Systech Delivers Comprehensive Serialization and Track & Trace Solution to Meet Brasil’s ANVISA Pharmaceutical Regulation
Sao Paulo, Brasil – (April 22, 2020) Systech, a division of Markem-Imaje and the global leader in serialization, track and trace, and brand protection solutions, today announced it is offering an integrated pharmaceutical serialization compliance program to meet Brasil’s May 2022 Agencia Nacional de Vigilancia Sanitaria (ANVISA) requirements deadline.
Pharmaceutical companies manufacturing in or importing into Brasil are required to follow upcoming regulations set forth by ANVISA, a Brasilian health regulatory agency. ANVISA’s Sistema Nacional de Controle de Medicamentos (SNCM) is the national drug control system that defines the procedures for capturing, storing and transmitting product data across the supply chain. Brands, wholesalers and dispensers will be required to conform to the regulation by submitting detailed product transaction data to the Brasilian government.
Brasil’s drug market is approaching $48 billion and growing fast. It’s now one of the most attractive and promising pharmaceutical markets in the world. In addition, Brasil’s market for generic drugs is growing rapidly to compete with other larger, global economies. “All new regulations are complicated, so Systech has developed a program for Brasil that includes a combined solution set, offering industry leading serialization, traceability, implementation, reporting, training, and technical support services,” says Joe Belenardo, vice president global sales and marketing at Systech.
Mr. Belenardo continued, “Our extensive experience includes over 50 serialization installations with large multinational pharmaceutical customers in Brasil. With fully integrated L1-L4 solutions in place, we can meet local and global requirements seamlessly, without the need for multiple vendors. We pioneered serialization over 30 years ago and remain the trusted provider for the world’s leading pharma companies.”
Serialization affects all partners in the pharma supply chain. Brands, contract manufacturers, packagers, logistics providers, distributors and ultimately hospitals and pharmacies. Pharma companies are beginning the planning process now to better understand requirements, establish resource and cost efficiencies, and ensure on-time project completion.
“With the regulations becoming effective in 2022, we have expanded our resources in Brasil and locally manage all projects,” says Paulo Machado, Strategic Account Manager for Markem-Imaje. “Our proven software solutions are powerful enough to meet any global regulation, yet flexible enough to hold true with new equipment or retrofitted manufacturing lines.”
Jefferson Barr, VP Marketing