Brazilian Regulator Anvisa Issues New Track and Trace Guidance

Posted 20 August 2014 | By Louise ZornozaRegLink News

Brazilian Regulator Anvisa Issues New Track and Trace Guidance

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Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM). 

The guidance manual, released 18 August 2014, specifies the requirements for mandatory registration with SNCM, the data that should be made available to Anvisa, and the nature of the communication among participants within the pharmaceutical chain of distribution. The manual also defines which events should be reported to Anvisa.

The manual was the subject of discussion within the Steering Committee for the Implementation of SNCM, which was established by Anvisa to track and monitor the implementation of the national system.  The Steering Committee has representation from 25 governmental agencies and other entities.

 

Anvisa Guidance Manual


Tags: data, Integrity

Categories: Regulatory News

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