Barcoding guideline for prescription drugs voluntary from 2015. Mandatory in 2021 (see key dates in 2) Requirements Phasing)

The new amended of Pharmaceuticals and Medical Devices act makes barcoding compulsory on the packages of Prescription Drugs and Medical Devices for securing traceability.

Implementation of ePI (electronic Package Inserts) for Med. Devices and Prescription Drugs must be provided. Type of barcode on the package to use for this purpose is still open, but Ministry of Health seems to prefer use of QR code.

GS1 is requesting industry support to suggest use of DataMatrix and use of Data Link.

To date, there is not reference to the use of a serial component in the label coding.

• December 1, 2022: Barcode labelling/traceability
• August 1, 2021: Electronic insert
• March 31, 2021: enforcement date for Revised Implementation Guideline for Bar Code Labeling of Prescription Drugs
• August 31, 2016: revision of guideline
• 2012: revision of guideline
• 2006: issuance of guideline