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SIGYN AGENS

EFFECTIVNESS OF ANY GIVEN SYSTEM IS

PROPORTIONAL TO THE LEVEL OF INSIGHT
MANAGER CAN ACHIVE TO ITS SMALLEST PART
CHARLES BROWN

SG-AG CORE
UNIQUE INTEGRATED SYSTEM FOR CONTROL AN REGULATION OF THE DRUG MARKET

INSURANCE OF AUTHENTICITY OF THE DRUGS ON THE MARKET

TRACEBILITY OF ALL PRODUCTS ON THE DRUG MARKET
DRUG REGISTER
PROCESS MANAGEMENT
PRICE REGULATION
ANALYSIS AND SIMULATION
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SIGYN AGENS

Sg-Ag CORE is a complete solution for the control and regulation of the drugs market and medical
products: control, monitoring, security authentication, ensuring traceability and drug market man-
agement as well as for conducting other procedures prescribed by the regulations and laws in a
systematic and easy way.

Software solution consists of a series of related program modules and methods that are integrated
into a unified system and provide a simple and systematic insight into all aspects of the drugs and
medical products market.

KEY BENEFITS
CONTROL OF PARTICIPANTS IN THE MARKET COMPETITION
Controling, monitoring and determening of the final price of medicines by tracking proposals
from manufacturer / authorization holder

SUCCESSFUL NEGOTIATION OF DRUG PRICES

Simple and quick verification of all data types will allow you a signinficant advantage in
negotiating.

INSURANCE OF AUTHENTICITY AND TRACEABILITY

Ensuring the authenticity of pharmaceuticals and medical products, and ensuring traceability
are grounds for safe and reliable markets.

BUDGET OPTIMIZATION
With this set of tools, you are able to easily identify all
critical points of budgeting, and you only have to make a decision.
Accurate and simple access to various issues that interest you regarding
market movements over a long period is a unique basis for considering
strategy.

Sg SIGYN
 CUSTOM MADE SOLUTION
Program core is designed with simplicity of adjustment for special needs, specific working
environment and legal framework. Therefore, this solution can answer your needs in the best
way possible.

ACCESS AUTHORIZATION AND CLIENT MANAGEMENT SYSTEM

Authorization to access certain areas of data is divided into more than 20 levels. Users can
only access the areas of the program that suits their level of authorization. All user actions are
recorded in a platforms log. In this way, full traceability and control over the operations,
manegent roles and actions of each user are guaranteed.

DATA SECURITY
Nowadays risks for data security are growing each day. For this reason, we are continuously
tracking trends and implementation of the highest safety standards, so your data is always
safe.

TECHNOLOGY SOLUTIONS AND PREREQUISITS

Software solution is based on the Client Server work technology.
In this way, it enables great flexibility in operation, while simultaneously supervision of the
operation and security are held in accordance with the highest standards. The application is
placed on a specially configured Apache server and client access is controled with security
protocol. Clients access the server using a newer generation web browser and the only
special installation required on the clients computer is a protocol and a authentication certifi-
cate to access the server.

POSSIBILITY OF INTEGRATION AND ADAPTATION

This software solution is suitable for various forms of integration with existing systems that
are currently used in institutions interested in using a software solution or in need of using
data exported from the system. Also, both modular and decentralized architecture software
solution allows easy customization and upgrade of software solutions.

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DRUG REGISTER
Re
Registar
What's it called? How much does it cost? What is the packaging and which
pharmaceutical form, does it have a patent and since when is it on the market?
All this and much more information can be found at hand in our module of drugs
registry.

BENEFITS MODULE
FUNCIONALITY
EASY MARKET MANAGEMENT The main task of this module is to consoli-
Follow the overall drug market from every aspect - from the individual packaging to groups . date all the information about the packages
When the information is complete, market management becomes easier and simpler. that are on the market.
Through its integration with other modules
THE MOST ADVANCED BUSINESS INTELLIGENCE TOOLS will allow simple access to all the informa-
This unique module will provide an overview through the time with the traceability of changes tion that you choose to guide through this
and all the decisions made within the overall system. system. A special advantage is that the data
is organized and prepared in full compliance
IMMEDIATE INSIGHT INTO ALL RELEVANT DATA with legal and legitimate framework, so that
Always be connected. All data, as well as their reports and relevant documents will be the use is adapted to all the needs that
available to you whenever you need them. would be expected of such application.
Search is customized for fast operation, a
simple and intuitive interface will allow the
orientation for persons with only basic

