Regulatory Requirements

Regulatory
Requirements

Coding regulations for pharmaceuticals

Coding regulations for pharmaceuticals
Due to the increasing number of counterfeit medicines and unauthorized supply chains, most countries – both industrialized and emerging markets – have already implemented serialization regulations for pharmaceuticals in order to protect patient safety, or are planning to do so.

This section gives an overview* of the global coding requirements related to serialization regulations.

Serialization

In the context of the pharmaceutical supply chain, serialization refers to the assignment of a unique, random serial number to each saleable unit, conferring it with a distinctive identity that allows it to be effectively tracked at virtually at any point during its life cycle.

Aggregation

Aggregation refers to the grouping of individually serialized packaging into larger units such as bundles, cases or pallets. These units bear a code that contains information about the serialized packaging within the unit.

UDI 2D Data Matrix Barcodes and Government Requirements

Since 2013, the U.S. Food and Drug Administration (FDA) has moved toward implementing unique device identification (UDI) systems. In recent years, the requirements for these systems have only grown. The final ruling by the FDA requires device labelers to include the UDI on device labels and packages.

WHAT ARE UDI 2D DATA MATRIX BARCODES?

UDI 2D data matrix barcodes are two-dimensional barcodes that contain vital information about medical devices or pharmaceutical products. Some examples of this information would be the unique identifier (UID) number, lot number, and expiration date.

These barcodes are designed to be small in size yet capable of storing large amounts of data, making them highly efficient for product identification and traceability. Each UDI 2D data matrix barcode consists of a series of black and white squares arranged in a square or rectangular pattern.

IMPORTANCE WITHIN THE MEDICAL DEVICE LANDSCAPE:

Enhanced Product Authentication: UDI 2D data matrix barcodes provide a reliable means of authenticating and verifying medical devices throughout the supply chain. Stakeholders can quickly scan the barcode to confirm a device’s authenticity and integrity, mitigating the risks of counterfeit products.
Efficient Track and Trace: These barcodes enable accurate tracking and tracing of medical devices from manufacturing facilities to end-users. This level of visibility enhances the supply chain, facilitating efficient recalls, targeted investigations, and improved patient safety.
Streamlined Adverse Event Reporting: The use of UDI 2D data matrix barcodes facilitates the accurate reporting of adverse events associated with specific medical devices. The encoded information aids regulatory authorities and manufacturers in promptly identifying and resolving potential safety issues.

GOVERNMENT REQUIREMENTS:

To ensure the widespread implementation of UDI 2D data matrix barcodes in the medical sector, governments worldwide have introduced regulations and requirements. Let’s explore some notable requirements in this field:

U.S. Food and Drug Administration (FDA):
- The FDA mandates the use of UDI 2D data matrix barcodes for most medical devices and pharmaceutical products.
- The UDI must be directly marked on the device packaging or label using automatic identification and data capture (AIDC) technology.
- Compliance timelines and requirements may vary depending on the product classification.
European Medicines Agency (EMA):
- The EMA has introduced regulations under the Falsified Medicines Directive (FMD) that require the use of 2D barcodes on pharmaceutical packaging.
- The barcode must include product identification, serialization, and other necessary information.
- The barcode is verified at various stages of the supply chain to ensure product integrity.
Other Regulatory Bodies:
- Many other countries, including China, Brazil, and South Korea, have implemented, or, are in the process of implementing UDI regulations specific to their medical industries. These regulations typically include requirements for UDI 2D data matrix barcodes on product packaging, labeling, and documentation.

UDI 2D data matrix barcodes have become indispensable tools in the medical device manufacturing environment. They provide unparalleled benefits in terms of product authentication, supply chain visibility, and adverse event reporting. Compliance with government requirements is crucial to ensure the successful implementation of these barcodes. By leveraging UDI 2D data matrix barcodes, the medical device industry can enhance patient safety, streamline recalls, and combat the proliferation of counterfeit products.