- A Q&A document released by ANVISA addresses top industry questions about serialization, labeling, and reporting in regard to the Normative Instruction.
- The SNCM portal for submitting required Serialization Plans was made available on October 6.
- Time is limited: Companies have 30 calendar days from October 6 to submit their Serialization Plans.
On September 23, ANVISA published version 1.0 of “Perguntas & Respostas” to address pressing questions from manufacturers, distributors, dispensers, logistics providers, and solution providers regarding the final Normative Instruction for serialization and reporting to Brazil’s central SNCM system. At this time, ANVISA has not published an official version in English. This summary is based on reading and analysis by TraceLink’s Brazil office and the TraceLink Community’s Brazil Special Interest Group. The Q&A is broken into four sections:
Section 3.1: Serialization Plan
All ANVISA Registry Holders—companies that have registered medicines for sale and distribution in Brazil—are required to complete a Serialization Plan through the SNCM portal within 30 calendar days of the portal being made available. This Serialization Plan covers readiness activities from the present up until April 28, 2022, the implementation deadline for all stakeholders for both serialization and reporting of activation and shipping events.
Section 3.2: Medicines Subject to Serialization and Reporting
ANVISA clarifies the “government destination” exemption for Article 4 of the Normative Instruction to refer to medicines that are part of government programs and dispensed via the Sistema Único de Saúde (SUS). This section also states that “productos acabados” (finished products) labeled and packaged prior to April 28, 2022 do not need to be serialized, even if they are released to the market after that date. Products labeled and packaged after April 28, 2022 are required to be serialized and their activation and shipping reported.
Section 3.3: Labeling and Aggregation
The Q&A refers companies to the GS1 barcode standards and states that companies can begin applying unique identifiers (IUMs) and 2D data matrix codes to packaging immediately after notifying ANVISA. One question still under discussion is whether or not serialized products released to the market prior to the April 2022 deadline are subject to reporting requirements.
Section 3.3 also states that the standard for the Transport Packaging Identifier (IET)—specified in the regulations as a “package identifier that shows the relationship with the IUMs of the drugs it contains”—is not defined by law but rather by the industry, and cites the GS1 standard Serialized Shipping Container Code (SSCC) as an example of an industry standard.
Section 3.4: Reporting to the SNCM
As expected, all supply chain stakeholders are required to develop or contract a solution to connect to the SNCM in order to report serialization events. The Q&A establishes the timeline for reporting the initial Activation Event for domestic products (serialized and packaged in Brazil) that are ready to be shipped, regardless of when its quality assurance release takes place. The ANVISA Registry Holder has 3 days to report activation, which must be completed prior to shipment.
For products that have been packaged and labeled outside of Brazil and imported, activation must be reported within 3 days after the product clears Brazil customs and prior to being released into the Brazil market. Because this response differs from previous ANVISA guidance on imported products, there continues to be discussion about the timing of Activation Events.
In addition, several questions address reporting requirements and responsibilities at different points in the supply chain, including:
- Requirements for reporting on product movements between companies with different tax IDs (CNPJs)
- The need for establishing horizontal communication between supply chain partners to exchange serialized product data due to the confidentiality of data reported “vertically” to the SNCM.
- The exclusion of transport companies from reporting requirements.
- Tracking responsibilities and exemptions for healthcare systems, dispensers, and the Sistema Único de Saúde (SUS).
ANVISA expects to publish new Q&A releases as it gathers additional questions from the industry via meetings and emails.
The window is closing for uploading your Serialization Plan
Access to the SNCM portal was made available on October 6 for registry holders to publish their serialization plans as required by the final Normative Instruction.
- Companies have 30 calendar days from the availability date (October 6) to submit their plan.
- A digital certificate issued by the Brazilian government to the registry holder’s headquarters is required to identify the legal entity and to connect to the system.
- The serialization plan input form requires that companies provide an extensive set of information about their serialization operations, including the number of SKUs that will be serialized as well as manufacturing and distribution locations.
- Using the company-supplied information, the portal generates a Gantt chart that provides a timeline for achieving serialization and reporting readiness by April 28, 2022.
- Once a plan is registered, companies will have access to a monitoring dashboard and are expected to keep their plans up to date.
ANVISA has published a Serialization Plan manual to help companies publish and update their serialization plans. The manual is currently available only in Portuguese.
30 weeks to go. Be ready with TraceLink.
With fewer than 7 months until the final deadline, TraceLink continues to monitor the status of the SNCM system and ANVISA responses to industry questions. Count on TraceLink for the proven compliance solutions and local support you need to be sure that you—and your affiliates—can meet Brazil’s complex serialization, traceability, and reporting requirements by April 28, 2022. Only TraceLink gives you the ability to Integrate Once, Interoperate with Everyone™ to quickly connect your CMOs and 3PLs and build a downstream partner network without costly, time-consuming integrations.
Contact TraceLink to schedule a Brazil Readiness Workshop today.