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Authorities in Brazil Discuss Postponement of Track&Trace Implementation

On May 6, Bill 276/2015 (Original in brazilian Portuguese) was submitted to the Federal Senate of Brazil that intends to postpone the implementation of the traceability system in Brazil. The bill proposes a staged implementation throughout 10 years counting from January 2015:

  • Until Jan. 2019: Requirement to serialize all products both locally produced and imported,
  • Until Jan. 2022: Establish drug chain communication system for transmission of data for the National Drug Control System,
  • Until Jan. 2025: Establish consultation mechanism for data access of ANVISA

In its newsletter dated 13 May, Interfarma, the association of the research-based pharmaceutical industry, has re-iterated that it is “in favor of the traceability, because it is an important step towards a more ethical market with a better protection to patients and fairer competition conditions”. Interfarma has offered to support a postponement in view of the “delay of other sectors of the industry and the difficulties of other segments, such as the public sector, distribution, and retailers” to implement the Track&Trace regulation in Brazil along the current timeline. It suggests a revision of the the existing deadlines that would result in the need “to present the first lots only in 2016 or 2017 and the final deadline would be 2018”. The association has emphasized the goal to implement traceability in the shortest possible time frame and therefore has refused to support the request of the other sectors of the pharmaceutical chain to get a 10-year postponement.

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