According to the announcement by the National Healthcare Monitoring Authority (ANVISA), Brazil has a period of three years to adapt to the new system of medication traceability based on Law Nº 11.903/2009-.
The code that will accompany the packaging will have four main pieces of information: the identification number provided by ANVISA, the expiry date and the lot and series numbers that identify each individual package.
The modification includes the use of a Single Medication Identification Code (IUM) made up of an individual, non-repeating number of 13 digits, which shall be placed on the package, coded by Datamatrix and also expressed in legible numeric characters. The IUM will be generated and managed by ANVISA.
Mario Abitbol, leader of Health Development at GS1 Argentina said: “The new traceability system will improve the transparency of the entire supply chain.”
According to the regulations, packages must have a two-dimensional code and the industry will have to obtain an electronic system that works in parallel with the monitoring logistics. ANVISA explained that the monitoring system will make it possible to find out who bought a determined product.
The agency also set a period of two years from the approval of the system for each pharmaceutical company to present a complete traceability report. The Brazilian industry thus asked the regulatory agency to add the DTIN of GS1 standards to ensure the compatibility and interoperability of systems and suppliers.
“Argentina, Turkey, United States, Brazil and everywhere where traceability systems are being implemented are taking a step forward in the struggle against the sale of illegal medications,” said Abitbol.
Furthermore, the leader of Health Development stated that the measure will achieve greater visibility for all medications sold.
Sources: ANVISA and Mario Abitbol
