Brazil

v. 20 – Q4 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:

  • April 28, 2022 Deadline – legal challenge ongoing but assume DEADLINE IS TO REMAIN
  • No mandatory submission of a serialisation/implementation plan
  • MAHs are urged to provide and maintain 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
  • Horizontal Integration is to be used where it supports and acts as a predecessor to vertical reporting
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)
  • MAH’s to maintain a Serialization Project Plan via the SNMC planning portal (when available). The previous deadline of 31 December submission has been revoked (Normative Instructions 100 25/11/21)
  • 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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