The first stage of
Argentina's national medicine traceability initiative is proceeding
in a "very satisfactory manner," according to National
Administration of Drugs, Food and Technology (ANMAT) director
The traceability scheme was mandated in April 2011 by Resolution
435/2011 in order to defend the medicines supply chain from fake,
stolen, unlicensed and otherwise illegal products, with a
subsequent update the following May putting in place a 12-month
deadline for the system, based on the use of serial numbers on
secondary packaging of critical medicines such as cancer and HIV
The first phase of the project began on December 15, according to
press release, with a large number of stakeholders
(manufacturers, distributors, logistics providers and pharmacies)
taking part and more than a million medicine 'transactions'
recorded under the scheme.
Traceability initiatives in the EU, USA and
elsewhere will require pack-level coding (serialization) for
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ANMAT has been running a series of workshops as well as official
visits to regional areas of Argentina in order to advise and assist
stakeholders to come into compliance with the traceability
requirements. So far, the provinces of Chubut, Cordoba, Jujuy,
Mendoza, and Misiones have joined the programme.
A second phase will begin in the summer in which pharmacies and
public hospitals will also accede to the system, completing the
final links in the medicine supply chain. Patients will also be
able to verify the serial numbers on their packs via ANMAT's web
Argentina's Health Minister Juan Manzur said the progress with the
system means that the country is now one of the few around the
world with a specific policy on medicines traceability.