Customs Warehouse Distributor


Bonded
warehouse
Pharmaceutical Serialization Requirements in Russia
Implications - Logistics

MDLP Reporting - warehousing


MDLP

552 431 541/2 811 250 551 251/605 252/606 911 912 913 914 915 441 210
withdrawal Move place destruction relabelling recall Re-export Refusal Refusal Unit Unit Unit Unit Multi Move Query
sender receiver pack unpack extract append pack Unregistered SGTIN info
order
▪ All movements to the packaging hierarchies have to reported – this
means all typical serialised scanning operations (pack, unpack, sampling, Typical serialized scanning
destructions, etc

▪ If the warehouse handling the goods is a non-SAP warehouse then the


key decision is WHAT is the single source of truth for the hierarchy? Is it
ATTP? Is it the warehouse system? Which do you trust? Who is doing the
reporting to the MDLP?
Pharmaceutical Serialization Requirements in Russia
Implications - Logistics

MDLP Reporting - warehousing


MDLP

552 431 541/2 811 250 551 251/605 252/606 911 912 913 914 915 441 210
withdrawal Move place destruction relabelling recall Re-export Refusal Refusal Unit Unit Unit Unit Multi Move Query
sender receiver pack unpack extract append pack Unregistered SGTIN info
order

Typical serialized scanning


Decision Points:
What system(s) will be reporting to the MDLP?
▪ How many warehouse operators are involved?
▪ How will reconciliation occur?
Pharmaceutical Serialization Requirements in Russia
Implications - Logistics

MDLP Reporting - warehousing


MDLP

552 431 541/2 811 250 551 251/605 252/606 911 912 913 914 915 441 210
withdrawal Move place destruction relabelling recall Re-export Refusal Refusal Unit Unit Unit Unit Multi Move Query
sender receiver pack unpack extract append pack Unregistered SGTIN info
order

ATTP FP4 provides the reporting framework


1. Which makes it a very strong candidate to act as the reporting system
2. It also provides the means to acquire, manage and distribute the serial/crypto pairs, including
the 331 consumption confirmation
Pharmaceutical Serialization Requirements in Russia
Implications and Impacts

To summarise
impact impact
middleware impact
impact
Lines Level 4 Warehousing
ATTP or similar

impact
MDLP
Line systems
ERPs

impact
CMOs impact
Pharmaceutical Serialization Requirements in Russia

Critical
Considerations
Pharmaceutical Serialization Requirements in Russia
Critical considerations

… at programme initiation

1) There are a number of working groups that need to be set up to carry out the
necessary evaluations, make recommendations, assess impacts and risks
2) These evaluations need to be initiated quickly and in parallel, there are significant
decisions needed quickly and there are very considerable cost implications
3) These must feed into the programme steering or governance and result in
recommendations being submitted to the business stakeholders
Pharmaceutical Serialization Requirements in Russia
Critical considerations

Architectural working group

Architectural & design considerations


MFG/Packaging line CMO operations working Outsourcing and
Logistics working group
working group group partnerships

Costs, benefits analyses, risk considerations

PMO
Costs, risks, change, etc
Pharmaceutical Serialization Requirements in Russia
Critical considerations

Architectural working group

Needs to provide clear set of recommendations across entire serialisation environment, options considered, options
discounted, design risks, impacts on all affected systems summarised, strategy

1) Crypto-service gateway (L3 or L4) OR L5


2) Timelines for development/upgrades,
3) Impact on line interfaces
4) Impact on CMO interfaces
5) Reporting strategy (from ATTP or local partner for example)
6) SAP strategy - availability of the SAP feature pack (mid 2019)
7) Security considerations; security teams need to be involved to assess the appetite for security risk in accessing the
Russian crypto-service and reporting –
8) Assess and consider the use of SAP ICH to “sit” between customer and crypto-services and MDLP
Pharmaceutical Serialization Requirements in Russia
Critical considerations

Working group needed to assess impacts on printing, and in particular whether the data
matrices can be printed/read to appropriate quality standards. MaHs will need full
impact cost assessments from suppliers as well as clear timelines for implementation.

