GTIN Management in Healthcare and Pharmaceuticals

 In Barcode Quality Training

We talk a lot about barcode print quality, but it is equally important to confirm that your GS1 number assignments are correct. The GS1 GTIN Management Standard spells it all out, but it can be confusing. Add to that basic confusion a corporate merger or acquisition and it can be vexing. Let us clear it up.

What is a GTIN

The GTIN identifies any trade item that is priced, ordered or invoiced in an open supply chain. If you operate a closed loop system, you do not need to conform to the GS1 standard. The GTIN uniquely identifies items, which helps to assure their regulatory compliance. A GTIN has two major components. The first component, starting on the left side of the linear barcode or the beginning portion of a 2D symbol is a string of numbers that identify the brand owner. This component includes a GS1 prefix and the company number. It can be from 6 to 10 digits in length, depending upon how many items you will need to uniquely identify.

The entire GTIN is 14 digits long, so depending upon how many digits are in the assigned GS1 prefix and company number, you may have from 3 to 7 digits available to assign uniquely to each of your products. The 14th digit is a mandatory check digit, calculated from the previous 13 digits.

How to Assign Item Numbers

What numbers to assign to your products seems like an important decision. Be careful not to overthink this. Using the numbering system to “classify” your products causes unnecessary complications.  The GTIN is just a dumb number used for database lookup. Spend the time pondering how to avoid accidentally assigning the same number to different products. That beautiful grid of product types and quantities is a futile attempt to predict an unpredictable future. Just roll with it.

Medical Device or Kit

Do not worry about distinguishing your medical devices from kits. The numbers do not do that—the database does. Besides, what you think is a medical device your trading partner might think is a kit. They can call it whatever they want—the good news is they want to buy it.

What happens when your company buys another company who has their own Company Prefix? First, read the fine print in the purchase contract: make sure the seller did not retain these assets. If you are sure you bought them, the next thing to do is to make sure the GS1 licenses are current. Legacy licenses were perpetual; newer licenses renew annually. Check Member Services at your GS1 Member Organization.

Mergers and Acquisitions

Contact GS1 US:

Assigning product identification numbers also requires careful consideration. New products require assignment of a new GTIN. Changes to an existing product can also require assignment of a new GTIN, with a few exceptions:

  • Minor changes to product size or weight
  • Addition of secondary language text (primary language remains the same)

When is a New GTIN Required

Effective December 31, 2018, GTINS from a retired product SHALL NOT be reassigned. Discontinued GTINS should be marked as retired in all databases or removed. Exceptions include:

  • Items that were GTIN identified but never produced and released in the marketplace
  • Items that were withdrawn from the market and then re-introduced without modifications or changes that would require a new GTIN

GTIN assignment and management can be confusing, but the overall logic is as follows: if there is any need to distinguish the item from other items for marketing, tracking , usage or recall purposes, the item must bear a unique GTIN.

A wealth of information on barcode quality and compliance is available here.

Still feeling uncertain? Let us help. Contact us here.




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