Brazil

v. 22 – Q2 2022

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:

  • Shortly before the original compliance date (28th April 2022) the project was put on hold, following various legal and legislative interventions and the 28th April deadline was revoked.
  • From the 23rd of May 2022, ANVISA suspended their contract with DataPrev (SNCM Developer) for 120 days.
  • Although the SNCM test environment is still available, the production system will no longer be available and supported during his period.
  • Law 14,338/2022 changed the model for drug traceability in Brazil:
    • Some requirements from Law 11,903/2009 were revoked
    • But the new law introduced the requirement for digital leaflets
    • It also confirmed the general intention to introduce a drug supply tracking system, however, details remain to be confirmed
  • Although a physical package insert is required, ANVISA urge MAH’s to introduce a digital leaflet (digital package insert) to medicinal packs.

Excellis Observations and recommendations:

  • We recommend to continue readiness preparations to the previously issued requirements
  • We are working with several customers that are continuing their testing with the SNCM test environment (as this system is operational, but not supported) by uploading reports and reviewing SNCM responses.
  • With regards to uploading digital leaflets, ANVISA have yet to clarify where the digital leaflets are to be stored or if they need to be hosted by the MAH
  • We have seen customers overlook the fact that the Manufacturing Date is a requirement (HRI only, not in 2D DM)
Key Dates
  • September 2017: Pilot starts
  • 2018: Pilot due to complete September 2018; start of implementation (see Note 5)
  • May 2019: Successful completion of pilot
  • October 16, 2020: Draft Normative instructions and technical guidelines published (under legal review and approval); publication of definitive version has been delayed to early 2021)
  • May 23, 2022: ANVISA suspended their contract with DataPrev for 120 days. The SNCM system will remain unsupported during this period

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