Argentinian Government Pushes Pharmaceutical Traceability

April 25, 2012

Argentina’s medical traceability project has just been extended, enhancing the number of products covered from 350 to around 2,300. Their initiative, started last year, 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. The National Administration of Drugs, Food, and Technology (ANMAT) published a new order (#1831) in the Official Gazette on March 28th. This order adds a slew of new drug classes, 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.

An appendix also lists all active pharmaceutical ingredients covered by the new plan. This will lead to more than 100 million units of medicines being tracked every year. “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.

In a recent press statement, Mr. Carlos Chiale (the Director of ANMAT) said the initiative will allow the medicine to be traced “from manufacturer to patient” and “also incorporates a security system that ensures the inviolability of packaging and that the contents have not been adulterated.” According to ANMAT, the new initiative “positions Argentina as one of the world leaders in traceability, even above the EU countries and US.”

Read More: Securing Pharma