Brazil Regulatory Updates

This is a compilation of the recent regulatory updates for Brazil. Every week, we post an update of what's new, which you can view here.

2022

• May 22: On May 23, ANVISA announced that they would temporarily suspend the SNCM testing and production environments to review the contract with Dataprev. The suspension is in response to the recently passed “e-leaflet” Law 14.338.
• May 22: The next DICOL meeting is scheduled for June 8.
• May 15: Law 14.338 has amended Law 13.410 (2016) and 11.903 (2009).
• May 15: ANVISA is expected to publish a new RDC and a new Normative Instruction, the approval of which takes place at a DICOL meeting.
• May 15: The next DICOL meeting agenda on May 25 does not contain the SNCM or e-leaflets.
• April 24: The SNCM implementation legal deadline goes into force on April 28, 2022.
• April 24: Bill 3846 to provide for digital package inserts (e-leaflets) and which may impact serialization and reporting requirements is awaiting President's signature; deadline is May 11, 2022.
• April 24: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (Bill 2552) that would delay SNCM implementation by 3 years.
• April 24: ANVISA authored a new RDC and a new Normative Instruction. However, those documents were removed from their scheduled discussion at the April 27 DICOL meeting.
• April 17: There were further legislative developments on Bill 3846 to provide for digital package inserts (e-leaflets) which may impact serialization and reporting requirements:
  • ANVISA published a statement of opposition to Bill 3846 and is pushing for re-discussion amongst lawmakers.
  • SINDUSFARMA published their position as “partially in favor” to Bill 3846 by supporting the e-leaflet principle but recommending that the serial number be kept mandatory to support serialization and reporting to the SNCM.
• April 17: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (Bill 2552) that would delay SNCM implementation by 3 years.
• April 10: There were further legislative developments on a bill to provide for digital package inserts (e-leaflets) which may impact serialization and reporting requirements. ANVISA published a statement of opposition to this Bill and is pushing for re-discussion by lawmakers.
• April 10:  there has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552/2021) that would delay SNCM implementation by 3 years.
• April 3: Dataprev, operator of the government traceability platform (SNCM), has stated ANVISA’s intention to have a Production system ready for the country’s April 28, 2022 compliance deadline.
• April 3: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552/2021) that would delay SNCM implementation by 3 years.
• March 27: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552/2021) that would delay SNCM implementation by 3 years.
• March 20: ANVISA published the first version of the Test SNCM Connectivity Guide authored by Dataprev, the technical provider for the national traceability system.
• March 20: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552/2021) that would delay SNCM implementation by 3 years.
• March 20: ANVISA expressed a contrary opinion to Bill PL 3846/2021, which would allow for digital package inserts, but whose provisions in current form would indirectly affect SNCM implementation.
• March 6: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552) that would delay SNCM implementation by 3 years.
• February 27: There has been no update to the February 16 “Urgency Request” presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552) that would delay SNCM implementation by 3 years.
• February 20: On February 16, an “Urgency Request” was presented to the Chamber of Deputies to accelerate debate of the proposed law (PL 2552) to delay SNCM implementation by 3 years. No decision or debate date has been set.
• February 20: SINDUSFARMA’s 2-hour traceability meeting on February 16 was attended mostly by manufacturers to discuss ANVISA’s recent Q&A update and its implications on reporting imported goods.
• February 20: GS1 and Sindusfarma reiterated that companies should continue their serialization and track-and-trace implementations according to the law currently in place.
• February 13: TraceLink met with DATAPREV to discuss technicalities of the SNCM system. DATAPREV SA was selected by ANVISA as the operator of the SNCM, Brazil’s vertical reporting system.
• February 13: SINDUSFARMA held a 2-hour traceability meeting for all stakeholders on February 16 to discuss ANVISA’s latest SNCM FAQ v1.1
• February 13: There has been no official word on the proposed three-year delay to mandatory traceability reporting to the SNCM.
• February 6: DATAPREV SA was selected by ANVISA as the operator of the SNCM, Brazil’s vertical reporting system.
• February 6: TraceLink has been contacted by ANVISA to begin testing activities. The team is awaiting a digital certificate to connect to the testing environment.
• February 6: The proposed delay for the SNCM has been put to the Comissão de Constituição, Justiça e Cidadania (CCJ) for potential fast-tracking of the legislation.
• February 6: SINDUSFARMA will be holding a 2-hour traceability meeting for all stakeholders on February 16 to discuss ANVISA’s latest SNCM FAQ v1.1.
• January 2: The proposal (“Law Project” 2552/2021) to delay SNCM implementation by 3 years, is expected to be considered by the Chamber of Deputies not before February 2022. GS1 advises stakeholders to continue with implementation to meet the April 28, 2022 deadline.

2021

• December 19: A bill (“Law Project” 2552/2021) has been proposed by the Brazil legislature to delay SNCM implementation. The bill is expected to be considered by the Chamber of Deputies in February 2022.
• December 5: Serialization Plan submission to the SNCM portal is optional with the recent amendment to the Normative Instruction (version 108). Some companies have stated they will have their Serialization Plan on hand in case of inspection.
• November 28: ANVISA modified the Normative Instruction to make submission of Serialization Plan to the SNCM system optional. However, the remaining requirements for the Serialization Plan remain in place.
• November 28: ANVISA reiterated the April 28, 2022 deadline for 100% serialization and reporting.
• November 28: GS1 Brazil published v1.0 of the Horizontal Communication specifications on the GitHub platform.
• November 14: ANVISA has not set a date for its Serialization Plan Webinar, which would start the 30-day clock for companies to submit their serialization plans.
• November 7: Serialization Plans are no longer due on November 5. ANVISA plans to hold an explanatory webinar, after which companies will have 30 days to submit their plan.
• November 7: There has been no update on the status of GS1 Brazil’s Horizontal Communication Guide, which had been scheduled for release on October 27.
• October 31: GS1 Brazil did not present the Horizontal Communication guide at the GS1 Public Policy meeting on October 27.
• October 31: Serialization Plans are nominally due on November 5, according to the 30 calendar-day timeline from the final Normative Instruction. The timeline is measured from the availability of the SNCM portal on October 6.
• October 24: GS1 Brazil will present the latest version (v1.0) of its Horizontal Communication guide at the October 27 GS1 Public Policy meeting.
• October 24: Serialization Plans are nominally due on November 5, according to the 30 calendar-day timeline from the final Normative Instruction. The timeline is measured from the availability of the SNCM portal on October 6.
• October 17: As of October 6, ANVISA has made the SNCM Portal available for companies to submit their Serialization Plans. According to the Normative Instruction, stakeholders have 30 calendar days from that date to upload their information.
• October 17: The industry is seeking clarification on question 3.4.3 from ANVISA’s “Questions and Answers on SNCM Implementation.” The question deals with activation report requirements and timing for finished goods vs. commercializable goods.
• October 10: ANVISA has made the SNCM Portal available for submitting Serialization Plans as of October 6. According to the Normative Instruction, stakeholders have 30 calendar days to submit their plan.
• October 10: Industry is seeking clarification on question 3.4.3 of ANVISA’s “Questions and Answers on SNCM Implementation.” The question deals with the reporting and timing of the “Activation Event” of finished goods based on whether they are produced domestically or imported.
• October 3: The Brazil government’s website states that the ability to submit the “Serialization Plan” will be made available soon.
• September 26: ANVISA published v1.0 of its “Questions and Answers on SNCM Implementation” document, which covers serialization and reporting deadlines for finished product, reporting in case of movement to another storage location, medications exempt from serialization and reporting, and other details not always explicitly described in the Normative Instruction.
• September 19:  The Normative Instruction was approved at the August 20 directors’ (DICOL) meeting. It defines April 28, 2022 as the final date to start serialization and reporting.
• September 19: There has been no update on the availability of the SNCM portal, which will define the deadline for submitting a Serialization Plan as required by the Normative Instruction. GS1 Brazil suggests that the Serialization Plan template will likely follow the previous version of the “Implementation Plan”.
• September 5: The Normative Instruction was approved at the August 20 directors’ (DICOL) meeting. It defines April 28, 2022 as the final date to start serialization and reporting.
• September 5: Industry discussions are focusing on horizontal communication, with some pharma companies indicating that their downstream distribution partners have not committed to this form of data exchange.
• September 5: The 30-day window for submitting a Serialization Plan will be dependent on the availability of the SNCM production system, which is not yet available.
• August 29: The Normative Instruction was approved at the August 20 directors’ (DICOL) meeting. It defines April 28, 2022 as the final date to start serialization and reporting.
• August 29: Industry discussions are focusing on horizontal communication, with some pharma companies indicating that their downstream distribution partners have not committed to this form of data exchange.
