Brazil

v. 15 – Q3 2020

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).

Following completion of the pilot in May 2019 and review of the outcomes, the phased roll-out timetable is now in place:

  • 25% of product data uploaded to SNCM by October 1, 2020 (to be confirmed)
  • 50% of product data uploaded by April 1, 2021
  • 75% of product data uploaded by September 1, 2021
  • All products uploaded by April 1, 2022

Major Developments (September 2020 reviewed): ANVISA Normative Instructions (NI) and Technical Guidance is under formal and legal review. ANVISA do not anticipate any further changes to the documentation. ANVISA publication on updated phased roll-out –first deadline of 25% expected in early October 2020 and the new requirement is to serialise as many products as possible even if the 25% benchmark has not been met. April 2022 deadline WILL NOT change. Deadline for MAH’s to report their serialisation planning to the SNCM dashboard of lines, manufacturing plants, SKU’s, distribution centers.

COVID-19 Update: The formal and legal approval of the Normative Instruction and Technical Guidance could be impacted as the approval of any possible vaccine takes priority.

Key Dates
  • April 1, 2022: Serialization and Aggregation deadline for all products. Detailed requirements to follow.
  • February 28, 2022: Deadline to present Serialisation planning and communication with downstream partners. MAH have been advised to start the implementation of Serialisation in order to meet the April 2022 deadline
  • December 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)
  • 2020: Start of implementation; National System of Drug Control (SNCM) to initiate in 4 stages, with 25% of product data uploaded to SNCM by 1/10/20. 50% of product data uploaded by January 4, 2021. 75% of product data uploaded by January 9, 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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