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:
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.