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.
- 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.
- 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.
- 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.