Brazilian Regulators Propose Switching From Paper to Electronic Permit Submissions

Posted 17 June 2013 | By Louise Zornoza 

Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation (20/2013) regarding its proposal to switch from paper-only to e-format-only submissions for Operating Permits (AFE) and Special Authorizations (EA), documents that are necessary for any company that has Anvisa-regulated products such as medicines.

The proposal also would:

  • establish automatic renewal of AFEs and EAs
  • harmonize the technical requirements that must be met by companies
  • determine what should be verified by local health authorities. 

Currently, there are 27 rules for granting, amending, renewing and cancelling such permits, and the proposal intends to consolidate the rules and make the process more transparent.  The deadline for comments is early August 2013.

ANVISA Consultation

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Tags: AE, brazil

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