Argentina fleshes out medicine traceability proposals

Argentina has provided some more detail about its proposed traceability systems for medicines, which was laid out in Resolution 435/2011 earlier this year and is designed to tackle the issues of counterfeit, stolen, unlicensed and otherwise illegal medicines.

According to preliminary information on a new website set up to disseminate information on the new system (in Spanish), Argentina plans to require the use of 2D datamatrix codes on secondary medicine packaging including a unique serial number, GS1-standard Global Trade Item Number (GTIN) and - optionally - lot number and expiration dates.

The coding should also appear in human-readable form, according to the proposals, which make it optional (but recommended) to apply codes to tertiary packaging such as pallets, bundles and cases.

Meanwhile, as an interim measure a linear (GS1-128) barcode or RFID carrier can be used to speed up adoption and assist companies which are already using these technologies for unit pack identification.

The phased introduction is anticipated, initially focusing on critical products including cancer drugs, various biologics including interferons and haemophilia treatments, and anti-HIV medicines. The list of critical active pharmaceutical ingredients (APIs) is listed in Annex I of Provision 3683/2011, which was published on May 23.

The timeframe for the roll-out of the system is detailed in Appendix II of the 3683/2011, with an initial six-month setting-up phase from June 15, 2011. Another six months is envisaged to allow validation of the system.