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Regulatory Focus™ > News Articles > Brazil: Updates to Biologics Regulations Proposed

Brazil: Updates to Biologics Regulations Proposed

Posted 09 July 2012 | By Ansis Helmanis

Brazil's National Health Surveillance Agency (Anvisa) has opened a public consultation on proposed amendments (41/2012) to the regulation of biological products in Brazil. 

The proposed changes, released 4 July 2012, address post-registration revisions and additions, the suspension and reactivation of registration and the cancellation of registration of biological products. A second proposal (42/2012) updates RDC Resolution 50/20, which sets forth the procedures and conditions for studies of stability for the registration or post-registration changes of biologicals.


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