Secure and Compliant Implementation of Brazilian Drug Serialization Requirements
April 2022 - the deadline is just around the corner
Brazil is one of the largest pharmaceutical markets globally. A Track & Trace solution is an important step to fight against counterfeiter drugs while increasing transparency across the entire pharmaceutical supply chain, from production and distributors to the dispensing of medications in the pharmacy.
The Brazilian Pharmaceutical Industry is regulated by a governmental entity called ANVISA (Agência Nacional de Vigilância Sanitária). By 2009 ANVISA created a specific department, the SNCM “Sistema Nacional de Controle de Medicamentos,” whose primary responsibility is developing and managing a technological solution for the medicines Track&Trace regulation. With the Law RDC 157/2017, created in 2017, ANVISA defined the Go-live April 2022. On the following timeline, we find the different phases of the project with specific action until today.
As April 2022 is just around the corner, all stakeholders of the supply chain that import to Brazil or produce locally are now facing procedural and logistical challenges to act according to Brazilian serialization medicine regulation.
Going on a technical level, the Track & Trace architecture in Brazil is complex where we can identify two flows of communication, vertical and horizontal directions, that increases the project difficulty.
The exchange of messages with ANVISA/SNCM is called vertical communications. All stakeholders on the market are obliged to report the status of the serial number along the supply chain. Main messages are, for example, activation message from the MAH that refers to which products are to be commercialized on the market, expedition message that indicates the movement from point A to point B, and receipt where the entity responsible for receiving the serial numbers must communicate the reception to ANVISA.
Horizontal communications are non-regulated, meaning that the stakeholders aren’t obliged to exchange messages with their partners but only with ANVISA. The issue here becomes more logistical because logistic efforts would be high if there were no messages between the partners. For example, for a reception, we would need to read all the serial numbers, and in case we already have all the data storage on the system, we only need to read the upper level of the aggregation. Thanks to the help of GS1 Brazil and some key people, the market was able to define a standard using the ANVISA format and SOAP technology.
As the last point and to have a complete understanding of the Brazilian market, we identified three main scenarios during the requirements process, each one with their particular exchange of messages and individual solutions. The scenarios are:
- Local Production Scenario - CMO and MAH are in Brazil
- Importation Scenario - CMO is located out of Brazil and MAH in Brazil
- Wholesaler Scenario - solution for horizontal communication (1. The 3PL can receive and send expeditions messages from/to the market partners / 2. Send expeditions, receipt, and completion messages to ANVISA)
Arvato Systems is now offering a complete solution for all existing scenarios on the Brazilian market and especially the ability to implement in a short time. Please get in contact with us so we can evaluate your requirements and present our solution.