Brazil

Regulation name

RDC 157/2017, Law 13.410/2016 - National Medicine Control System (SNCM)

Serialization status

In progress but effectively suspended – while a legal basis exists and deadlines were established (30 % by Apr 2022, 100 % by Apr 2024), SNCM rollout has been paused indefinitely after the Senate approved Bill 3846 in April 2022 repealing serialization mandate

Country population

212.6 million

Alert requirement: Currently inactive; part of SNCM (National Medicine Control System). The system generates alerts for suspicious events or data discrepancies

Aggregation requirement: Not yet implemented - planned

Track & Trace requirement: No

Official governing body: ANVISA (Agência Nacional de Vigilância Sanitária - National Health Surveillance Agency)

Serialization type / level:
Originally set April 28, 2022, but dropped after Bill 3846 and currently suspended: GTIN + ANVISA Medicine Registry Number (13-digit) + SN (13-digit) + EXP + LOT

MAH / CMO responsibilities: MAH were required to participate; CMOs could report if delegated—but no active system

Serialized product scope: Not implemented - prescription (Rx), Over-The-Counter (OTC), and imported products

Penalties for non-compliance: None currently enforced

Repackaging rules:
Specific rules apply for repackaging. If a product is repackaged in a way that alters its unique identifier (e.g., new primary packaging or new aggregation layer), it generally requires re-serialization and reporting of the new data and the decommissioning of the old data

Brazil

Alert requirement: Currently inactive; part of SNCM (National Medicine Control System). The system generates alerts for suspicious events or data discrepancies

Aggregation requirement: Not yet implemented - planned

Track & Trace requirement: No

Official governing body: ANVISA (Agência Nacional de Vigilância Sanitária - National Health Surveillance Agency)

Serialization type / level:
Originally set April 28, 2022, but dropped after Bill 3846 and currently suspended: GTIN + ANVISA Medicine Registry Number (13-digit) + SN (13-digit) + EXP + LOT

MAH / CMO responsibilities: MAH were required to participate; CMOs could report if delegated—but no active system

Repackaging rules:
Specific rules apply for repackaging. If a product is repackaged in a way that alters its unique identifier (e.g., new primary packaging or new aggregation layer), it generally requires re-serialization and reporting of the new data and the decommissioning of the old data

Market coding requirements:

Defined in law, not enforced – includes GS1 DataMatrix with GTIN, ANVISA registration number, Serial Number, Batch, Expiry, and SSCC for aggregation

Brazil

Alert requirement: Currently inactive; part of SNCM (National Medicine Control System). The system generates alerts for suspicious events or data discrepancies

Aggregation requirement: Not yet implemented - planned

Track & Trace requirement: No

Official governing body: ANVISA (Agência Nacional de Vigilância Sanitária - National Health Surveillance Agency)

Serialization type / level: Originally set April 28, 2022, but dropped after Bill 3846 and currently suspended: GTIN + ANVISA Medicine Registry Number (13-digit) + SN (13-digit) + EXP + LOT

MAH / CMO responsibilities: MAH were required to participate; CMOs could report if delegated—but no active system

Repackaging rules: Specific rules apply for repackaging. If a product is repackaged in a way that alters its unique identifier (e.g., new primary packaging or new aggregation layer), it generally requires re-serialization and reporting of the new data and the decommissioning of the old data

Market coding requirements:

Defined in law, not enforced – includes GS1 DataMatrix with GTIN, ANVISA registration number, Serial Number, Batch, Expiry, and SSCC for aggregation

Serialization type / level:
Originally set April 28, 2022, but dropped after Bill 3846 and currently suspended: GTIN + ANVISA Medicine Registry Number (13-digit) + SN (13-digit) + EXP + LOT

Repackaging rules:
Specific rules apply for repackaging. If a product is repackaged in a way that alters its unique identifier (e.g., new primary packaging or new aggregation layer), it generally requires re-serialization and reporting of the new data and the decommissioning of the old data