Stefan Moch
YOUR CONTACT
Stage_Fälschungssicherheit

Counterfeit Protection in the Life Science Industry

Efficient IT solutions for secure trade in pharmaceuticals 

Use Case
Benefits
References
Our Services
Downloads

Protecting medicinal products against counterfeiting has been the focus of political attention for several years. To effectively protect consumers, markets, and manufacturers, a legal framework for the protection against counterfeiting has been created. With the EU Directive 2011/62/EU (Falsified Medicines Directive) and further technical elaboration through the Delegated Regulation 2016/161/EU, the European Commission has laid the foundation for combating counterfeit medicines in the legal supply chain. 

Technical solutions for pharmaceutical companies and the national organizations for the authenticity testing of medicinal products, are to ensure protection against counterfeiting. Arvato CSDB and NMVS ensure throughout the EU that prescription drugs are sold only as originals throughout the EU. 

Use Case

Your Challenge

Since 2019, the EU Falsified Medicines Directive stipulates that prescription medicines may only be circulated if the packaging bears individual features such as a serial number. To meet these requirements, pharmaceutical companies and organizations in EU countries must use IT solutions to authenticate medicines.

The Vision

Pharmaceutical companies and so-called NMVOs (National Medicines Verification Organizations) need an innovative implementation option for the political requirements. The IT solutions must be able to be used securely, cost-efficiently, and quickly, so that pharmacies can issue prescription drugs to consumers throughout the EU in a way that prevents counterfeiting..

Our Solution

The European Medicines Verification Organization (EMVO) officially appointed us as a National Blueprint Service Provider. This means that we offer NMVOs a proven option for implementing all aspects of the various anti-counterfeiting guidelines. We also use a serialization solution to implement all legal requirements on the pharmaceutical company side. 

Benefits for You

Secure Data Exchange

We enable reliable exchange of serialization data. 

Simple Integration

The simple connection via standard interfaces. 

Reliable Documentation

We provide reliable reporting of all serialization events. 

Good Connectivity

Our solutions seamlessly connect to existing systems (e.g., ERP & MES). 

Line-integration

You get the possibility of a flexible connection to line manufacturers. 

Compliant

The solutions are perfectly tailored to national and international regulations. 

References

Arvato CSDB Migration to Virtual Private Cloud for STADA
Arvato CSDB Optimization for Aenova
Arvato CSDB for Dr. Pfleger

Our Services for Your Success

  • Our Arvato CSDB solution unites production lines, partners, customers, and suppliers. We support you with our technical expertise and process know-how throughout the entire serialization process. The serialization solution unites all parties involved - from the production lines to the customer - and includes integration, all security components, and adaptation of processes for the secure drug trade. 

  • To enable NMVOs to meet regulatory requirements, our National Medical Verification Systems includes services such as uploading and storing master and serialization data via the EU Hub, including connection to the Hub for exchange between the respective systems. In addition, the system processes verification requests from pharmacies and wholesalers. 

Downloads

Arvato CSDB White Paper

Learn more about serialization with Arvato CSDB in our whitepaper. Simply fill out and download it free of charge.

You May Also Be Interested In

National Verification Systems

Arvato Systems provides European countries with a National Blueprint Service to verify medicines.

Global Update on Drug Serialization

The regulatory process for drug serialization has been completed in Bahrain, Uzbekistan, and the United Arab Emirates. Other health ministries are now planning how to effectively protect consumers with drug serialization laws.

What Is Serialization in Drug Production?

The illegal trade in counterfeit products is a sad part of everyday life in the pharmaceutical business. With the help of a serialization solution, this problem can be eliminated in the long term. But what exactly is serialization in drug production?

Your Contact for Counterfeit Protection in the Life Science Industry

Stefan Moch
Stefan Moch
Expert for Anti-Counterfeiting in the Pharmaceutical Industry