v. 3.0 – 10/02/17

Serialization Model Track and Trace
Governing Body ANVISA
Compliance Date
  • On or before 29 December 2017 – Pilot Implementation (3 Lots)
  • Up to 8 months for ANVISA to review Pilot Implementation
  • On or before 29 August 2020 – Based on the completion of the Pilot and 8-month Pilot Review
Randomization Requirements Not Specified
Aggregation Requirements Implied – The requirement (Article 4A – Paragraph 1: Law 13.410) for all Supply Chain participants to transmit all records to ANVISA Repository implies aggregation
Reporting Requirements Product movements uploaded to National Medication Control System
Data Repositories
  • ANVISA Central Repository – National Medication Control System
  • Technical Details for Evaluation Phase (RDC 157 & Normative Instruction No.

    • Additional details to be released
Saleable Unit Data Carrier Implied; GS1 Data Matrix encoded with GTIN, ANVISA Drug Number, Serial Number, Expiry Date, and Lot–in that order
Saleable Unit HRI GTIN, ANVISA Drug Number, Serial Number,
Expiry, and Lot–in that order
Shipping Case Data Carrier GS1 DataMatrix encoded with GTIN, ANVISA Drug NUmber, Serial Number, Expiry Date,
and Lot in that order (additional guidance forthcoming)
Shipping Case HRI Not Specified; Best Practice implied – GS1 Data Matrix or GS1-128 encoded with GTIN, ANVISA Drug Number, Serial Number, Expiry Date, and Lot
Logistics Unit Data Carrier Not specified; SSCC (GS1-128) implied
Additional Notes
  • On 28 December 2016, the Brazilian President signed the Law 13.410 amending Law 11.903 from 2009. On 29 December 2016, Law 13.410 was published to the official Gazette (translatedPress Release); RDC 157 published on 11 May 2017
  • Information systems to be issued within 4 months of Law Publication. Time period may be extended
  • RDC 157 requires maintaining data for supply chain data for one (1) year beyond product expiration.
  • EHS recommends the use of 5 data elements: GTIN + (713) The ANVISA drug number, Serial Number, Expiry, and Lot