Counterfeit medicines have been a growing problem globally, undermining public health, causing many deaths, contributing to organised crime, and adversely affecting both the reputation and bottom line of pharmaceutical companies.

For example, according to the World Health Organisation, 10 percent of medicines sold worldwide are counterfeit, counterfeit medicines are 20 percent more profitable than heroin, and according to the OECD, counterfeit malaria and TB medicines alone are responsible for more than 700,000 deaths a year.

In response, countries globally have been implementing serialisation regulations to tackle the counterfeiting or the falsification of drugs.

Several countries have already implemented serialisation regulations, with Turkey being the first to do so, and many are in the process of implementing or have implementation timelines in place. Some, such as the United States, are adopting serialisation and aggregation in stages, some have adopted both but others have no plans in place to require aggregation. (see timeline)

To better understand the plans and objectives of the major markets, it’s important to first explore what serialisation and aggregation mean in the different jurisdictions.

From Serialisation to Aggregation

The purpose of both serialisation and aggregation is to ensure all stakeholders have traceability in each step of the supply chain – from manufacturer to wholesalers to hospitals to distributors to importers to pharmacies, all the way to the patient. At its most basic, serialisation refers to the use of serial numbers on the package level using a 2D barcode to uniquely identify a medicine.

Aggregation also uses serial numbers but embedded at the supply level, meaning on the case rather than on individual packages The U.S. has already implemented serialisation and will require aggregation as well by late 2023. The European Union has no plans to mandate aggregation.

While companies are not required to adopt aggregation in the EU, many companies have chosen to do so, because it is far easier to manage and maintain since it enables traceability without having to open cases and packages to verify and check serialisation numbers.

Europe and the US Compared

The two largest markets – the EU and the U.S. – have some overlap in terms of how they are implementing serialisation, but there are also stark differences. These differences are defined under the specific regulations: the Falsified Medicines Directive (FMD) in the EU and the Drug Supply Chain Security Act (DSCSA) in the U.S.

Both jurisdictions require manufacturers to adopt 2D barcode scanning using the GS1 DataMatrix identification system, in which unique data is embedded. This data includes the product code (also referred to as the Global/National Trade Item Number or GTIN in the EU or the National Drug Code or NDC in the U.S), the serial number, the batch number, and the expiry date. The European Commission also requires manufacturers to have anti-tampering devices as proof of authenticity. In Europe, there is also the option to include the national reimbursement number in the barcode.

In the EU, data is stored in the European Hub and managed by the European Medicines Verification Organisation and at the national level by the NMVO (National Medicine Verification Organisation).The NMVO is  linked to the EU Hub, allowing stakeholders to verify medicine authenticity at different steps in the supply chain  . The U.S. uses a global data synchronization network and companies are required to keep a record of transactions. However, verification is only carried out if falsified medicines are suspected, and only at the request of the Food and Drug Administration.

Why Serialisation Matters

Stakeholders must ensure they meet serialisation requirements in each country or their ability to manufacture and sell their products will be put at risk. To meet the various regulatory requirements, such as the FMD and the DSCSA, it’s important to ensure that relevant data and serialisation information are exchanged with all stakeholders in the supply chain, and that reporting requirements are followed according to the regulations.

Serialisation requirements are complex and involve multiple stakeholders, so it’s important to have processes in place, to be prepared for implementation of regulations worldwide, and to carefully manage transition to any serialisation solution.

As a global company with presence in multiple markets, ProductLife Group can support clients with the regulatory intelligence necessary to prepare for and adapt to different regulations worldwide. PLG can also provide project management to coordinate activities across all departments involved — supply, logistics, and regulatory. Our expert regulatory team can also handle all regulatory compliance activities, for example, ensuring packaging requirements are met. And our local teams can manage specific requirements at the affiliate level.

With the recent acquisition of U.S.-based biotech consulting company DSI, PLG is well-placed to support clients to meet evolving DSCSA requirements.

Our experts have extensive experience managing serialisation on behalf of clients. For example, PLG is working with a French biopharmaceutical company to support their overall serialisation program. A PLG regulatory expert works alongside logistics, production, artwork, and marketing to ensure serialisation compliance.

PLG analyses global requirements for the company, works with health authorities and relevant organisations, and collaborates with local partners and affiliates to ensure serialisation requirements are met in every country in which the company is authorised to market its medicine.

The future for serialisation

As more countries adopt serialisation regulations, having streamlined processes and a clear way to manage all relevant metadata, will ensure companies  can easily adapt to new requirements and that quality medicines are securely delivered to patients worldwide.

Written by Emna Clam, Regulatory Information Management consultant at ProductLife Group

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Serialisation: A Global Imperative