Brazil

v. 19 – Q3 2021

Market Executive Summary Brazil is implementing a full Track & Trace approach based on centralised Government DB: National System of Control of Medications – SNCM (Sistema Nacional de Controle de Medicamentos), led by National Health Surveillance Agency (ANVISA) but including data exchanges between supply chain partners (in addition to reporting to the central Gvt. DB).

Major Developments:

  • Normative Instructions published (Aug 2021) setting mandatory implementation date 28th April 2022 for all medicines
  • This means that the previous approach – phased roll-out – has been abandoned
  • MAHs are required to report their serialisation statistics (lines, manufacturing plants, SKU’s, distribution centre etc. ) and planning / preparation status to the SNCM though the dashboard is currently not yet available (see further guidance at https://planos-sncm-stage.gaesi.eng.br/)
  • SNCM technical documents and implementation guidelines have been updated where relevant.
  • Further guidance on horizontal integration is still outstanding
Key Dates
  • April 28, 2022: Mandatory compliance date for all medicines in scope
  • Q3 2021: Reporting of preparedness (thought portal not yet available)
  • Q1 2021 (pending): Further guidance on horizontal integration to be published by working party (see Note 10)
  • December 31, 2020: MAH’s to submit Serialisation planning via the SNCM dashboard including products, lines, plants, and distributors. If MAH’s are currently Serialising and Aggregating products, they DO NOT need to submit their implementation plan (providing they are able to generate vertical and horizontal metadata).
  • October 16, 2020: Draft Normative instructions and technical guidelines published (under legal review and approval); publication of final version has been delayed to early 2021)
  • May 2019: Successful completion of pilot
  • 2018: Pilot due to complete September 2018; start of implementation (see Note 5)
  • September 2017: Pilot starts

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