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Change of date format for regulated healthcare products

Forthcoming changes in the pipeline for dates encoded into barcodes.

Pharmacists

From January 2025, manufacturers and suppliers of regulated healthcare products will need to ensure the new date format is encoded onto their product barcodes.

Why the change?

The current practice of using '00' as a placeholder for the day of the month in the expiry date of some regulated healthcare products poses a risk for patient safety. The use of '00' is not a valid representation of a day and can lead to confusion, errors, and waste. For example, a product with an expiry date of 2024-12-00 could be interpreted as expiring on 1 December 2024, 31 December 2024, or any other day in December, depending on the context and the system that reads the date. This could result in patients using expired products, receiving incorrect doses, or discarding usable products.

Impact on GS1 standards

The new date format will impact the GS1 standards that are used to encode and share product information in the healthcare sector.

Person scanning medical device

GS1 standards include a set of barcodes that can store the expiry date and other attributes of the regulated healthcare products. The current GS1 standards that allow the use of '00' as a placeholder for the day of the month in the expiry date field will not be compliant with the GS1 General Specifications from January 2025.

GS1 standards have been updated to reflect the new date requirements, with companies manufacturing regulated healthcare products having to ensure that production and expiry dates identify a specific day for the product's expiration.

The new date requirement in GS1 standards

In GS1 barcodes, dates are encoded using Application Identifiers (AIs), which are numeric prefixes that define the meaning and format of the data elements. For instance, the AI for expiration date is (17), and it follows a standard format with a predefined numerical length.

2D DataMatrix barcode on product

The format of the date field in GS1 barcodes is always YYMMDD. Going forward, the ‘DD’ element of the date will need to be a specific day rather than ‘00’.

N.B. This format specifically applies to the production information encoded in GS1 barcodes, such as GS1 DataMatrix and GS1-128. The format of the human-readable date placed anywhere elsewhere on the label or packaging should be formatted to comply with applicable market regulations e.g. US / China / UK and European formats, or ISO 8601.

What are the benefits?

The new date format will improve patient safety by reducing the ambiguity and variability of the expiry date information. It will also enhance the traceability and quality control of the regulated healthcare products, as well as helping to reduce waste for inventory management purposes.

This change will align with the global trends and expectations for date formatting in the healthcare sector and will facilitate the data exchange and interoperability between different systems and stakeholders.

Help making changes to products

GS1 UK can provide guidance and support for the implementation and transition of the new date format. Details for help and support can be found below.

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