Argentina extends medicine traceability initiative

The government of Argentina has announced a major extension to the scope of its medicines traceability project, boosting the number of products covered by the initiative from 350 to around 2,300.

The traceability scheme was introduced last year and involved placing unique serial numbers and tamper-evident features on the secondary packaging of critical medicines, such as cancer and HIV drugs, in order to defend the supply chain from fake, stolen, unlicensed and otherwise illegal products.

On March 28, the National Administration of Drugs, Food and Technology (ANMAT) published a new order (No. 1831) in the Official Gazette adding a raft of new drug classes to the scheme, including antibiotics, insulin, clotting factors and a broad range of cardiovascular drugs and central nervous system treatments including antidepressants, antipsychotics and drugs for epilepsy and Parkinson's disease.

"It is essential to continue the process begun under the implementation of the National Traceability System established by [Resolution 435/11]" which officially comes into force next month, says the order.

An appendix lists all the active pharmaceutical ingredients covered by the new decree, and the expansion will lead to more than 100 million units of medicine being tracked every year under the system, according to the agency.

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ANMAT director Carlos Chiale said in a press statement (in Spanish) that the serial number would allow the medicine to be traced "from manufacturer  to patient", and could be applied to the product via a linear bar code, 2D datamatrix or radiofrequency identification (RFID) tag, at the discretion of the manufacturer.

Moreover, the scheme "also incorporates a security system that ensures the inviolability of packaging and that the contents have not been adulterated," added Chiale.

The new initiative "positions Argentina as one of the world leaders in traceability, even above the EU countries and US," according to ANMAT.