As predicted by Pharmabiz, Argentina’s regulator ANMAT has introduced new rules for drugs traceability.
Ruling number 10564, published in Argentina’s governmental bulletin, merges previous lists of active ingredients that must be traced, and adds more.
The measure updates lists published in 2011, eliminating close to 100 drugs listed in four rulings emitted during the presidency of Cristina Fernández de Kirchner and consolidating the remaining 298 complex active ingredients in a single list of drugs that must be tracked under the new National Traceability System. See ruling
At the same time, an appendix lists almost 100 new, latest generation drugs to be added to the regime, mainly ingredients that have been approved by ANMAT since 2011, including several biologicals. These ingredients must enter the traceability system within a period of four months.
They include brentuximab (the brand Adcetris belonging to Takeda); riociguat (Bayer’s Adempas); macitentan (Opsumit from Biotoscana, originally from Actelion) and emtricitabina (Remivir from Elea).