NBN EN ISO 16791:2026

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO 16791:2026)

ACTIVE

About this standard

Languages
English and French
Type
NBN
Standards committee
CEN/TC 251 (Health informatics)
Status
ACTIVE
Publication date
01 April 2026
ICS Code
35.240.80 (IT applications in health care technology)
Withdrawn Date
Price
€ 166,00

About this training

Summary

This document provides requirements on identification and labelling of medicinal products from the point of manufacturing of packaged medicinal product to the point of dispensing the product.
This document outlines commonly accepted international practices for automatic identification and data capture (AIDC) barcoding solutions for applications and applies to manufacturers, distributors, healthcare facilities and all parties involved in labelling and distribution of packaged medicinal products. These users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. radio frequency identification (RFID) that technology is not addressed in this document except as for information.