On 28 December 2016, the Brazilian President signed the law 13.410, amending the law 11.903 from 2009. The law was published in the Official Gazette on 29 December 2016 and enters into force as of date of publication. No official English translation is available yet.
ANVISA will define the scope of the medicines covered under the law.
The DataMatrix must be encoded with the following four data elements: ANVISA registration number, Serial number, Lot number, Expiry date. Other data (e.g. GTIN) besides the above four data elements may be included based on ANVISA rules.
A centralized reporting system held by ANVISA will be established for the storage and analysis of the information relating to the medicines covered. Each supply chain player must capture and communicate the required regulatory information to the governmental system.
ANVISA has up to four months to complete regulatory rules for the operational aspects of the system. This period may be extended for justified reasons. For that purpose, ANVISA is planning a public consultation in Q1 2017. A few request for clarifications have been identified and will be raised by stakeholders.
The 3-phase implementation schedule is confirmed:
- 1 year pilot (seems that ANVISA will select pilot participants) of at least 3 batches of product
- 8 month analysis of pilot results
- 3 years for full implementation