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Regulatory Focus™ > News Articles > Brazil: New Board Procedures Established For Oral Arguments

Brazil: New Board Procedures Established For Oral Arguments

Posted 30 April 2012 | By Ansis Helmanis

Major changes to the way ANVISA Board meetings are run were published on 25 April (Ordinance 616/2012).

Companies in the regulated sector will now have two ways to comment during the open phase of the Board meeting:

  • They may request the opportunity to present oral arguments concerning administrative appeals or ask for an opinion.
  • Requests for oral argument must be submitted at least two days before the scheduled Board meeting and if the applicant wishes to have the oral argument closed to the public, the company must explain its reasons in an e-mail to the agency.

Read more:

ANVISA - Ordinance 616/2012

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