What is the Falsified Medicines Directive and who does it affect?

The Falsified Medicines Directive requires pharmaceutical manufacturers to provide each medicinal package with a unique DataMatrix code and a tamper-evident feature. MedTracker ensures full compliance – for pharmaceutical manufacturers, CMOs and MAHs, wholesalers, repackers, and logistics providers across all relevant markets.

What is DSCSA and in how many countries does MedTracker support serialization?

The Drug Supply Chain Security Act (DSCSA) is the US equivalent of the European Falsified Medicines Directive. MedTracker supports DSCSA as well as further international serialization regulations in over 20 countries worldwide.

What does aggregation mean?

Aggregation describes the seamless capture of the packaging hierarchy – which individual packs are contained in which bundle, carton and pallet. MedTracker supports full aggregation at every level for end-to-end traceability.

How does MedTracker support connection to national and international verification systems?

MedTracker connects directly and automatically to the respective national verification systems. All required serialization data is transmitted by the system without manual intervention – keeping your production processes lean and audit-ready.

How long does MedTracker implementation take?

Implementation duration depends on the complexity of your production environment. SeriSoft accompanies you through every step of pharmaceutical serialization – from analysis of your existing systems to full go-live with continuous support and monitoring.

Pharma Serialization

MedTracker

Pharma serialization & compliance - Medicine authentication for patient safety worldwide.

With over 10 years of industry experience and BSFZ certification, SeriSoft is your partner for pharma compliance worldwide.

Get consultation All Solutions

FMD

IFA-Code / GS1-Code

DSCSA

California Code / E-Pedigree

China Code

GS1-128C / Plain Text Structure 7/13

20+ Countries

Global Regulations

100%

Regulatory Compliance

30+

Installations

10+

Years Pharma Experience

24/7

Monitoring & Support

The Problem

Counterfeit Medicine

Counterfeit pharmaceuticals have become an extremely lucrative business over the past decades and are increasing rapidly worldwide. Fake medicines pose a serious threat to public health and safety, making effective and comprehensive anti-counterfeiting strategies more important than ever.

To address this issue, regulatory authorities around the world have introduced legal frameworks aimed at controlling and reducing pharmaceutical counterfeiting. While different countries and regions follow their own approaches, they share one key element: the use of unique product identifiers and serialization codes on every individual packaging unit. These enable reliable authentication of medicines and play a crucial role in ensuring product integrity, consumer protection, and patient safety.

The Solution

MedTracker

MedTracker provides a flexible and powerful pharmaceutical authentication solution designed to help companies efficiently meet current regulatory requirements. Thanks to its seamless integration into existing production processes and software systems, MedTracker enables reliable serialization and track-and-trace implementation while optimizing operational efficiency.

Full Compliance
High Flexibility & Open Interfaces
Aggregation at all Levels
Global Market Coverage
Highly Secure System Architecture

Your Benefits with MedTracker

Authenticity & Anti-Counterfeiting

Each packaging unit is uniquely identified – counterfeits are reliably detected and removed from circulation.

Traceability & Transparency

Seamless tracking of every medicine from manufacturer to pharmacy and patient.

High-Security Architecture

MedTracker is based on a highly secure infrastructure meeting the strictest international security standards.

Product Safety & QA

Automated inspection processes ensure product integrity at every stage of the supply chain.

Strengthening Customer Trust

Patients and pharmacies can quickly and easily verify the authenticity of every medication.

Logistics & Inventory

Precise inventory monitoring and optimized logistics processes reduce costs and error sources.

Compliance & Regulations

MedTracker supports all current and upcoming regulatory requirements in all international export markets.

Open Interfaces & Integration

Seamless integration into existing ERP, MES and production systems via standardized interfaces.

Returns & Re-Exports

Unique product identification simplifies and significantly accelerates return and re-export processes.

Digital Technologies

Support for modern digital technologies such as QR codes, DataMatrix and digital product passports.

Competitive Advantages

Compliance-safe serialization gives you advantages over competitors in regulated markets.

Regulations

Country-specific Regulations

MedTracker supports existing and upcoming regulatory requirements in all international export markets – fully and automatically.

FMD

IFA-Code / GS1-Code

DSCSA

California Code / E-Pedigree

China Code

GS1-128C / Plain Text Structure 7/13

Use Cases

MedTracker Use Cases

MedTracker is used worldwide by pharmaceutical manufacturers, CMOs and MAHs – for EU-FMD compliance, DSCSA serialization and global traceability.

Pharma Manufacturers & MAHs

Manufacturers and Marketing Authorization Holders (MAH) use MedTracker for full EU-FMD and DSCSA compliance. All serialization data is automatically transmitted to national verification systems (EMVS).

Contract Manufacturing Organizations (CMOs)

CMOs serialize on behalf of multiple MAHs – MedTracker supports multi-tenancy, batch management and complete per-client audit trails.

Wholesalers & Distributors

For wholesalers, MedTracker provides verification and traceability along the supply chain – from manufacturer intake to pharmacy dispensing.

Re-Export & Parallel Trade

Re-exports and repackaging require re-serialization. MedTracker supports the complete process including de-commissioning and re-commissioning as well as EMVS connection.

Why SeriSoft?

Why SeriSoft for Pharma Serialization?

For more than 30 years, SeriSoft has stood for innovative solutions in serialization, personalization, and track & trace. As a globally active, BSFZ-certified specialist, SeriSoft supports companies in reliably and efficiently meeting regulatory requirements across numerous markets. The highest security standards, end-to-end compliance, and decades of industry expertise make SeriSoft a trusted partner for demanding authentication and traceability solutions.

10+

Years of pharma experience

30+

Installations