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National Medicines Traceability System

With the purpose of ensuring the control of medicines and contributing to eradicating the flow of illegal medicines, the Ministry of Health established, under the provisions of Resolution 435/2011 a Traceability System, that is to be implemented by all the persons and companies involved in drug products marketing, distribution and dispensation chains. This system consists of the individual and unambiguous identification of each unit of drug product to be marketed, in order to trace it all along the distribution chain (pharmaceutical companies, logistic operators, drug wholesalers, pharmacies, healthcare institutions and patients). All this aims to ensuring the control on medicines and contributing to eradicating the flow of illegal medicines. The above mentioned resolution establishes that this National Administration is the authority concerned with the system application and, therefore, issuing the necessary regulations for its implementation. Hence, ANMAT issued Regulation 3683/2011, which sets forth the requirements for physical or legal persons involved in the marketing, distribution and dispensation chain of the drug products registered before this agency. Therefore, product information will be included in a data base that will replace the current tagging system. The above mentioned resolution sets forth that the Traceability System will be gradually implemented on the basis of the criticality of the different categories of drug products. Firstly, the new system will be applied to those medicines containing Active Pharmaceutical Ingredients (APIs) included in Annex I of the regulation (either as monodrugs or in association with others) in the established dosage forms. The schedule for the system implementation is laid down in Annex II of the resolution.


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