The Official Suspension of the Three-Lot Pilot in Brazil

On October 23, 2015, a very brief resolution was published in the Official Diary of the Union (Diário Oficial da União) (Brazil’s equivalent to the U.S. Federal Register) which formally suspends the 3-lot track and trace pilot that drug registration-holders were formerly required to complete by December 10 of this year (see “Brazil Suspends Pharma

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2 thoughts on “The Official Suspension of the Three-Lot Pilot in Brazil”

  1. Dear Dirk,

    Thanks for your great articles about traceability.
    The new reconsideration of the entire tracing model will be done in the law. Anvisa can´t do it before law be approved by Govern since the model was defined by law. The new law include this changing as well new deadlines. It is already done and ready to be voted. A long way must be followed before be applied. The first vote is expected for next days. See the link below although in Portuguese.


    1. Alexandre,
      Thanks for providing that link to the proposed legislation. Once translated, it is a little difficult to follow, except I could see the new requirements that establish a central database managed by the Government and the clear delineation of who owns the data and that the data must be kept confidential. All good things. I hope this bill makes it through the enactment process. Please keep us informed of its progress.


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