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Regulatory Focus™ > News Articles > Brazil Opens Consultation on API Manufacturing Change Notifications

Brazil Opens Consultation on API Manufacturing Change Notifications

Posted 15 July 2013 | By Louise Zornoza

Brazil's National Agency for Sanitary Surveillance (Anvisa) opened a public consultation (Consultation No. 22/13) on 12 July 2013 concerning new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs).

The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer would have to notify Anvisa of changes according to the impact on the safety of the product. For certain changes, the notification must be made annually, while others require immediate notification to the agency after the changes have been implemented or even before their adoption. 

The deadline for comments is 2 September 2013.

Anvisa Consultation

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