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Regulatory Focus™ > News Articles > Brazil Introduces New Online System for Minor Changes to Package Inserts

Brazil Introduces New Online System for Minor Changes to Package Inserts

Posted 18 March 2013 | By Louise Zornoza

Brazil's National Health Surveillance Agency, Anvisa has announced the creation of a new system for filing petitions for minor changes to package inserts through a new online portal on the agency's website. 

The new system permits companies to notify the agency immediately of any changes to the leaflet and eliminates the waiting time for the agency to review the changes. Companies can implement the changes almost immediately and they will be available to the public within 24 hours after submission to the agency. 

In a statement, Anvisa CEO Dirceu Barbano said the new system speeds up the processing of changes that do not require detailed analysis, allowing the agency to focus on regulatory issues of greater importance. Anvisa plans to update within 30 days the current guidance for the electronic submission of package inserts.

Tags: brazil

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