Tuesday, July 16, 2024

New Decrees Prompt Regulatory Adjustments at Anvisa Starting This Month

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New decrees take effect in June, requiring adjustments in National Health Surveillance Agency’s (Anvisa) regulatory procedures. Starting this month, two new federal government decrees, Decree 11,243, dated October 21, 2022, and Decree 12,002, dated April 22, 2024, will come into force, necessitating changes in procedures aimed at improving regulatory quality. These procedures are outlined in the following Anvisa regulations: Portaria 162, dated March 12, 2021, and Service Guidance 96, dated March 12, 2021.

The main alteration, published last Wednesday (May 29), pertains to the exemptions from Public Consultation (PC), which will now follow the same criteria as exemptions from Regulatory Impact Analysis (RIA):

  • Urgency
  • Low impact
  • Convergence with international standards
  • Adherence to superior regulations that do not permit alternative regulatory options
  • Updating or revoking obsolete norms without changing their essence
  • Reducing requirements, obligations, restrictions, requests, or specifications to lower regulatory costs
  • Revising outdated norms for technological adequacy, as per Decree 10,229/2020
  • Non-applicability of RIA, as provided in § 2 of art. 3 of Decree 10,401, dated June 30, 2020

New Regulatory Rules for Public Consultation Exemptions and Durations at Anvisa

The exemption from PC due to being unproductive, which was included in Portaria 162/2021, is no longer applicable. Additionally, in cases of PC exemption due to low impact, convergence with international standards, or technological adequacy, another form of social participation mechanism will be required. Publications of consultations will now include more detailed information, including links to the Anvisa disclosure page and the Participa + Brasil electronic portal, which is expected to centralize and publicize federal government public consultations.

Furthermore, unless involving urgent situations, PCs will now have new minimum duration periods. PCs approved from June 1 onwards that significantly impact international trade must last at least 60 days. For other cases, the minimum period of 45 days remains for the public to submit comments and suggestions. To improve internal procedures, there has been a specific change regarding the Regulatory Agenda flow, which can now be updated at any time and extraordinarily to include new periodic update themes.


Official Gazette Publishes Changes to Anvisa’s Regulatory Quality Guidelines and Procedures

Published in an extra edition of the Official Gazette on Wednesday (May 29), Portaria No. 673, dated May 29, 2024, establishes the necessary changes to Portaria No. 162, dated March 12, 2021, which deals with the guidelines and procedures for improving regulatory quality at Anvisa. On the same date, Service Guidance No. 131, dated May 29, 2024, was published, amending Service Guidance No. 96, dated March 12, 2021, which outlines the flow for the development and deliberation of regulatory instruments.

These changes were necessary to align internal regulations with the provisions of Decree No. 11,243, dated October 21, 2022, and Decree No. 12,002, dated April 22, 2024. Decree No. 11,243/2022 takes effect from June 9, 2024, and addresses measures to be adopted to promote good regulatory practices within the Federal Executive Branch to comply with Annex II of the Trade and Economic Cooperation Agreement between the Government of the Federative Republic of Brazil and the Government of the United States of America Related to Trade Rules and Transparency. Decree No. 12,002/2024 took effect on June 1, 2024, establishing norms for the preparation, drafting, modification, and consolidation of normative acts.


Resource: National Health Surveillance Agency, June 07, 20

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