• August 29: The 30-day window for submitting a Serialization Plan will be dependent on the availability of the SNCM production system, which is not yet available.
• August 22: ANVISA’s collegiate directorate (DICOL) approved the Normative Instruction at its August 20 meeting, setting the April 28, 2022 serialization and SNCM deadline. While ANVISA recognizes the challenges for the industry to fully implement their serialization, traceability, and reporting solutions by this date, it stated that the law dictates the deadline and that serialization requirements themselves have been well communicated.
• August 15: The ANVISA directors (DICOL) plan to discuss the draft Normative Instruction at its next meeting, now scheduled for August 20.
• August 8: The latest draft version of the Normative Instruction was published on July 13, which mandates 100% readiness across the supply chain by April 28, 2022. The next ANVISA Directors' (DICOL) meeting is August 18 and includes discussion of the Normative Instruction on the agenda.
• August 1: There are no updates to the latest draft version of the Normative Instruction circulated on July 13, which mandates 100% readiness across the supply chain by April 28, 2022. The agenda for the August 4 ANVISA Directors (DICOL) meeting did not contain the Normative Instruction, but it does address some adjacent topics on quality management. The next scheduled meeting is August 18.
• July 25: The latest draft version of the Normative Instruction circulated on July 13 mirrors Brazilian Law: All supply chain stakeholders (manufacturers, importers, wholesalers, dispensers (with the exclusion of national healthcare systems and clinics/health offices) are expected, beginning on April 28, 2022, to report all transactions on serialized products. All in-scope products are required to be serialized by this date. Next meeting of the ANVISA directors (DICOL) meeting is on August 4.
• July 18: A new draft of the Normative Instruction was distributed to Brazilian pharmaceutical associations on July 13.
  • The new draft version mirrors Brazilian Law: All supply chain stakeholders (manufacturers, importers, wholesalers, dispensers with the exclusion of national healthcare systems and clinics/health offices) are expected, on April 28, 2022, to report all transactions on serialized products.
  • All in-scope products are required to be serialized by this date. Unlike previous versions of the NI, this draft does not contain any intermediate deadlines, nor mention of an “Implementation” phase, nor additional exceptions for stakeholders or product classes other than those originally exempted.
  • The new draft requires manufacturers and importers to submit a Serialization Plan to ensure readiness by April 28, 2022. No deadline for submission was indicated.
• July 11: The Normative Instruction was not discussed at the July 7 ANVISA directors (DICOL) meeting. However, a new draft was released on July 13 and ANVISA has invited Sindusfarma and other industry groups to review prior to final approval. Next ordinary meeting is July 22.
• July 4: ANVISA remains in the process of finalizing the Normative Instruction, but there has been no additional information on the degree of change between the latest draft and the March 2021 draft. The Normative Instruction was not on the agenda of the July 8 meeting of ANVISA directors (DICOL).
• June 27: ANVISA remains in the process of finalizing the Normative Instruction, but there has been no additional information on the degree of change between the latest draft and the March 2021 draft. The next meeting of the ANVISA directors (DICOL) is July 8. Some topics on medical devices/UDI (unique device identification) systems were discussed at the June 22 meeting.
• June 20: The next scheduled meeting of the ANVISA Directors (DICOL) is June 22. The Normative Instruction is not on the agenda.
• June 13: The Normative Instruction was not discussed at the ANVISA Directors (DICOL) meeting on June 9. The next scheduled meeting is June 23. 
• June 6: The Normative Instruction was not on the ANVISA Directorship (DICOL) agenda for its June 4 June 9 meetings. The next scheduled ordinary meeting is June 23. Most meeting topics are centered on vaccine approval and distribution issues.
• May 30: The Normative Instruction was not discussed at the DICOL Meeting on May 26. The next scheduled meeting is June 10.
• April 11: The Normative Instruction was not discussed at the April 7 meeting of ANVISA directors ( DICOL), nor is it on the agenda for April 14 due to the nation’s COVID crisis. The next meeting will be April 29.
• March 28: ANVISA’s DICOL meetings took place on March 24 and 25, but the draft Normative Instruction issued on March 12 was not discussed. The current draft of the Normative Instruction, despite clarifying some elements from the previous version, continues to generate discussion on its requirements for both reporting and serialization. Further meetings are scheduled on April 7, 15, and 29.

