Insights

Addressing the Challenge of Serialization in Brazil 

By Upender Solanki, Managing Director, Americas

The development and production of innovative pharmaceuticals as well as their safe distribution along global supply chains are key to maintain and improve public health. In Latin America, Brazil takes in a leading role in the life sciences sector with a market share of 4.1 % and “the highest pharmaceutical market value” in the region. Because of this heavy involvement in the industry, the Brazilian government wanted to ensure product integrity and improve patient safety. They looked to other legislation enacted around the globe, such as EU FMD and U.S. DSCSA. 

In 2016, Brazil started formalizing their pharma serialization journey by enacting Federal Law 13,410. It was an update to an earlier 2009 regulation that put the Brazilian Drug Control System in place. 

Further clarifications were required and in 2020, Brazil’s pharma regulation branch, ANVISA, issued updates to their serialization regulations. This blog will review the key aspects of the latest regulation and explore how pharma stakeholders can work towards future-proof compliance while also improving their operational efficiency.

What Is ANVISA? 

ANVISA (Brazil National Agency of Sanitary Surveillance) regulates the food and health industry, from its production to testing to distribution. As a relatively new branch of Brazil’s government, founded formed in 1999, they continue to form regulations and standards for the entire country including the latest traceability and reporting requirements for pharmaceutical products.  

Brazil’s Pharma Regulation Laws 

Serialization 

The purpose of pharma serialization is to keep the supply chain of pharmaceuticals transparent from production to consumption. With that, the government and medical offices can be sure of the source and location of pharmaceuticals at any time.  

The new regulation requires that each product has its unique medication identifier (IUM), a GS1 2D data matrix barcode, for tracking. The IUM consists of  

• Global Trade Item Number (GTIN)  
• ANVISA registration number 
• Unique serial number 
• Expiration date of the drug  
• Lot/batch number of the product 

Reporting  

Part of Brazil‘s new regulation laws regards the way pharmaceutical companies report, and which actions they report, to the governmental repository SNCM (National Medicine Control System).  

Pharmaceutical companies must report the following six messages to the SNCM system including the last two messages for handling exceptions: 

Activation (relevant to Market Authorization Holders):

• Activation existence of the drug that will be introduced in the drug distribution chain 
• Must be done by the registration holder in SNCM, no drug may be handled in the Brazilian market without its  activation
• CMO supply the Activation event must inform the ID of physical site, needs to be authorized  / registered  by ANVISA
  

Dispatch (relevant to Market Authorization Holders, Distributors, and Dispensers): 

• Sending traceable package(s) to another member of the drug distribution chain, even if the recipient member belongs to the same economic group. 

Receipt (relevant to Market Authorization Holders, Distributors, and Dispensers): 

• Receiving one or more traceable commercial packages from another member of the drug distribution chain, even if the sending member belongs to the same economic group as the receiving member.

 Completion (relevant to Market Authorization Holders, Distributors, and Dispensers): 

• Final operation of the distribution of the drug is understood as an event of “completion”, whose instance may be one of several possible.

Replacement (relevant to Market Authorization Holders, Distributors, and Dispensers): 

• Replacement of an Event Instance, a new version of the event instance to the SNCM. The first event instance is called “substituted”, and the last is called “substitute”

Revocation (relevant to Market Authorization Holders, Distributors, and Dispensers): 

• Revocation of an Event Instance a previously communicated, should be disregarded for the purposes of the SNCM.
  

Since many of Brazil’s pharma sources are from outside the country most of the reporting is aggregation, shipping and receiving, and product destruction. 

The Time to Become Compliant Is Now 

With the April 2022 deadline quickly approaching, companies manufacturing or importing pharmaceuticals in Brazil should be planning their implementation process for the law through a series of phases.  

Track and trace software solutions are an ideal way for pharmaceutical companies to integrate and share their data so that it complies with ANVISA regulation. Providing a serialization repository and management, these solutions facilitate the  

• application of unit-level serialization with a GS1 2D data matrix barcode 
• connection with the government repository (SNCM) for reporting of product movement 
• exchange of serialization data with business partners including CMOs, MAHs, Third-Party Logistics Service providers, and customers 
• tracking of product movement including aggregated units  
• efficient handling of business processes, as the serialized product moves within the 4 walls of an organization 

Additionally, track and trace technologies can provide benefits beyond compliance: 

• Connected supply chain networks from production to end of life 
• Real-time insights 
• Ensured product authenticity  
• Future-proof compliance with global regulations 
• Deviation monitoring and solutions  
• Remove the need for buffer stock  
• Reduced product idle time  

We’re ready to help! Schedule a 1:1 session with our experts to outline the next steps in digitalizing and automating your supply chain tracking while ensuring compliance with global serialization regulations.