KEY FEATURES
computer knowledge and minimal training.
Data exported from this module is particu-
larly important feature. The possibilities are
numerous, from the export prepared for
DIRECT INSIGHT INTO THE STATE OF THE MARKET publication in the media, to the live channel
This module provides an overview of the drug market its current status, as well as previous feature - which will allow easy connection of
versions of the registry with all available data. other automated applications, systems and
platforms which are essential for the
SPEED AND AVAILABILITY OF DATA operation of the data kept in the register.
Navigate to the desired data instantly with a few mouse clicks. Choose a category for your The module has the features for separated
search - one or more of them and all you need will be displayed on your screen. authorization approach, making it possible
to set the configuration of the user's role in a
EASE OF USE way that will fully protect the existing
This module excels simplicity and intuitive interface adjusted to the needs of hierarchy within the team / teams. With the
daily use, and provides a clear insight into the overall picture. possibility of a separate data display in a
way that users can see only what is in
accordance with the their delegated
authority.
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PRICE REGULATION
Rg
Regulator
The most advanced tools for defining and managing the process of determining,
coordinating and establishing drug prices. This module combines everything
from the international comparative prices to generating models and proposals.

MODULE
BENEFITS FUNCTIONALITY
CONTROL OF PARTICIPANTS IN THE MARKET COMPETITION Automated calculation procedure of interna-
tional comparative prices of drugs in
Controling, monitoring and determening of the final price of medicines by tracking proposals
accordance with the law prescribed methodol-
from manufacturer / authorization holder
ogy for calculating the drug price and
proposing them. System for controling the
MORE EFFICIENT NEGOTIATION OF DRUG PRICES accuracy of comparative international
Simple and quick verification of all types of data, will allow you a significant
package prices:
advantage in negotiating.
The system allows automatic package
grouping in groups of same kind with
TRANSPARENT PROCESS OF PRICE CALCULATION possibility of manual changes afterwards by
Price calculation, regardless of whether it is an international comparative price or referencing, multiple criteria (ATC, the number of unit
now becomes transparent procedure that you can follow and check out at any time. forms in packaging, strength, type of dosage
form, etc.) all changes are remebmered for
the next calculation:
Calculating of the comparative price: - for
KEY FEATURES each group of the same type and for each
country that has adequate packaging
verification of the highest and lowest prices
INSIGHT INTO THE REFERENCE DRUG MARKET and calculation of average values, also with
This module is equipped with a register of drug prices in the reference markets with the ability ability to manually modify the automatically
to browse, search and compare the current and all previous versions. selected values
Ability of manual intervention in the
QUICK AND EASY CALCULATION OF DRUG PRICES calculation selection of the price that will be
What once took months now generates before you in just a few minutes and whenever you taken into consideration, among the ones that
need it. are offered
Importing data about the received price
proposals
FORECASTING AND PLANNING TRENDS ON THE MARKET
Export and import of data in different
Create a customized models calculations by which you will be able to assess and plan the
formats
drug market.
Overview of calcualtion history with details
(which packages are taken into considera-
tion), and much more.
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STATISTICAL ANALYSIS
An
Analiza
Data on sales of drugs can become a very effective tool for negotiations or
development of a strategy, but they can also point to the market anomaly. With
this tool

BENEFITS MODULE
FUNCTIONALITY
PREVENTION OF MARKET ANOMALIES
Monitoring drugs consumption is based on
Find the deviation from the expected flow of traffic of drugs and find out what is the cause of
data that are imported into this platform's
such events.
system. Data can be imported in different
ways. Our platform in this regard is
BUDGET OPTIMIZATION completely adaptable to your needs and the
With this set of tools you will be able to easily identify all critical points of
way in which data is collected
budgeting, and all you have to do is to make a decision.
(half-automated import data from other
applications). Analytical features of this
EVIDENCE BASED STRATEGY BUILDING OF MARKET module are based primarily on the quality of
REGULATOR the data at your disposal. Adequate sizing of
Accurate and easy insight into various issues that interest you regarding the movement of the the data will allow maximum use of the
market over a long period is a unique basis for rethinking strategies. module. Adequate sizing of the data will
allow maximum use of the module.
Monitoring market movements, segmental

KEY FEATURES
display, comparison according to various
criteria will be simple and fast using our
unique interface for viewing and comparing
data. Automated reports are organized
MONITORING DRUG CONSUMPTION according to your needs. According to your
Consumption of drugs can be searched and browsed by search categorys, with
predefined needs automatic reports are
views, projections and calculations of market share.
generated in defined intervals. Reports
follow all the important trends on the market
AUTOMATED ANALYTICAL REPORTS in organized way which will allow you fast
Automated reports are available each day, week, month or year - to and accurate insight, and warn you of the
predetermined criteria and parameters. need for additional action if necessary. The
module has the features for separate
INTERACTIVE ANALYTICAL INTERFACE authorization approach, making it possible
Interactive analytical interface will help you to easily find, compare and to set the configuration of the user's role in a
project the movement of consumption for a particular package, the manufacturer or group of way that will fully protect the existing
drugs. hierarchy within the team / teams.

