ANVISA

Regulatory Agency

Anvisa

Regulation Name

• Lei nº 11.903/2009 – Establishes the “Sistema Nacional de Controle de Medicamentos (SNCM)”
• Lei nº 13.410/2016 – Amends Law 11.903/2009
• Resolução nº 157/2017, amended by RDC 319/2019 – Standards and procedures for the SNCM
• Instrução normativa nº 19/2017 – Basic technology standards

Timeline of the regulation (Founding dates, compliance dates, etc.)

  • December 2016  – Traceability law is published (Lei no 13.410/2016)
  • April 2017  – RDC 157/2017 is published
  • April 2019  – Anvisa’s pilot ends
  • November 2019  – RDC 319/2019 is published
  • April 2022  – Serialization and aggregation implemented for all prescription drugs

Requirements

• GTIN
• Anvisa registration number
• Serial code
• Expiration date
• Batch number

General explanation

In Brazil, the current law requires the pharmaceutical industry to implement traceability for all its prescription drugs by April 2022. All supply chain stakeholders (industry, distributors and pharmacies) must be connected to Anvisa’s central database called the “Sistema Nacional de Controle de Medicamentos (SNCM)” to track each unit’s status.

The implementation of traceability occurs through the serialization and aggregation of the products. To serialize the cartons according to Anvisa requirements, it is necessary to have a 2D code (Data Matrix) that contains five mandatory pieces of information: GTIN, Anvisa registration number, serial code, expiration date and batch number.

In addition to the 2D code, this information must also be printed on the carton in human-readable format. Although the manufacturing date is not required by the traceability legislation, it is a requirement of RDC 71; some companies therefore choose to include this data. Example: