GS1 General Specifications — identification keys, data attributes and barcodes

The foundational GS1 standard defining how identification keys, data attributes and barcodes are constructed and used — GTIN, SSCC, SGTIN, GS1 Application Identifiers, GS1-128 and GS1 DataMatrix. Released annually each January; Release 26.0 was published in January 2026.

LAST REVISED

January 2026

PRODUCT AREAS

DistributionSolid DoseSterileBiotechDevices

SCOPE & APPLICABILITY

Any organisation applying or reading GS1 identifiers — which in practice means every party to a serialised pharmaceutical or device supply chain.

KEY REQUIREMENTS

01Correct construction of identification keys for the product hierarchy in use
02Barcode symbology, dimensions and print quality meeting the specified grade
03Alignment of the release in use with what trading partners are exchanging

IMPLEMENTATION TIPS

›Verify printed symbols to the specified grade as an in-process control, not as a one-off qualification activity

›Review the January release each year for changes affecting allocation rules and Application Identifiers already in use

›Settle GTIN allocation rules with regulatory and commercial before launch — retrofitting a GTIN change across a distributed supply chain is far harder than deciding it once

GS1 General Specifications: frequently asked questions

Quick answers to common questions about GS1 General Specifications.

What is GS1 General Specifications?

GS1 General Specifications — GS1 General Specifications — identification keys, data attributes and barcodes — is a standard issued by the GS1. The foundational GS1 standard defining how identification keys, data attributes and barcodes are constructed and used — GTIN, SSCC, SGTIN, GS1 Application Identifiers, GS1-128 and GS1 DataMatrix. Released annually each January; Release 26.0 was published in January 2026.

Who does GS1 General Specifications apply to?

Any organisation applying or reading GS1 identifiers — which in practice means every party to a serialised pharmaceutical or device supply chain.

What are the key requirements of GS1 General Specifications?

GS1 General Specifications requires, among other things: Correct construction of identification keys for the product hierarchy in use; Barcode symbology, dimensions and print quality meeting the specified grade; Alignment of the release in use with what trading partners are exchanging.

When was GS1 General Specifications last updated?

The current version of GS1 General Specifications dates from January 2026.

RELATED STANDARDS

DSCSA (FD&C Act §§581–585)

Drug Supply Chain Security Act

→

2013/C 343/01

EU Guidelines on Good Distribution Practice of Medicinal Products

→

RELATED FDA RECALLS

where Documentation & Change Control control fails

2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.

See all Documentation & Change Control recalls →

Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.

THIS STANDARD IN PRACTICE

FDA RECALLSWhere this control failsLive recalls SPEQ maps to Documentation & Change Control →MATURITYAssess your quality systemBaseline against this and 9 other GxP domains →FDA QMMQuality management maturityHow FDA rates the system behind this →

Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.

Weekly Briefing

Track the standards that move

When GS1 General Specifications — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.

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