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PROCESS MANAGEMENT
Up
Upravljanje
Accuracy, traceability and visibility make this module an irreplaceable tool that
will with the help of automated procedures raise the efficiency of administrative
process to a new level

BENEFITS MODULE
FUNCIONALITY
CENTRALIZED MONITORING OF PROCESS Module Process Management provides an
Always accessible and clear presentation of certain processes and objects will allow you to integrated management and administrative
monitor and directly access to the work of teams and the traceability of each data within the management procedures relating to the
system. registry / list of drugs. From receiving the
TRANSPARENCY AND TRACEABILITY OF THE PROCESSES request, opinions and proposals, prepara-
All processes and objects are fully traceable and transparently presented. In this way all the tion of documents and the decision-making
questions find their answers. bodies to the final documents and actions.
Directly from this module, it is possible to
EASY MANAGEMENT OF ADMINISTRATIVE PROCEDURES modify the entire list of drugs in the register
by clicking the mouse. The module will be
Management of administrative procedures is sometimes time-consuming and tiresome. With
fully customized to your needs and
the help of our platform it becomes simple and easy.
procedures, so that it will not be necessary
to change the existing way of working just
make it simpler and easier to manage. The
module has the features for separate
KEY FEATURES authorization approach, making it possible
to set configuration of user roles in a way
that will fully protect existing hierarchy within
DOCUMENT MANAGEMENT SYSTEM the team / teams. With the possibility of a
Monitoring of the entire process, from receiving demand through the decision making and separate display data in a way that users
evaluation, to the issuance of the decision. This system will provide an simple and complete can see only what is in accordance with the
insight. delegated authority.
AUTOMATED GENERATING OF DOCUMENTS
Separating the important from the less important is key to success. Let your professionals
make decisions and implement them throughout the system by clicking the mouse.

INTEGRATED MANAGEMENT PROCESS

Do not waste any more time searching for documents. Now everything is in one place, clear
and easily accessible.

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AUTHENTICITY INSURANCE
Sc
Security
Control system and assurance of the authenticity of pharmaceuticals and
medical products, as successful solution to protect market from the appearance
of of counterfeits in accordance with EU directive 2011/62/EU adopted

BENEFITS TECHNOLOGICAL
SOLUTION
PROTECTING THE MARKET OF FORGERY Production of safety labels is a complex
This solution is fully in accordance with the EU directive 2011/62/EU adopted 08.06.2011,
process that requires experience, knowl-
which protects the drugs and medical products market against the appearance of forgery.
edge, cutting-edge technology, and
implementation of the highest safety
REMOVAL OF THE HEALTH RISK standards in manufacturing. Our solution
Counterfeits, inauthentic products, drugs and medical devices that do not meet the provides protection at multiple levels,
prescribed criteria represent a major risk to the health of users of health care. depending on the client's needs.

TRANSPARENCY AND ACCESSIBILITY OF THE SYSTEM

Each participant in the system of physicians, wholesale drugstore, manufacturers, all the way
to the customer can check and find all the relevant information about a particular product
packaging protected by security vignette in a simple way.

Basic protection segment is respesented by

KEY FEATURES the specific tehnologies of the label it can not

be taken of without tearing which ensures
non-transferability. Unique code provides easy
UNIQUE SAFETY PROTECTION LABEL access to information about the packaging and
contents, and simple authentication via a
Each product on the market is marked by a unique protective sticker - vignette. Vignettes are
central information system.
made by the newest and most demanding saftey standards for protection and quality
assurance.
CENTRAL SYSTEM FOR ISSUING PROTECTION LABEL
A system for the issuing the labels is under the direct supervision of drugs and mediacal
products regulator.

INFORMATIONAL PROTECTIVE CODE Holographic protection, produced by

Each label is equipped with informational protective code. This code allows modern standards further protects the
simple check of required data - the validity period, the number of approvals, importers, security label of forgery and is an additional
Manufacturers, wholesale drugstore, to the retail stores. level of security of our system. This solution
meets the most demanding standards of
quality assurance.
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TRACEABILITY
Tr
Traceability
Traceability of pharmaceuticals and medical products on the market is one of the
basic conditions for security of the whole market. Apart from security, the system
for ensuring tracebility provides a valuable source of information for tracking the
movement of the market.

BENEFITS ENSURING THE

TRACEABILITY
TRACEABILITY We can all agree that quality assurance of
Traceability of each packaging of drugs and medical products from manufacturers or
drug an medical products market has no
importers, through wholesale and retail to the final customer.
alternative. Protection of accuracy,
authenticity and tracebility of products are
ACCURATE INSIGHT INTO THE CURRENT STATE foundations for quality assurance system.
This system provides a simple and accurate insight into the current state and position of each This module manages exactly that segment.
package on the market.

