>> TRACEABILITY
In order to assure the control of drugs and to contribute to eradicate the circulation of those that are illegitimate, the Ministry of Health has established a traceability system– through Resolution Nº 435/2011- This system should be implemented by all the people and companies that intervene in the chain of commercialization, distribution and dispensing of pharmaceuticals.
This system consists of the individual and univocal identification of each pharmaceutical unit to be commercialized, in order to execute its monitoring through all the distribution chain (laboratories, distributors, logistic operators, pharmaceutical wholesalers, pharmacies, welfare establishments and patients). So as to guarantee the control of drugs and to contribute to eradicate the circulation of those that are illegitimate.
The Ministerial Resolution prescribes that the National Administration is the authority in charge of putting the system into practice and laying down regulations that are necessary for its implementation. Therefore, the ANMAT [National Management of Medicine, Food and Medical Technology] issued Resolution Nº 3683/2011 that establishes the requirements for the natural or legal person who intervenes in the chain of commercialization, distribution and dispensing of pharmaceuticals registered before this body. Thus, the products information will be part of a database that will replace the current perforated tear-off stub.
The regulation lays down that the Traceability system will be implemented gradually; according to the degree of criticality of the different categories of drugs. First of all, it will be applied on those pharmaceutical units that contain in their composition the Active Pharmaceutical Ingredients (API) [Ingredientes Farmacéuticos Activos (IFA’s)] that are included in Attachment I to the Resolution–either as monodrug or in association of others-, in the pharmaceutical forms established. In Attachment II to the resolution, on the other hand, it is established the schedule for the implementation of the system.
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