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Arvato CSDB - Frau prüft Seriennummern auf Medikmanenten

Serialisation in Drug Production

Arvato CSDB Serialises - Securely & Legally Compliant.

Arvato CSDB - Core Functionalities
9 Good Reasons
Other Business Solutions
Why Arvato Systems
Deep Dive

Protection Against Counterfeit Drugs

Produktlogo arvato CSDB

According to the WHO, the trade in counterfeit medicines affects all countries worldwide and is increasing massively. At best, counterfeits are ineffective for end consumers - and in the worst case, they are life-threatening.

In order to effectively protect consumers, markets and manufacturers from counterfeits, a legally binding framework for tracing prescription-only medicines was created, for example, with the EU Falsified Medicines Directive (FMD) of 2011 and the Delegated Regulation (EU) 2016/161. Among other things, data matrix codes, database comparisons with national verification systems and solutions for detecting the integrity of product packaging (Tamper Evident sealing) are used.

Arvato CSDB - The Solution for Pharmaceutical Companies

A central element in the fight against counterfeit medicines is digitisation. The Arvato CSDB is used as a proven serialisation solution by over 80 pharmaceutical companies and ensures both a smooth serialisation process and the seamless implementation of legal requirements.

Arvato CSDB - Core Functions at a Glance

Drug serialisation is much more than a code on the package. Nationally as well as internationally, manufacturers and distributors have to meet the legal requirements regarding counterfeit protection.


The serialisation solution must integrate production lines, partners, customers & suppliers - this means comprehensive integration, adaptation of processes and high security measures. Whether at the intersections between ERP software and production and packaging machines, to the systems of external service providers or to national verification systems: The serialisation of medicines requires technical expertise, process know-how and the software solution Arvato CSDB, which reliably controls the entire serialisation process.

Arvato CSDB - Funktionsübersicht Medikamentenserialisierung

Download White Paper "Serialization In Drug Production"

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Solutions & Consulting Expertise for the Pharmaceutical Industry

Importance of the topic of serialisation for market participants such as pharmaceutical producers, contract manufacturers, marketing authorisation holders or wholesalers.

Marketing authorisation holder (MAH)

Contract manufacturing organization (CMO)

Pharmaceutical Wholesalers

National Verification Systems (NVS)

Pharmaceutical industry active in Russia

As a marketing authorisation holder, you must continuously be aware of and implement global regulatory developments with regard to serialisation, aggregation and tracking requirements. In particular, sometimes very extensive reporting requirements must be taken into account when implementing the respective solutions, this applies both to local production in an affected market, but also to exports to affected markets. The Arvato CSDB solution modules ensure stable mapping of the necessary processes and smooth integration with the regulatory systems.


Regardless of whether you produce yourself and/or have your products manufactured by CMOs, due to the necessary exchange of serialisation data, your challenges include in particular the integration and interaction with your CMOs and/or production or packaging lines. The request-based provision of serial numbers to and subsequent reporting from your CMOs is carried out quickly and reliably via our network. Proven connectors for the well-known hardware manufacturers are also available for the connection of the lines.

For you as a contract manufacturer, efficient and lean serialisation processes are of particular importance. Due to the necessary exchange of serialisation data, your challenges include in particular the integration and interaction with your (numerous) customers on the one hand and with production and packaging lines on the other. The request for serial numbers from and the subsequent reporting to your customers is carried out quickly and reliably via our network. Proven connectors for the well-known hardware manufacturers are also available for the connection of the lines.

According to the EU Falsified Medicines Directive (FMD), pharmaceutical wholesalers are also required to physically verify existing products and to decommission them if necessary.


Our experience in the digitalisation of business processes in the logistics sector helps licensed pharmaceutical wholesalers to implement the necessary process changes quickly and precisely. At the heart of the solution is the Arvato Smart Logistics Platform - Healthcare Suite - part of our proven platform platbricks, which ensures smooth operations in over 40 companies every day.

Our Serialisation & Anti-Counterfeiting team is an official service provider of the European Medicines Verification Organisation (EMVO).


We supply National Verification Systems for 17 countries in Europe - including securPharm in Germany, France MVO, SecurMed UK or SEVEM - and successfully connect them to the EU Hub. As an EMVO-certified supplier of national blueprint systems, we are always up to date with international regulations.

Pharmaceutical Industry active in Russia

Similarly to the countries of the European Union and the United States, for example, Russia has also developed a system for serializing medications. With regard to the timeframe, the transition period for the mandatory marking and reporting of pharmaceuticals to the state information system was extended from January 1, 2020 to July 1, 2020. 


We provide you with a detailed white paper on "Serialization of Medications in Russia", in which we explain how companies in the pharmaceutical industry can use our know-how to meet the ambitious requirements in order to continue to operate in Russia.

9 Good Reasons for the Arvato CSDB

The standardised ...

  • SECURE - reliable exchange of serialisation data with external partners.
  • FLEXIBLE - simple connection via standard interfaces.
  • SEEMLESS - fast and complete integration into existing IT landscapes.

integrative …

  • TRANSPARENT - reliable reporting of all serialisation events.
  • SIMPLE - seamless connection to existing systems (e.g. ERP & MES).
  • OVERARCHING - use at both site and line level.

Solution for Drug Serialisation.

  • COMPREHENSIVE - management of complex workflow processes.
  • INTERNATIONAL - perfectly tailored to national and international regulations.
  • CONNECTING - flexible connection to all important line manufacturers.

Other Business Solutions

National Verification Systems

platbricks Healthcare Suite For Pharma Wholesalers

Why Arvato Systems

Serialisierung in der pharmazeutischen Industrie mit Arvato CSDB - Kundenlogos

Today, our serialisation experts support pharmaceutical manufacturers and retailers worldwide in making medicines counterfeit-proof with IT consulting/process consulting and our own software solution Arvato CSDB (graphic: excerpt customer list).