1) More than 1 line supplier affected? then rationalisation of interfaces to a single


standard is needed,
2) Do you end up with different interfaces to line suppliers depending on whether or
not they supply to the Russian market?
3) Or is it possible to localise the changes to specific lines and line suppliers?
MFG/Packaging line working group 4) Affects how much regression testing will be needed for lines not producing for
Russia
5) What are the impacts on site production (including sites not involved in Russia)?
6) Potential impact on production flexibility and planning
7) Are there are hardware impacts due to the print quality, speeds?
8) What’s the lead time to upgrade the lines?
Pharmaceutical Serialization Requirements in Russia
Critical considerations

L3 crypto-service gateway is a realistic option if


Your line supplier is able to support the interface in a timely fashion and that a very low
number of line suppliers are affected (1?).

Working assumption here is that you need to treat the line solution as a “black box”,
solely responsible for acquiring and managing the serial/crypto pairs, and that this black
box can meet the crypto/serial reporting (311) consumption confirmation.

MFG/Packaging line working group Regression and deployment remains an issue


CMO usage feeds into the decision

[BUT there remains the question of what do you do if you need to reprint the labels in
the warehouse? How does the warehousing system obtain new serials and associate
cryptos? Is it licensed to do so? Or do you simply “write off” in the warehouse?]

But if you can keep it simple and localise impact to one line supplier, minimal number
of sites, then L3 solution could be the cheapest initial solution. But only “IF”
Pharmaceutical Serialization Requirements in Russia
Critical considerations

MDLP reporting and Warehousing does NOT scale well for Russia

What do we mean by that?

The more warehouses involved in receiving , shipping and distributing product for Russia, the more complex it becomes, its more of a “J”
curve than a simple linear increase of complexity.

At the simple end of the spectrum: if for example you have 1 warehouse in Russia and 1 warehouse operator – it can be relatively simple,
get the Russian warehouse operator to do the MDLP reporting

At the complex end of the spectrum: if you have multiple warehouses all shipping to Russia, and they have significant warehouse
movements between batch release and shipping, with complex shipping routes and you have external warehouse operators in Russia –
reporting and reconciliation, maintaining integrity across multiple warehouses, the reporting system and the MDLP escalates into being
potentially hugely complicated

The more you can simplify and reduce the number of involved logistics nodes, especially logistics nodes that impact hierarchies, the
easier and cheaper it will be
Pharmaceutical Serialization Requirements in Russia
Critical considerations

Thus assessing the impact on warehousing is non trivial

Some of the considerations include:


1. Which system or systems will be the source of reporting to the MDLP? Level 4?
Outsourcing partner?
2. What warehousing systems are being used by the customs bonded warehouse partners in
Russia?
3. How will warehouse movements be captured and sent to the system responsible for MDLP
reporting?
4. How will the involved warehouses and the MDLP reporting be aligned and reconciled?
Logistics working group
5. Warehousing and shipping processes need to be reviewed in detail to identify the trigger
points for reporting, and the potential reconciliation points

Alignment of stock and hierarchies

Source shipping warehouse Customs bonded warehouse Russia Distribution warehouse Russia
Pharmaceutical Serialization Requirements in Russia
Critical considerations

MaH EEC data sources

MDLP reporting source


Flow of movement tracking

Local / outsourced operator

MaH Source shipping warehouse Customs bonded warehouse Russia Distribution warehouse Russia
Pharmaceutical Serialization Requirements in Russia
Critical considerations

MaH EEC data sources

MDLP reporting source


Flow of movement tracking
Local/outsourced operator

Source shipping warehouse Customs bonded warehouse Russia Distribution warehouse Russia
Pharmaceutical Serialization Requirements in Russia
Critical Considerations

