GTIN a potential alternative to the pharmacode and the UDI?

GTIN, the Global Trade Identification Number has attention in the health care industry and is on the rise. Does the GTIN offer a valuable alternative to the Pharmacode and the UDI? Learn here more about the GTIN.

what is the pharmacode?

The Pharmacode is a barcode standard used primarily in the pharmaceutical industry to label and subsequently control the packaging. Sometimes, the Pharmacode is referenced as pharmaceutical binary code and is little prone to printing errors. The code further can be printed in different colors and other than black, sometimes being adjusted to the overall corporate or brand design of the product.

The Pharmacode is a barcode which is binary and differentiates itself from regular barcodes which are decimal, such as a Universal Product Code (UPC). Further, the intent of the Pharmacode is to control the packing and not code for the product or its price.

What is the UDI?

The Unique Device Identifier (UDI) is used for medical devices and not for pharmaceuticals. The UDI is an alphanumeric code and its primary use is to track medical devices over their lifecycle. Special focus lies in the post-market safety-related activities with such products for which the UDI is used to identify clearly the product.

The concept of the UDI has been implemented by the US FDA and will be implemented by the EU with the ratification of the MDR 2017/745 and IVDR 2017/746. The UDI codes for the batch number, a serial number, the expiration date and the manufacturing date of such products.

The UDI has to be registered in the specific database, which is the GUDID in the USA and the EUDAMED in the EU.

what is the GTIN?

The Global Trade Identification Number (GTIN) is used to identify and mark products. GTIN is the identification number used widely in eCommerce and other digital processes in the health care industry. The GTIN is a decimal barcode, which is machine and human readable. In addition to the identification of the product, a GTIN is applied on the packaging at every packing step, e.g. product cardboard box, convenience box, shipment box, and transport box. With this, the packing hierarchy is taken care of as well, which is important in cases of single product or convenience box sales.

Is the GTIN a good replacement?

The GTIN has a slightly different purpose than the Pharmacode and the UDI. However, with the extension to a 2D-GTIN, following the GS1-standard for coding, additional attributes of the product, relevant for Pharma and Medical Devices could be implemented. With a 2D-GTIN, the requirements from Pharma and Medical Devices could be taken care of but would require some efforts to change to this system, which is currently not intended nor under discussion.

Whatsoever, the GTIN is already in use as a secondary identifier in the health care industry. In fact, the GTIN is used as secondary identification in > 80% of the GUDID and Pharmacode databases. This does not come as a surprise as more and more of the supply chain and point of sales of such products are digitized and GTIN is primary used in these environments.

How Avanti Europe can help

Avanti Europe’s Experts have a decade-long track record and expertise in consulting and contracting to the Pharmaceutical and Medical Device industry. Our experts support your company with hands-on workforce and support the notification and data entry into EUDAMED, definition of the QMS, the labeling of the product, processes, the documentation, training for the company staff, and audits for Medical Device QMS,  and Supplier audits. Visit our online shop for checklists and other services.