Serialization is the process of assigning unique identifiers (UIs) to individual saleable units. These identifiers enable tracking and authentication of products throughout the supply chain, ensuring their precise identification.
As a system for tracking and verifying authenticity, serialization provides full control over product flow—from manufacturing to final sale. It increases consumer safety by removing counterfeit or suspicious products from the market. It also simplifies supply chain management and contributes to process optimization, resulting in measurable cost savings.
According to the WHO, up to 1% of medicines sold in developed countries—and as much as 50% of medicines purchased online—may be counterfeit.
In the European Union, Commission Delegated Regulation (EU) 2016/161—known as the Falsified Medicines Directive (FMD)—has been in effect since February 9, 2019. It is based on Directive 2011/62/EU of June 8, 2011, and aims to protect the legal supply chain from the infiltration of falsified medicines. Serialization applies to prescription medicines (with some exceptions), selected OTC products, and also tobacco products.
Tobacco products are also subject to tracking and anti-counterfeiting regulations under the Tobacco Products Directive (TPD, 2014/40/EU). This directive came into force in the EU on May 20, 2016, and requires full traceability of tobacco products throughout the supply chain—from manufacturer to retailer. In addition to improving public health safety, it facilitates the enforcement of taxes and excise duties and helps combat smuggling.
Aggregation allows for faster and more accurate identification of products as they move through the supply chain. It supports compliance with safety requirements by enabling the automatic transfer and enrichment of data between supply chain participants. This allows the entire contents of a bulk package to be identified with a single scan. Aggregation also simplifies product recalls and improves logistics and inventory management in the case of damaged or incomplete packages or pallets.
Pre-implementation audit and assistance in selecting the right system provider
Implementation and validation of serialization and aggregation systems
Knowledge transfer and tailored training sessions
Data migration from legacy or coexisting systems
Ongoing support and further system development
