The correct identification, labelling and tracking of medicinal products throughout the whole supply chain is essential to prevent fraudulent pills from sneaking onto the market. International machine-readable coding of product packaging is an effective way of achieving that, and the international technical specification (TS) for it has just been revised.
ISO/TS 16791, Health informatics – Requirements for international machine-readable coding of medicinal product package identifiers, outlines everything manufacturers and regulators need to know to implement barcodes on medicinal packaging and is applicable to Automatic Identification and Data Capture (AIDC) technologies. It complements the ISO series of standards for the Identification of Medicinal Products (IDMP) that covers various regulatory requirements such as those related to development, registration and life-cycle management.
Christian Hay, Convenor of the working group of experts that developed the specification, said improvements to this latest version include new information such as that related to personalized medicine.
“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.”
ISO/TS 16791 was developed by working group WG 6, Pharmacy and medicines business, of technical committee ISO/TC 215, Health informatics, the secretariat of which is held by ANSI, ISO’s member for the USA. It is available from your national ISO member or the ISO Store.