Brazil’s legislation has had a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve complete compliance. Back in 2016, ANVISA signed the National Medicine Control System SNCM into law (Law No. 13.410). It establishes the serialization requirements and timelines for the entire Brazil pharmaceutical supply chain. Post the pilot phase in 2017-2018, the Brazilian industry has grown and matured which has also impacted the legislation. This is why it’s best to start preparing for serialization in Brazil as early as possible. The Brazilian Health Regulatory Agency (ANVISA) is planning on implementing a thorough nationwide serialization solution and it’s regulations are planned to go into effect in May 2022. The SNCM’s set regulations must be followed by all pharma companies that are manufacturing or even importing goods to Brazil.

 With more upcoming deadlines in 2021 and 2022, it’s best to start preparing for Brazil’s serialization as early as possible.

As of now, the ANVISA set upcoming deadlines are:

2021 Deadlines

  • April 2021 – Serialize 50% products
    Pharmaceutical companies and stakeholders have to serialize 50% of their products
  • September 2021 – Serialize 75% products
    By this time, Pharmaceutical companies and stakeholders need to make sure that they serialize 75% of their products

2022 Deadline

  • April 2022 – Serialize 100% products
    Pharmaceutical companies and stakeholders have to serialize all, a 100% of their products 

 The timelines as per the law**, requires a three stage completion:

  1. Up to one year.
    The competent federal health surveillance agency chosen industry, importers and distribution and retail representatives can, on a trial basis, receive and transmit data referring to a minimum of three batches of drugs that contain the information provided for in items I, II, III and IV of § 1 of art. 3rd;
  2. Up to eight months after the end of the stage mentioned in the above point 1.
    The results from the trial phase will need to undergo analysis, validation report and correction by the competent federal health surveillance agency, via the Management Committee
  3. Up to three years after the end of the stage mentioned in above point 2.
    This is for the complete implementation of the National Medicines Control System

 The focus for Brazil’s serialization requirements can be narrowed down to three key areas:

  • Secondary packaging Serialization
  • Aggregation down to shipperbox level (which is mandated in ANVISA’s RDC 157 Art. 7.)
  • Reporting of shipping and receiving supply chain products, aggregation, repository and any destruction caused as well as commissioning of goods.

Serialization Packaging

All commercial packaging must have clear markings and it is compulsory that they include the following UIM – the Unique Medication Identifier markings:

  • A unique Global Trade Item Number – GTIN-14 (Specified in ANVISA’s RDC 157 Art. 6). The GTIN can not be reused as per the GS1 specifications and must be randomized to include up to 20 alphanumeric characters
  • The registration number given by ANVISA 
  • Serial numbers for the products
  • Expiry dates of the goods
  • All batch numbers

It’s not mandated as of yet, but it’s a good practice to add GS1 DataMatrix to the packages and have them encoded with the entire UIM. 

Serialization Reporting

Reporting requirements for Brazil are less complex than other countries like Russia (MDLP) or Saudi Arabia. There will need to be reporting to a centralized repository which is a mandate for commissioning, aggregation, supply chain (shipping and receiving), and destruction. The reporting will need to be done in a horizontally, chronological order for an MAH within 3 business days after the occurrence has been reported of the event. To report by uploading, a user will need to either upload a CSV file manually through a web interface or upload EPCIS XML files using webservices.

Serialization reporting for the Law 13,410 as of now is believed to be optional for the following drug categories:

  1. Over-the-counter
  2. Large Volume Parenteral Solutions
  3. Drugs belonging to the Ministry of Health’s Programs, for free distribution and individualized delivery control 
  4. Specific kinds of drugs (herbal and dynamized)
  5. Injectable contrast media
  6. Serums and vaccines that are part of the National Immunization Program
  7. Free samples
  8. Radiopharmaceuticals
  9. Medical gases 

Our entire team at CosmoTrace has kept up with all the changing updates and is aware as well as well equipped to navigate through the relevant requirements. Our goal is to help manufacturers operating in the Brazilian market achieve SNCM compliance.  We can assist your business prepare for all the upcoming deadlines till May 2022. If you have questions or would like to know more about the SNCM regulations, contact us today:

info@cosmotrace.com
Tel: +44 203 097 1597

 

References
**Law: 2009-11-903, modified in Law: 2016-13-410

Resolution: RDC 157/2017

Resolution: RDC 319/2019

Please visit ANVISA’s site for more detailed information: 
http://portal.anvisa.gov.br/rastreabilidade

 

 

About CosmoTrace

CosmoTrace was formed by an expert, experienced team that has since worked extensively with every part of the pharmaceutical supply chain from manufacturing through to final distribution. As Serialization Consulting Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions.

We offer premium support and services that can help your business with serialization implementation. Our team of experts ensure that you are up to date with all global traceability regulations and will help in creating a successful long-term serialization strategy.

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