COMPLETE TRACKING OF THE MARKET AND TRANSPARENCY

Reduced demand and significantly simpler enforcement and control of the market and
participants of drug and medical products market.

This module is a system which integrates

cutting-edge technology and innovative

KEY FEATURES solutions to monitor the traceability and

quality assurance. Methods and elements
used in the operation of this module
CENTRALIZED SYSTEM FOR MARKET MONITORING guarantee reliability and meet the highest
Central information system that monitors the movement of all packages of drugs and medical standards, appropriate for use in the health
products in real time according to their unique security codes. system.

PROCESS CONTROL POINTS

Control points from the entrance of each package on the market, to the final customer.
In each segment, providing instant access to the number, type and packaging forms that are
at particular point.
TRACEABILITY ACCORDING TO THE UNIQUE CODE This module provides a minimization of risk
For each code issued we can make simple check of traceability and status. for drugs and medical products market. By
This query produces data from when packing entered the market, and all the way to the implementing our solutions, drugs and
current situation - where it is currently located inside the packaging system. medical products market exceed to the
higher level of security and reliability.

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SECURITY LABELS
Displaying safety labels management process for drugs and medical
AGENS products, from seeking approval to the market.

1 The manufacturer or importer of drugs and medical products requests authoriza-

tion for release of drugs and medical products on the market.
IMPORTER
MANUFACTURER

Agency for Medicinal Products and Medical Devices issues approval for the

2
requested medication or medical products. Assigning protective sticker in accord-
ance with the approval to the wholesalers, importers or manufacturer.
MEDICINES
AGENCY

According to permits issued, the printing office prints the exact amount of

3
personalized protective unique label for each package.

PRINTING
OFFICE

Pasting labels on the packaging of the drug or medical product is performed by

4 the manufacturer or importer before the release of drug or medical product on

the market.
IMPORTER
MANUFACTURER

Packages protected by the security label are entering the market of medicines

5 and medical products, wholesale and retail.

WHOLESALE
PHARMACIES

Medicines Agency performs active surveillance of drugs and medical

6 products on the market.

MEDICINES
AGENCY

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Sg SIGYN AGENS

VIEW OF THE MODEL

Model of impementation for ensurance of authenticity and traceability of medicines
and medical products market. This method of managing the drug market not only
provides a high level of quality care, but also largely achives preconditions for high
quality data collection on trends in the drug market, and thus makes a valuable basis
for the market regulation systems.

MEDICINES AGENCY
THE MARKET REGULATOR

PHARMACEUTICAL ISSUING
SAFETY LABELS
INDUSTRY
At the request of the
MANUFACTURERS AND IMPORTERS
manufacturer or importer of
drugs, the agency issues a
limited series of safety labels

SECURING THE PRODUCTS DATA COLLECTION

WITH LABELS IN THE CENTRAL SYSTEM
Manufacturers and importers Data on turnover of drugs and
ensure packaging with safety medical devices are
labels before entering the integrated into the central
market system

PHARMACEUTICAL WHOLESALER PHARMACIES END USERS

DISTRIBUTORS RETAIL NETWORK

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SIGYN AGENS

m1 m2 m3 m4

Re Rg
Registar Regulator
An Up
Analiza Upravljanje

m1 m2

Sc
Security
TrTraceability

ABOUT US
Agens company was established in year 1990, from then until now
we dedicate our highest attention to improving and ensuring the
quality of our products as evidenced by the certificate ISO 9001.
Throughout continuous and controlled growth we earned certification
of most creditworthy excellence AAA and by that we are classified
into 2% of Croatian companies.
CONTACT
Agens d.o.o.
Medarska 69, 10090 Zagreb - CRO
Phone: +385 1 3862 830, Fax: +385 1 3862 825
E-mail: prodaja@etikete-agens.hr

Sg SIGYN
ABOUT US
Sigyn company resarch and development d.o.o. founded in year
2010 with the goal of finding innovative and integrated solutions in
specific forms of business.

CONTACT
Sigyn - research and development d.o.o.
Trg rtava faizma 3, 10000 Zagreb
Phone: +385 91 254 99 45
email: miron@sigyn.eu

AUDENTA CONSULTING
ABOUT US
Audenta consulting firm was founded in 2011 with the goal of
consulting related to the business and management in health care
and health insurance with a special focus to the application of
advanced technologies in the health care system.

CONTACT
Audenta consulting d.o.o.
Savska cesta 141, 10 000 Zagreb
Phone: +385 (0) 99 311 0387
E-mail: audentasavjetovanje@gmail.com