December 18 Update: ANVISA continues to modify its Normative Instruction and certain requirements, deadlines, and terminology may have changed since this article was originally published. Updated information will be published as soon as it becomes available.
On May 14, ANVISA issued Draft Normative Instruction (NI) on the serialization and compliance reporting of pharmaceutical products, based on feedback to the Public Consultation No. 747, which closed in February. According to this latest information, Marketing Authorization Holders (MAHs) and Importers will need to start sending serialized product and transaction data to the SNCM system as soon as December 1, 2020.
With this first deadline less than six months away, your preparations need to start now. Managing serialized product across importation and distribution operations is more complex than expected. Watch this on-demand webinar with TraceLink’s VP of Industry Marketing and Community Brian Daleiden, and Director of Brazil Initiatives Luca Gabrielli, to:
- Get details on the latest NI and technical guidelines from ANVISA, including meetings with industry stakeholders and discussions at ANVISA public meetings.
- Understand what is expected for the December 1, 2020 deadline and how you must prepare based on TraceLink’s deep experience in meeting other serialization and compliance laws.
- Learn about the unique challenges of the horizontal supply chain integration requirement.
- Hear considerations specific to multinational companies selling into Brazil, and their local affiliates.
Don’t miss this opportunity to get expert guidance on ANVISA’s directives and begin finalizing your readiness plan for RDC 319/2019.