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Publication of the new GS1 Healthcare GTIN Allocation Rules Standard

Date: July 16, 2020

Category: Industry news


Since it was first drafted for publication more than a decade ago, the GS1 Healthcare Global Trade Item Number (GTIN) Allocation Rules have been updated and ratified.

We are pleased to announce that Release 10.0 of these rules has now been published. 

The rules are designed to help the industry make consistent decisions about how to manage the unique identification of trade items. To make sure it meets your needs, and is easy to use, the full document has been reviewed by industry peers from across the pharmaceutical and medical device industries based on their own experiences of allocating GTINs to their products.

Here is a summary of the key changes:

  • There is now guidance on a broader range of regulatory healthcare products with specific examples for both pharmaceutical and medical device manufacturers to follow
  • Information for Clinical Trials has been added, explaining the complexities of allocating GTINs to products, referencing the Clinical Trial application standard when identifying products 
  • The standard is now consistent with the GTIN Management standard with the contents table matched for uniformity and cross referencing

This revision serves to provide more content to help understand the requirements of using GS1 standards to uniquely identify your products, and we have also developed a decision support tool to help. The tool will provide information on how to allocate a GTIN, and details scenarios which highlight when, or when not, to issue a new product GTIN. 

We are also running two dedicated training sessions on 4 August and 19 August, which provide a great starting point – register today.

You can also contact a member of the GS1 UK healthcare team at healthcare@gs1uk.org and a member of the team will be in touch to assist with any enquiries.

Further information can also be found in the press release from our global office on our website.