The EU is a critical player on the global scale in many ways. Economically, it is the third largest market in the world. To protect its consumers and fight counterfeit products, the European Commission has initiated Serialization and Track & Trace regulations for two industries: tobacco and pharmaceuticals. The main technical characteristic for both industries is the unique identifier (UI), which provides the possibility of verifying the authenticity of single folding boxes or cigarette packs. This unique identifier typically contains the GTIN, Serial Number (for pharma Batch Number and Expiry Date are added) in a Data Matrix code. With the introduction of a Digital Product Passport and other green initiatives, the number of industries engaged in Serialization and Track & Trace will continue to grow in the next decade.
The US is the biggest and most competitive market in the world. Serialization and Track & Trace requirements were introduced almost a decade ago and have played a critical role in the pharmaceutical supply chain practices in the USA. These regulations affect prescription drugs, over-the-counter medications, medical devices, and biological products, including those that are manufactured in the US or imported from other countries. The US FDA has set specific deadlines for compliance, and failure to meet these requirements may result in penalties or legal consequences. The original FDA approach to Serialization and Track & Trace forces pharmaceutical companies to collaborate and involve supply chain partners in creating sustainable systems. The latest DSCSA regulation is a good example of that approach.
Brazil is an example of where Serialization and Track & Trace regulations have been postponed several times due to the inconsistency of the dialogue between the government and businesses. The first drafts of legal acts obliging the serialization of pharmaceutical products appeared in Brazil in 2019. The Serialized Drug Traceability program captures the activities from the manufacturing or import of drugs through the distribution of the drugs in the downstream supply chain until they reach the point of dispensing or supply to establishments authorized by the Brazilian Health Regulatory Agency (ANVISA), such as medical institutes and research labs. To achieve serialized drug traceability, a national-level reporting system called "SNCM" has been formed. Nevertheless, the regulations have not been implemented yet.
Uzbekistan is an important player in the CIS market. Serialization is an international project that has been implemented on the territory of the Eurasian Economic Union (EAEU), with best practices mostly taken from the Russian market. The main goal of this project is to decrease the share of counterfeit products. In less than two years, data matrix labeling of tobacco products, beer, alcohol, household appliances, and pharmaceutical products has been launched in Uzbekistan. The CRPT-Turon organization with ASL Belgisi national traceability system declares that Serialization is not only an effective tool to combat illegal imports and sales of low-quality products but also an important source of analytical information.
The Republic of Kazakhstan is one of the largest economies in the CIS. Serialization is an international project that has been implemented on the territory of the Eurasian Economic Union (EAEU), with best practices mainly taken from the Russian market. The main goal of this project is to decrease the share of counterfeit products in the light industry market of Kazakhstan, which currently accounts for 63% of the total turnover, as well as in the footwear market (48.5%), alcohol market (25%), and pharmaceutical market (12%).
Serialization has already begun with long-term experiments for pharmaceutical products and bottled water.
Russia plays a major role in the CIS market. Its market is the most regulated and complicated in the context of Serialization and Track & Trace. The national traceability system, Chestniy ZNAK, controls the turnover of furs, tobacco, pharmaceuticals, milk products, bottled water, apparel, shoes, perfume, digital cameras, and tires. The list of product categories involved is continuously expanding, and final regulation acts are usually issued after completion of the pilot project for a new product group. The emission of serialization codes is provided by the CRPT operator on a paid basis and includes the generation of a verification code that is part of the DataMatrix. All supply chain members from the manufacturer or importer to retail are involved and must register in the Chestniy ZNAK system. The system also provides consumers with the ability to check the authenticity of products by scanning codes in a mobile application.
The Kindom of Bahrain, with its well-developed economy and strong focus on the healthcare industry, has recognized the importance of Serialization and Track & Trace systems in ensuring patient safety and enhancing the efficiency of the supply chain. Traceability was first initiated for pharmaceutical products in 2017 by Legislative Decree No. 41. The track & trace regulation of the Kingdom of Bahrain closely follows those of other countries and is based on GS1 standards. Following the implementation of mandatory serialization for MAH/CMO invoicing, companies are required to report all traceability events (commissioning, shipment/receiving, dispensing and aggregation) to the NHRA-MVC Traceability Hub.
The UNITED ARAB EMIRATES imports the majority of pharmaceutical products and many other product groups. This, along with the country's important role in the world economy, has led to the introduction of Serialization and Track & Trace requirements in the UAE. The country is following the world's best practices, with a traceability decree that applies to all conventional medicines being announced in the UAE in June 2021.
After a transitional period intended for the implementation of serialization, all operations must be reported to the Tatmeen traceability system by code owners. Distributors, dispensing centers, and medical centers report appropriate shipping events of drugs.
The Saudi Arabian economy heavily relies on imported pharmaceutical goods, but the government is actively diversifying the economy and investing in healthcare. The Serialization and Track & Trace regulations introduced in Saudi Arabia closely follow those of other countries and are based on GS1 standards. This standardization is intended to make it easier for global pharmaceutical manufacturers to comply with regulations in multiple countries and help to prevent counterfeit products from entering the global market. All products must be serialized in compliance with the Saudi Food and Drug Authority (SFDA) regulations. Stakeholders must report serial numbers (SNs) through the new authority platform called DTTS (Drug Track & Trace System), which was launched on January 7, 2019.