ISO updates medication packaging specification

The International Organization for Standardization (ISO) has revised the international technical specification (TS) relating to the barcodes used on medication packaging.

Ensuring the correct identification, labelling and tracking of medicinal products throughout the whole supply chain is essential to help prevent fraudulent pills from entering the market. International machine-readable coding of product packaging is an effective way of achieving that, ISO said.

ISO/TS 16791, 'Health informatics – Requirements for international machine-readable coding of medicinal product package identifiers', provides guidelines on identification and labelling of medicinal products from the point of manufacture of a packaged medicinal product to the point of dispensing the product.

The document sets out everything manufacturers and regulators need to know to implement barcodes on medicinal packaging and is applicable to Automatic Identification and Data Capture (AIDC) technologies. While the technical specification outlines best practice for AIDC barcoding solutions, users can also consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

ISO/TS 16791 complements ISO's series of standards for the Identification of Medicinal Products (IDMP), covering various regulatory requirements such as those related to development, registration and lifecycle management.

Improvements in this latest version include new information such as that related to personalized medicine, explained Christian Hay, Convenor of the working group of experts that developed the specification.

'We have also added examples of IDMP identifiers based on real cases and made changes to align it with other related standards that pertain to the identification of medicinal products.'

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