Systech, a division of Markem-Imaje specializing in serialization solutions, as well as tracking, location and brand protection, has announced a solution for the serialization of pharmaceutical products. The system adheres to the requirements of Brazil’s National Health Surveillance Agency (Anvisa), whose rules must be met by May 2022, according to the government’s official schedule. Pharmaceutical laboratories that manufacture medicines or import them into Brazil must adapt to the new regulations. Anvisa’s drug-control system defines the procedures for collecting, storing and transmitting product data across the supply chain. As a result, drug-distribution companies are obliged to submit detailed data to the federal government regarding product transactions.
Paulo Machado, Markem-Imaje’s strategic account manager, says that with the new rules, resources will be expanded in the country to manage all projects locally. “Our proven software solutions are powerful enough to meet any global regulations,” he states, “yet flexible enough to be valid with new equipment or manufacturing lines.”
Left to right: Paulo Machado, Stacey Owens-Perrotta, Joe Belenardo
Stacey Owens-Perrotta, Systech’s senior manager of global marketing, says the cloud-based technology allows pharmaceutical products to be serialized according to Anvisa’s requirements. “All countries have a form of regulation in which drugs cannot pass through the supply chain,” she explains, “without being serialized on the packaging by bar codes or 2D,” such as QR codes or digital printing, for example. “A manufacturer cannot sell its drugs unless it complies with these regulations.”
The Brazilian drug market, estimated at US$48 billion, is growing rapidly, according to data from Systech. “At the moment, it is one of the most attractive and promising pharmaceutical markets in the world,” Owens-Perrotta says. In addition, the Brazilian generic drug industry is growing rapidly to compete with other major global economies.
According to Owens-Perrotta, the idea of serialization involves preventing the counterfeiting and diversion of products, but it has not been enough to prevent criminals from taking action. “Bar codes and 2D matrices on the packaging can be replicated or copied so they cannot be the answer to the problem,” she states. “Therefore, there are other technologies that are layered on serialization to add extra protection to each product.” These technologies include e-fingerprinting, Systech’s UniSecure mobile solution, holograms, tamper-resistant seals, special inks and more.
Joe Belenardo, Systech’s global VP of sales and marketing, says all new regulations are complicated. “For this reason,” he states, “Systech has developed a program for Brazil that includes a set of combined solutions and offers the industry the best services for serialization, traceability, implementation, reporting, training and technical support.” The company has experience in more than 50 serialization facilities with large, multinational pharmaceutical laboratories, he says, adding, “With fully integrated solutions in place, we can meet local and global requirements perfectly, without needing multiple suppliers. We have been pioneers in serialization for over 30 years and remain the trusted supplier to the world’s leading pharmaceutical laboratories.”
Systech video art
Serialization affects all partners in the supply chain: brands, contract manufacturers, packers, logistics providers, distributors, hospitals and pharmacies. Pharmaceutical companies are starting to plan the process now to better understand requirements, establish resources and cost efficiencies, and ensure project completion on time. Systech has developed a software suite for authentication and traceability that is intended to combat counterfeiting, prevent diversion and comply with regulations. The firm offers a brand-protection solution in a suite of products that provide real-time insights, product data, digital connectivity and consumer engagement. The system is now being used by several global brands to maintain product authenticity across the supply chain.