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Brazil’s National Medicine Control System Is Coming in 2022. Will You Be Ready?

Vinicius Bagnarolli, Director of Operations in Latin America for rfxcel, says the time to start preparing is now.

Sweeping changes are coming to Brazil’s pharmaceutical supply chain. Since 2009, the Brazilian Health Regulatory Agency (ANVISA) has been honing the National Medicine Control System (SNCM), a traceability system designed to establish mechanisms and procedures for tracking and tracing drugs. After several amendments and resolutions and a one-year pilot phase, SNCM will go into full effect in May 2022.

rfxcel, the leader in track and trace solutions for the pharmaceutical industry, has prioritized helping Brazilian companies prepare for SNCM. Though the system will not “go live” for 34 months, Vinicius Bagnarolli, rfxcel’s Director of Operations in Latin America, says pharmaceutical companies should start preparing now.

“Three years may seem like a long time, but it’s not,” he says. “SNCM requires pharma companies to do a lot of new things and adopt new behaviors. This includes implementing unit-level serialization, tracking and tracing products, and monitoring environmental conditions as they move through the supply chain. Companies will also have to submit detailed transaction data to the government. We want companies, distributors, and dispensers to know that we have the technical expertise and experience in Brazil to help them transition to SNCM. We are on the ground in Brazil; we are here to help.”

SNCM is essentially a modernization scheme: Every supply chain actor must be able to capture, store, and exchange data electronically. All products must have a GS1 DataMatrix bar code that houses a Global Trade Item Number (GTIN), an ANVISA Medicine Registry Number, a unique serial number, an expiration date, and a lot/batch number. Such internationally accepted measures will enable Brazil to protect its almost 190 million citizens against common problems in the drug supply chain, including counterfeit drugs and cargo theft.

“This is a great step for my country,” he says. “Europe and the United States have implemented similar laws successfully. Brazil is the biggest economy in Latin America and is among the biggest in the world; SNCM should be celebrated as a statement of intent that Brazil’s drug industry will follow global quality trends.’’

Bagnarolli also stresses that companies in Brazil must realize SNCM is here to stay, that ANVISA is not going to “babysit” the pharma industry, and that stakeholders must be proactive now to avoid complications with infrastructure and compliance later. “The industry’s business is to sell medicine. rfxcel’s business is supply chain technology. We want companies to focus on what they do best and let us do the rest.”

rfxcel Vice President of International Business Mark Davison agrees. “Organizations in the medicine supply chain urgently need clarity and support from experienced traceability solution providers,” he says. “SNCM is challenging, but rfxcel has built its requirements into existing business workflows, creating opportunities to improve patient safety and supply chain efficiency.”

rfxcel’s main advantage is experience. In business for 15 years, it has deployed its cutting-edge track and trace software to hundreds of companies in the world’s largest markets, including the United States, the EU, India, Russia, and Saudi Arabia. It manages billions of serial numbers, empowering companies with fine-tuned, unit-level, actionable data that optimizes performance and safety while mitigating logistical, environmental, and compliance problems.

Trust, accountability, and transparency are other value-adds rfxcel brings to the table. Every step a customer takes with rfxcel is visible to its team and a dedicated rfxcel team. From onboarding and training to implementation and real-time support, rfxcel works hand-in-hand with its customers to ensure their supply chains are safe, efficient, optimized, and fully compliant.

Bagnarolli wants pharma stakeholders in Brazil to ask themselves several important questions:

  1. How will you develop your ANVISA onboarding framework?
  2. What should you do between now and 2022, before the definitive implementation plan rolls out?
  3. What is the best way to incorporate GS1 DataMatrix codes and serial numbers?
  4. What are your options for partnering and collaborating with your trading partners to ensure you meet all requirements by 2022?
  5. How can you guarantee compliance to avoid fines, supply chain delays, product confiscations, and financial losses?

“These are complex questions,” he says. “But rfxcel is ready to provide guidance and analytics on how to best approach the new regulations. Our unique software capabilities have helped companies around the world meet stringent compliance requirements, safeguard their supply chains, and expand their markets.”

Bagnarolli concludes by saying that rfxcel’s main concern is to make Brazil’s pharmaceutical industry safer. Noting that the country’s pharma market is valued at roughly $31 billion — the sixth largest in the world — he says, “We are here to build relationships based on trust so companies can be compliant by 2022. We want to talk about and advise on the hard work it will take to meet technical requirements, build new teams, and communicate and integrate with trading partners.”

Bagnarolli invites companies to contact him for a consultation. He envisions hosting a webinar or similar training sessions, and welcomes opportunities to visit companies to help them be ready for SNCM.

For more information contact us at latam@rfxcel.com

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet

requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software platform delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

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