Our expertise in the healthcare segment covers the entire serialisation process chain end-to-end, from the product to the end customer. Other in-house developments, such as the platbricks Healthcare Suite, offer additional opportunities to optimise processes and expand existing systems.

17 European countries have entrusted us with the operation of their National Verification Systems. The associated regulatory know-how ensures that our customers always have up-to-date processes/systems and thus investment and action security in a complex market.

System Change: Migration in Less Than 8 Weeks

Focus Reference: Horus Pharma

Together with the Horus Pharma team, our specialists successfully replaced the legacy system for drug serialization with our proven and flexible solution Arvato CSDB (Software as a Service) within a few weeks.

Successful In the Pharmaceutical Industry: This Selection of Customers Already Relies on the Proven Serialization Solution Arvato CSDB

Serialization

Aenova Group implements the requirements of the Falsified Medicines Directive with the help of the Arvato CSDB IT serialization solution

Safety for patients

Aristo Pharma serializes with Arvato CSDB.

FMD-compliant

Application of the serialization solution Arvato CSDB at Basic Pharma.

Serialization: Efficient & Secure

Bausch & Lomb uses Arvato CSDB for serialization.

Implementation in Record Time

BRIZ Ltd with the help of Arvato Systems compliant with the EU Falsified Medicines Directive regulations in record time.

Traceability of medicines

Chanelle Pharma serializes with Arvato CSDB.

Delorbis Pharmaceuticals Ltd
Serialization in the pharmaceutical industry

Drug protection with the Arvato CSDB with Dr. Falk.

Protection for end users

Serialization for counterfeit protection: Arvato CSDB at Dr. Kade.

Counterfeit proof medicines

Implementation of Arvato CSDB - IT solution for successful drug serialization according to the Falsified Medicines Directive

EU-FMD compliant

Genericon relies on serialization solution Arvato CSDB.

Safe Medicines

Serialization solution Arvato CSDB in use at Gerot Lannach.

In Less Than 8 Weeks to the New Serialization Solution

Horus Pharma changes serialization solution in record time

High safety requirements also in Spain

Our serialization solution Arvato CSDB in use at Laphysan.

Accurate Traceability of Medicines

medac with Arvato CSDB against counterfeit drugs.

Knowing where the drugs come from

Mylan successfully implemented serialization solution from Arvato Systems.

Drug Protection

Pharma Stulln serialized with the Arvato CSDB.

Against product piracy

At the heart of the Netherlands: Royal Herkel serializes with Arvato Systems

Serialization in dentistry

Counterfeit protection at Sigma Dental.

Medication safety

Successful serialization in medicine production with the help of Arvato CSDB

Solution for Pharmaceutical Logistics

Arvato Systems uses logistics solution to fulfill FMD at Yusen Logistics.

Safe Medications

Wörwag Pharma uses the serialization solution Arvato CSDB.

We Rely on Strong Partners

Eqeep Consulting B.V.
Körber Pharma
WIPOTEC-OCS

Deep Dive

How to Successfully Switch to Arvato Csdb - Watch Web Session Now!

WEB SESSION: Find out how you can easily and safely replace your existing serialization solution with the Arvato CSDB within a very short time - all the important information is presented for you in a compact and clear manner.

Serialization in Drug Production

White Paper: Interesting background information about the development and the hazards of drug forgery, EU legislation as well as worldwide initiatives and their practical implementation process of serialization can be obtained in our White Paper. 

Serialization of Medications in Russia

White Paper: The MDLP system operated by the Russian company CRPT is the only one of its kind in the world in terms of its scope and complexity. The Russian legislature and the numerous guidelines it stipulates pose a great challenge to manufacturing and selling companies. Download our latest White Paper and learn, among other things, details on how crypto code works, helpful background information, and how you can draw on our many years of expertise and proven IT solutions to implement the serialization of medication for the Russian market by the applicable deadline.

Serialization readiness in the drug production

Checklist: As a CMO or a MAH, you need to deal with the already existing as well as the future requirements. We enable you by proving the checklist to gain a valuable overview of the most important topics, with which you should deal and gain clarity.

Digital Identity Food & Food Supplements

WEB SESSION: From 2022, it will be mandatory for food and food supplements to bear certain serialization features for export to Russia. The central Russian track & trace system is considered one of the most complex in the world.

Business Solution Drug Serialisation

SOLUTION FLYER: Overview and information on the Business Solution "Arvato CSDB" - core functions as well as the topics External Partners, National Verification Systems, Production Sites, Internal Processes in key points.

Healthcare and Pharma - News From Our Blog

Counterfeit Products in the Field of Food Supplements

The market for food supplements is attractive for black sheep. The reason is obvious: sales are booming. The fatal: By definition, these are considered food, not drugs. They are subject to less stringent controls & standards that also apply to food.

No Fear of Changing the Serialization System

A majority of pharmaceutical companies have spent a very large amount of time and effort in recent years implementing or upgrading new hardware, software and processes to comply with the mandatory serialization requirement.

Kim: The New Digital Communication Standard

Until now, there has been no secure electronic transmission procedure linking these professional groups in the healthcare sector. From now on, a new digital communication standard will fundamentally change that: KIM - Communication in Medicine.

The Dangerous Business with Counterfeit Drugs

Counterfeit medicines cost the national economy billions. For this reason, the counterfeit protection of pharmaceutical and medical products belongs on the (social) political agenda.

Your Contact for Healthcare & Pharma

MA_Carl Rainer Stetter_Commerce
Carl-Rainer Stetter
Expert for Counterfeit Protection in the Pharmaceutical Industry