From January 1, 2025, manufacturers and suppliers of regulated healthcare products must adhere to a new requirement for date encoding in barcodes. This means that dates encoded in GS1 barcodes must specify a particular day and cannot use “00” as a placeholder for the day.
Why the change?
The current practice of using “00” as a placeholder for the day in the expiry date of some regulated healthcare products poses a risk to patient safety. “00” is not a valid representation of a day and can cause confusion, errors, and waste.
Examples of problems:
An expiry date such as “2024-12-00” can be interpreted in several ways, such as December 1, December 31 or any other day of the month. This uncertainty can lead to:
- Products used after the expiry date
- Incorrect doses are administered
- Useful products are discarded unnecessarily
How does this affect GS1 standards?
This change affects the GS1 standards used to encode and share product information in the healthcare sector.
GS1 standards include a set of barcodes that can store expiration dates and other attributes of regulated healthcare products. The current GS1 standards that allow “00” as a placeholder for the day in the expiration date will no longer be compatible with the GS1 General Specifications from January 2025.
The GS1 standards have been updated to reflect the new date requirements, and companies manufacturing regulated healthcare products must ensure that production and expiry dates indicate a specific date for the expiry of the product.
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.
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’.
NOTE: 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.
The new date format will improve patient safety by reducing ambiguity and variation in expiry date information. It will also strengthen the traceability and quality control of regulated healthcare products and reduce waste in inventory management.
This change is in line with global trends and expectations for date formats in the health sector and facilitates information exchange and interoperability between different systems and actors.
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