v. 28 – Q4 2023
v.28 Q4 2023 update: Serialisation / Traceability project still on hold; focus now on provision of
e-PIL
| 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). However, since the contact suspension with DataPrev ended, no further developments have been made on the drug traceability in Brazil. The focus for ANVISA has now shifted in introducing a digital e-Leaflet.
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2022) the project was put on hold, following various legal and legislative interventions and the 28th April deadline was revoked.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 May 23, 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.
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| Key Dates |
- 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 2022: Law 14338 (digital package leaflet law) introduced.
- November 2022: ANVISA published ordinance NO 1. 063 to create working group that discusses the e-Leaflet in Brazil
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