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Addressing the Challenges of Serialisation

Drug counterfeiting poses a significant threat to the pharmaceutical industry, risking patient safety and undermining the integrity of the global supply chain. As illicit activities continue to evolve, with counterfeit drug seizures in 2021 increasing 101% over the previous year,1 pharmaceutical companies face a pressing need for robust solutions to combat counterfeit drugs.

Serialisation has been a powerful weapon in the battle against counterfeiting for over a decade, and regulations offer a systematic approach to product tracking and authentication. By assigning unique identifiers to each unit of a product as a regulatory requirement, serialisation has been a comprehensive means of ensuring the authenticity and traceability of pharmaceuticals throughout the supply chain, from factory to patient.

Serialisation frameworks, such as the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) – with its impending phase II changes – act as safeguards against counterfeit drugs for their respective pharmaceutical markets.

Additionally, flexibility in the supply chain, cost-effective manufacturing and labelling processes, collaboration with external experts, and the benefits of partnering with contract packaging organisations (CPOs) in the implementation of serialisation measures are vital to pharmaceutical integrity. Non-compliance with these serialisation requirements may lead to penalties, market restrictions and compromised patient safety.

In this article, Patrick Ferguson, Managing Director TPU, explores the evolving landscape of serialisation and its implications for the pharmaceutical industry.

Worldwide Serialisation Legislation and Directives

Regulations regarding serialisation vary from region to region and from market to market, making compliance a complex affair for pharma companies looking to operate internationally. The key facts that all pharma companies need to be aware of include:

International requirements

• Language variations

• Country specific regulations and serialisation guidelines

• Unique data elements

• Formatting requirements

• Submission processes

• EU legislation complexity

The EU FMD was established to ensure a consistent level of harmonisation across member states and address the growing threat of counterfeit drugs, placing the onus on pharmaceutical manufacturers to integrate serialisation into their operations. These directives were first adopted by the European Parliament and Council in 2011 and they outline the requirements and timelines for serialisation compliance. The final part of the directive came into effect in 2019 and concerned the following safety features:

• Unique identifiers: A 2D data matrix code and legible information placed on medical products that can be scanned at fixed points along the supply chain

• Tamper evident features: Anti-tampering devices on the packaging

Manufacturers operating in the EU are required to comply with these directives and regulations, ensuring that their products are serialised and traceable at every stage of the supply chain.