Introduction
Ensuring the authenticity is a critical responsibility in today’s global pharmaceutical market. As medicines move through complex international supply chains, the risk of counterfeit, falsified, or diverted products entering legitimate distribution channels remains a significant concern. These threats compromise patient safety, weaken trust in healthcare systems, and expose companies to significant regulatory and commercial risk.
Marketing Authorisation Holders (MAHs) are legally accountable for ensuring that every medicine placed on the market is genuine, traceable, and compliant with anti-counterfeit regulations. Through pharmaceutical serialization, medicine authentication systems, and robust track-and-trace compliance, MAHs play a central role in protecting product integrity and maintaining global supply chain security.
Role of Marketing Authorisation Holders (MAHs)
The Legal and Regulatory Responsibilities
Marketing Authorisation Holders are the entities legally responsible for placing medicinal products in each jurisdiction. Regulators across regions hold MAHs accountable for ensuring that products remain authentic, compliant, and safe throughout their lifecycle, including control over any serialization or packaging activities
Key responsibilities include:
- Implementing pharmaceutical serialization in line with regional laws and standards such as EU, FMD, DSCSA, and GS1.
- Ensuring unique identifiers are correctly applied to saleable units with accurate product, batch, and expiry data.
- Uploading and maintaining accurate product and serialization data in national and international repositories.
- Enabling medicine authentication at defined points in the supply chain.
- Maintaining traceability and event records to support audits, recalls, and investigations.
Under frameworks such as the EU Falsified Medicines Directive (FMD) and the UK's retained FMD requirements, MAHs must ensure that serialized data is available for verification before medicines reach patients. Even when serialization operations are outsourced to CMOs or third‑party providers, the MAH retains ultimate responsibility for data quality, system validation, and compliance.
Cross-Functional and Partner Oversight
MAHs must also ensure that contract manufacturers, repackagers, distributors, and logistics partners follow compliant serialization and verification processes. This requires strong governance, validated systems, and continuous data exchange across the global supply chain.
Challenges in a Global Pharmaceutical Supply Chain
Counterfeit and Falsified Medicines
Counterfeit and falsified medicines remain a persistent global threat, affecting both high-value speciality products and widely used essential medicines. Criminal networks exploit regulatory gaps, complex distribution routes, and weak verification controls to introduce falsified products into legitimate channels. High-value and high-demand medicines are particularly vulnerable to diversion and counterfeiting.
Parallel Trade and Cross-Border Distribution
Parallel trade and cross-border distribution introduce additional complexity for MAHs. Medicines may be repackaged, relabelled, or redistributed across jurisdictions with different regulatory requirements, increasing the risk of data inconsistencies and authentication failures. This complexity is amplified by different rules repackaging, relabelling and re-serialization in each market.
Fragmented Regulatory Requirements
Global markets operate under different serialization and track-and-trace frameworks, including the EU FMD, U.S. DSCSA, UK requirements, and emerging regulations in Asia, the Middle East, and Latin America. MAHs must manage these variations while maintaining consistent medicine authenticity controls and high-quality data.
Regulatory Expectations for Medicine Authenticity
European Union - Falsified Medicines Directive (FMD)
The EU FMD requires most prescription medicines to carry safety features on the packaging, including:
- A unique identifier encoded in a 2D DataMatrix barcode linked to product code, serial number, batch, and expiry.
- A tamper-evident device.
These features enable the authentication of medicines at the point of dispensing through the European Medicines Verification System (EMVS).
United Kingdom Requirements
Following Brexit, the UK has moved to a UK-wide framework for medicines regulation and supply under the Windsor Framework. From 1 January 2025, EU FMD safety features requirements and EMVS connectivity no longer apply to medicines marketed and supplied anywhere in the UK, including Northern Ireland.
Global Standards and Other Markets
In the United States, the Drug Supply Chain Security Act (DSCSA) mandates interoperable, electronic, unit-level track-and-trace systems across the prescription drug supply chain. Trading partners must exchange serialised product identifiers and event data to enable verification, tracing, and rapid response to suspect products.
Other regions, including parts of Asia, the Middle East, and Latin America, are implementing similar serialization-based requirements, often grounded in GS1 standards for identifiers and data exchange. This reinforces the global expectation that MAHs use serialization and electronic track-and-trace as foundational tools for medicine authenticity.
Technology's Role in Ensuring Authenticity
Pharmaceutical Serialization
Pharmaceutical serialization assigns a unique serial number to each saleable unit, linked to critical product data such as product code, batch number, and expiry date. This unique identifier forms the foundation of medicine authenticity by enabling verification and traceability across the supply chain.
Track and Trace Compliance
Track-and-trace systems record the movement and status of serialized products from manufacture through distribution to dispensing or final decommissioning. These systems allow MAHs to:
- Detect suspicious or duplicate serial numbers and anomalous event patterns that may indicate falsification or diversion.
- Prevent unauthorised product diversion by monitoring product flows between markets, wholesalers, and distributors.
- Support rapid and targeted recalls by identifying affected batches, locations, and trading partners through event histories.
- Demonstrate regulatory compliance during inspections.
Together, serialization and track-and-trace compliance significantly reduce the risk of counterfeit medicines entering legitimate supply chains and provide MAHS with evidence of control over their products.
How Scan Plus Supports MAHs
Scan Plus is a pharmaceutical serialization and compliance platform designed to help MAHs and their partners meet global medicine authentication and anti-counterfeit requirements. It streamlines collaboration between MAHs and CMOs, centralises serial number and product data, and supports compliance across EU, US, GCC, and other regulated markets.
Pharmaceutical Serialization Solutions
Scan Plus supports end-to-end serial number management, enabling MAHs to generate, manage, and exchange serialized data across manufacturing and distribution networks while aligning with global regulatory standards. The platform:
- Configures and tracks MAHs, CMOs, products, batches, and serial ranges in a single environment, providing a single source of truth for serialization data.
- Delivers serial numbers in flexible formats, including SOAP services, CSV, and Excel, to integrate with diverse packaging lines and partner systems.
- Supports EU serialization integrations and other regional models, helping MAHs keep pace with evolving global requirements.
Medicine Authentication Systems
By supporting accurate application and verification of unique identifiers, Scan Plus enables secure medicine authentication and helps ensure that only genuine products move through authorised supply channels.
Track and Trace Compliance
Scan Plus facilitates track-and-trace compliance by maintaining structured, auditable records of serialized product movements, supporting regulatory inspections, recalls, and ongoing supply chain oversight.
Anti-Counterfeit Technology for Pharma
Through centralized data control, compliance reporting, and system interoperability, Scan Plus helps MAHs strengthen anti-counterfeit controls and protect medicine authenticity across global markets.
Conclusion
Medicine authenticity is no longer a regional or operational concern; it is a global regulatory obligation and a core element of patient safety. Marketing Authorisation Holders must adopt proactive strategies that combine regulatory expertise, strong partner governance, and robust serialization and track-and-trace technologies.
By implementing comprehensive medicine authentication systems and leveraging compliant platforms such as Scan Plus, MAHs can protect patients, safeguard brand integrity, and meet evolving global anti-counterfeit regulations with confidence.