2020

• January 31: The ANVISA directorate (DICOL) meeting on January 26 did not include traceability on its agenda due to the immediate need to address COVID-related topics. The next meeting will be on February 9.
• January 24: The agenda for the January 26 meeting of ANVISA directors (DICOL) did not contain topics on the SNCM or on traceability compliance. The next opportunity for discussion will be at the February 9 session.
• December 20: The latest draft of the Normative Instruction was not finalized at the December 15 ANVISA directors (DICOL) meeting, but there is speculation that companies will be required to begin “assisted implementation” (a form of reporting to SNCM) beginning in April, 2021. The previous draft requirement for companies to file an “Implementation Plan” by December 31, 2020 is not included in the latest draft of the Normative Instruction. The next DICOL meeting is scheduled for January 26, 2021.
• December 6: The latest draft of the Normative Instruction lists phased deadlines by product class starting in 2022. The next DICOL meeting on December 15 may provide further updates on approval of the regulation. The deadline for companies to register their Implementation Plans remains December 31, 2020.
• November 29: The ANVISA Directorate (DICOL) is scheduled to meet on December 1 and is expected to discuss the Normative Instruction draft.
• November 29: According to GS1 Brazil, first steps in architecture and technology have been made to address the horizontal integration requirement and will use the ANVISA reporting architecture as a starting point.
• November 22: The Normative Instruction was not on the DICOL (ANVISA Directorate) November 17 meeting agenda. The next meeting will be on December 1, when a new draft of the regulation may be approved or when proposed phased deadlines based on discussions between ANVISA and domestic pharmaceutical industry associations may be addressed.
• November 15: Minutes from the ANVISA directors’ meeting indicate the Implementation Plan deadline will shift to December 31, 2020. A new draft version of the Normative Instruction is expected to include phased-in deadlines by product category, beginning with controlled substances and antimicrobial medicines.
• November 8: The ANVISA directorate (DICOL) is formulating a new draft version of the Normative Instruction. Preliminary discussions at the November 4 DICOL meeting indicate that ANVISA may take a phased approach for in-scope products from 2022-2024. ANVISA proposed to move the Implementation Plan publication deadline to December 31, 2020.
• October 25: Due to changes in the membership of the ANVISA board of directors, ANVISA did not take up approval of final regulations/Normative Instruction on October 20. ANVISA did publish version 1.0 of the technical guidelines for connecting to the government reporting system, SNCM.
• October 11: The public discussions held on October 7 did not result in formal approval by ANVISA of the Normative Instructions due to a request by one ANVISA director to further study the drug set covered and possible economic impacts.
• September 27: The Brazilian Health Regulatory Agency (ANVISA) provided an update during last week’s SETRM conference that covered expectations for the December 1, 2020 compliance deadline and highlighted additional requirements for implementation and metadata reporting. ANVISA is expected to approve the Normative Instruction and Technical Guidelines on October 7, 2020.
• August 30: Brazil's SETRM seminar begins next week and will be kicked off with the latest announcements from The Brazilian Health Regulatory Agency (ANVISA) and other authorities on the current expectations for Brazil compliance.
• July 26: The Brazilian Health Regulatory Agency (ANVISA) confirmed that the Normative Instruction is done and is in legal review with the Brazilian Attorney General. ANVISA is targeting August for final publication.
• January 5: The Brazilian Health Regulatory Agency has extended the deadline for commentary on its Normative Instruction phased implementation deadlines. The new deadline is February 17, 2020.

2019

• November 10: The Brazilian Health Regulatory Agency has approved a draft of regulations that lay out initial responsibilities for stakeholders in the country’s pharmaceutical supply chain. The document will soon be published for public commentary.
• April 7: The official pilot phase for serialization in Brazil will end in April 2019. At that time, the government will use learnings from the pilot program to create the final technical guidelines and will publish them in the next few months. The final implementation deadline of April 2022 will not shift, but the implementation timeline is now 24 months instead of 36 months and will begin in April 2020.
• February 24: ANVISA's extended pilot is planned to run in parallel with the eight month review and final regulation period. This timing means the 36 month implementation timeline would begin in April 2019 and end in April 2022 for all companies that have a requirement under the law and the products that are covered by the law.

2018

• June 3: ANVISA reviewed timelines and the pilot will be extended until April 2019. Communication standards are being considered for both vertical government reporting and a potential use for horizontal peer to peer communications. A new version of communications guidelines has been published.
• April 8: Updated SNCM technical guidelines were circulated for law, which is currently in a pilot testing stage.
• March 11: ANVISA published the list of the pilot participants for the May through September pilot.
• January 14: Pilot execution and testing is now going to get underway in April/May when the central system is ready for integration and data management.

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