T&T glossary

The responsibility of T&T often begins with manufacturers and/or importers as they initiate product serialization. However, the responsibility doesn't end there. Third- party logistics providers (3PLs), distributors, and even retailers play pivotal roles in maintaining this traceability. Their collective eff orts ensure a seamless and end- to- end traceability matrix that benefi ts everyone in the supply chain.

Operator: The entity or organization that manages the day-to-day operations of the track and trace system. This could involve managing the IT infrastructure, ensuring data integrity, handling queries from stakeholders, and more.

Controlling Authority: This refers to the governmental or regulatory body that oversees and regulates the track & trace system's operations. The controlling authority sets the standards and guidelines for the system, ensures compliance from all stakeholders, and may levy penalties for non-compliance. They also coordinate with other national and international entities to ensure system effectiveness.

In essence, the "National Track & Trace system operator and controlling authority" ensures that a country's track and trace system operates effectively, transparently, and in line with national regulations and objectives.

Here are some examples of operators and authorities: FDA (USA), SFDA (Saudi Arabia), CRPT (operator of Russian national traceability system), etc.

In the context of traceability, supply chain members are the various entities or stakeholders involved in the production, distribution, and consumption of a product. These members play a crucial role in ensuring that each step of the product's journey is tracked and recorded to maintain its traceability. Here are some typical supply chain members involved in traceability:

Manufacturers: Companies or organizations responsible for producing the product. They are usually the initiators of the traceability process, assigning unique identifiers (such as serial numbers or barcodes) to each item produced.

Suppliers: Entities that provide raw materials, components, or parts used in the manufacturing process. Their inputs are traced through the supply chain to maintain quality and authenticity.

Distributors/Wholesalers: These are intermediaries that transport and store products before reaching the retailers or end consumers. They play a role in tracking the movement of products through the supply chain.

Retailers: Companies that sell the products directly to consumers or end-users. They may also participate in traceability by recording sales and distribution information.

Regulatory Authorities: Government agencies responsible for overseeing and enforcing regulations related to product traceability and safety. They may require the involvement of supply chain members to comply with traceability standards.

Logistics and Transportation Providers: Companies that handle the transportation and delivery of products within the supply chain. They contribute to the traceability by providing data on the movement of goods.

Consumers: The end-users of the products. In some traceability systems, consumers can also participate by scanning QR codes or using other technologies to access information about the product's origin and journey.

Technology Providers: Companies that develop and provide traceability solutions, such as track and trace software, barcode scanners, RFID systems, and other technologies used to capture and manage traceability data.

By involving all these supply chain members and implementing traceability systems, companies can achieve better transparency, ensure product authenticity, improve quality control, and efficiently manage recalls or product investigations in case of any issues.

Marketing Authorisation Holder is the company or legal entity that holds the authorization granted by healthcare authorities to market a medicine. The MAH is responsible for ensuring that the medicine meets the necessary quality, safety, and effi cacy standards, and they are accountable for its distribution, promotion, and post- market
surveillance. In some regions, the MAH is also referred to as License Holder.

Contracted Manufacturing Organisation is a manufacturing entity that produces pharmaceutical products on behalf of the MAH.

The Third Party Logistics refers to a service provider that specializes in outsourced logistics services. These entities:

• Might be established outside of a specifi c country or within special economic zones or free trade areas.
• Often deal with the storage, handling, and transportation of products on behalf of other businesses.
• Are commonly registered with global standard bodies like GS1.

Much like a distributor, a 3PL often manages imported products right before they undergo customs clearance, with their specifi c roles infl uenced by the agreed- upon delivery Incoterms.

GS1 is a global standards organization that develops and maintains standards for supply chain and product identification. For track and trace, GS1's standards provide a consistent framework for capturing and sharing product information throughout the supply chain, ensuring product authenticity, traceability, and efficient inventory management. This is often achieved through the use of barcodes, DataMatrix, Electronic Product Code (EPC), and the Global Trade Item Number (GTIN) system.

Reference data about the static aspects of the business, such as products, suppliers, customers, and locations. In T&T, it's essential that master data is accurate and up- to- date to ensure the traceability data generated is reliable.

Information about changes of state or other signifi cant events in the lifecycle of a product, such as its production, shipment, receipt, etc. In Track & Trace, event data is collected and managed to provide visibility into the movement and status of items as they progress through the supply chain.

Unique Identifi er: A generic term for an identifi er that is globally unique. In the context of Track & Trace, a UID often refers to a serialized number applied to an item or unit for the purpose of uniquely identifying that item or unit.

Serial Shipping Container Code can be used by companies to identify a logistic unit, which can be any combination of trade items packaged together for storage and/ or transport purposes, for example a case, pallet or parcel.

Serial Shipping Container Code can be used by companies to identify a logistic unit, which can be any combination of trade items packaged together for storage and/ or transport purposes, for example a case, pallet or parcel.

Global Location Number (GLN) can be used by companies to identify their locations, giving them complete flexibility to identify any type or level of location required.

GS1 Company Prefixes are based on the GS1 Prefixes below. Since GS1 user companies can manufacture products anywhere in the world, GS1 Prefixes do not identify the country of origin for a given product.

EPCIS (Electronic Product Code Information Services) is a GS1 standard that provides a framework for sharing information about the movement and status of goods in the supply chain. It captures and communicates detailed event data, enabling businesses to have visibility into their products' lifecycle, from manufacturing to point-of-sale or disposal.EPCIS files are structured data files that record these detailed event data. They encompass information such as where an item has been, when it was there, and its current state. These files serve as a standardized means for different systems to exchange and interpret traceability data consistently across the supply chain.