1. MaH is responsible for MDLP reporting, CMOs may request the crypto-
codes on behalf of the MaH and report the commissioning (via 311)
2. Clear definition of responsibilities for CMOs defined and agreed
3. Data, interface and reporting specified and agreed
4. Reporting obligations a matter of contractual necessity
5. Existing and potentially new commercial and production strategies
should be assessed and the reporting requirements around crypto-
CMO working group confirmation agreed
6. Timelines and costs on options to be assessed and quantified
Pharmaceutical Serialization Requirements in Russia
Critical Considerations

A quick word on Outsourcing


Given the potential complexities of operating in the Russian market,
identifying the right Russian based partner(s) could be a critical and necessary
consideration

Outsourcing and A key decision is “what system” is going to be responsible for the MDLP
partnerships reporting? Which “node” in the logistics chain is the “cheapest”, i.e. reporting
from “where” has the least impact?

For organisations with complex logistics set-ups, using Russian operators who
can offer MDLP reporting services, warehousing services may be a serious
consideration, exchanging capital development costs for recurring annual
operational costs may be an expedient option, either initially or longer term.
Pharmaceutical Serialization Requirements in Russia
Critical Considerations

SAP considerations
Connectivity Options planned for mid 2019
▪ Direct Connection
o ATTP* provides the capabilities to generate most of the required messages for
file exchange. Events will be stored on a customer file share to be uploaded
manually to RU Government system with FP2
o Connection is planned with ATTP 2.4
▪ Gateway Connection
o SAP plans the gateway option to connect to the RU Government system
depending on the specific requirements in Russia – similar to EU
Boundary Conditions
▪ Both options require the RU Country Pack for ATTP.
▪ ATTP provides readily formatted messages through the RU country package. ICH does
not perform mapping for regulatory reporting messages.

▪ 1.SAP is in alignment with customers for deeper process integration into ERP processes and documents.
▪ 2. SAP to release soon updated interface specification for russian exchange scenarios: SNRequest/Response and Business
Partner connection.
Pharmaceutical Serialization Requirements in Russia
Critical Considerations

Conclusions
For all but the simplest serialisation setups, supplying the Russian market presents very significant
challenges:
▪ Impact on lines
▪ Impact on manufacturing processes and systems
▪ Impact on logistics processes and systems
▪ Impact upon partners

The key to keeping costs to acceptable levels is to simplify as much as possible.


▪ Minimize regression testing costs, thus localise impact if possible
▪ Identify the best and most effective place to carry out the MDLP reporting from
▪ Identify the best option for acquiring and managing the serial-crypto combinations
▪ Understand the flow of data that is required between the various nodes of the logistics chain
▪ Don’t over-reach – consider intermediate solutions, consider a dedicated Russian setup
Pharmaceutical Serialization Requirements in Russia
Critical Considerations

Questions
Pharmaceutical Serialization Requirements in Russia

Disclaimer
© 2019 Movilitas Consulting GmbH. All rights reserved.
No part of this publication may be reproduced or transmitted in any form or for any purpose without the permission of Movilitas Consulting
GmbH.

The information contained herein may be changed without prior notice.

These materials are provided by Movilitas Consulting GmbH for informational purposes, without representation or warranty of any kind, and
Movilitas Consulting GmBH shall not be liable for errors or omissions with respect to the materials.

In particular, Movilitas Consulting GmbH has no obligation to pursue any course of business outlined in this document or any related
presentation, or to develop or release any functionality mentioned therein. This document, or any related presentation, and Movilitas Consulting
GmbH’s strategy and possible future developments, products, and/ or platform directions and functionality are all subject to change and may be
changed by Movilitas Consulting at any time for any reason without notice. The information in this document is not a commitment, promise, or
legal obligation to deliver any material, code, or functionality. All forward-looking statements are subject to various risks and uncertainties that
could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking
statements, and they should not be relied upon in making purchasing decisions.

All products and service names mentioned are the trademarks of their respective companies.

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