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Regulatory Focus™ > News Articles > Brazil: New Rules For Excipients Published

Brazil: New Rules For Excipients Published

Posted 30 April 2012 | By Ansis Helmanis

The Board of Directors for Brazil's national regulatory agency, ANVISA, agreed on 24 April to the publication of a proposed new regulation for the Certificate of Good Manufacturing Practices for Pharmaceutical Excipients.

Once published in the Official Gazette (DOU), the proposal will be open for comment for 60 days. 

The excipient proposal will test a new system that will permit comments to be filed electronically using a program developed by the Ministry of Health known as FormSus. The system will be maintained by Datasus and is intended to serve as a basis for research on health.

Read more:

ANVISA - Certificate of Good Manufacturing Practices

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