The International Coalition of Medicines Regulatory Authorities (ICMRA) has development of a policy paper on national traceability systems for medical products with a strong focus on interoperability. Interoperability is key in the fight against fake medicines as it enables common technical denominators that facilitate the exchange and use the information on medicines and their supply chains among different systems. In ICMRA’s words using track and trace systems “helps to protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities.”
The publication reinforces the use of international standards like GS1, Fight The Fakes Alliance’s member. ICMRA’s key recommendations are the following:
1) Use numeric product identifiers;
2) Enable the use of widely accepted international standards;
3) Use four data elements – unique product code, serial number, expiry date and lot/batch number;
4) Provide clear requirements on packaging level identification;
5) Use ISO/IEC Data Matrix on secondary packaging;
6) The use of scratch-off mechanisms is not recommended as they add costs and don’t increase security;
7) Avoid mandating the use of RFID;
8) Avoid mandating the use of 2D/Matrix bar code other than ISO/IEC Data Matrix on secondary packaging data carriers for product identification;
9) Barcodes do not replace human readable information on the pack; and
10) Use a globally standardised syntax.
