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)