Brazil Serialization Requirements
Brazil is one of the markets that is pushing hard to implement legislation. While anti-counterfeiting is one of the drivers for the initiative the high risk of tax evasion is definitely an additional issue that the BRazilian Government wants to tackle.
The Brazilian government body ANVISA published Resolution RDC 54 on December 10th, 2013. RDC54 already covers quite some details about how track and trace in Brazil should look like. It clearly states the applicability to all prescription drugs subject to registration at the National Health Surveillance Agency and explicitely includes free samples!
In addition the following requirements are included:
- Serialization on unit level is explicitly required.
- It is also required by the Registration Holder to track any unit down to the point of dispensing.
- Imported products have to be serialized before import.
- Tracking will be based on the Unique Medication Identifier Code (UIM), which includes
- Medication Record number at Anvisa (13 digits),
- Serial Number (numeric 13 digits),
- Expiration Date,
- Lot Number.
- Aggregation is required as per Art 9 §2 which states that the transport packaging must contain an identification code in which all IUM that composes the packaging is related.
Chapter 3, Art 7 explicitely calls for non-deterministic randomization of serial numbers and for serial numbers that must be unique across the product produced by the MAH. In the meantime it was clarified however that both requirements wil be implemented in a reduced fashion: deterministic randomization will be accepted and only the serial numbers for products that will be sold in Brazil have to be unique.
As per the orginal legislation as defined in RDC 54, no central government operated database was planned. However, in the recently published “Normative Instruction” of August 2014 a government database is explicitly mentioned. In addition, the Normative Instruction covers the following:
- Necessity to communicate events from Medication Registration Holder (=MAH) to Anvisa (Art. 1, Art. 10)
- Necessity to communicate events between supply chain participants (Art. 1,§1, Chapter III). This means that every participant in the supply chain has to send logistic events
- to the MAH (Art. 4),
- to the receiving chain member (Art. 6) and
- to the previous supply chain member (Art. 4) .
Supply Chain members also have to send all communication received from the posterior chain member to the previous chain member and the MAH (Art. 5) and have to send differences between declaration and real product to both to previous supply chain member and MAH (Art. 6, §2)
- The MAH is responsible to monitor logistic movements (Art. 1,§4) as defined in Art 2, Chapter II, including the Creation (medication “emerges”), Change of ownership (“passage between members”) and Decommissioning (“extinction”) of medicinal products.
- Art. 3 cover the definition of “Logistic Events” and includes „purchase“ and „sales“ which in SAP‘s view are not logistic events and needs to be further clarified, but it also explicitely includes Free Samples.
- The normative instruction also includes the requirement to report “anormalous events” (Art. 12) like movement of medication with IDs not generated by MAH, Duplication of IDs and rReporting of decommissioned IDs.
So overall, this will result in a huge number of messages being sent back and forth as layed out in the use cases below.
To ease the pain of sending all the messages back and forth a network model is currently in discussion and in the past few weeks some more details have emerged through the collaboration with the different stakeholder organizations like interfarma and Sindusfarma. Stay tuned for some more news!
PS: The original documents and english translations are available and can be shared with SAP Customers.