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Regulatory Focus™ > News Articles > Brazilian Good Practices Certification Process Simplified

Brazilian Good Practices Certification Process Simplified

Posted 19 August 2013 | By Ansis Helmanis

Brazil's National Agency for Sanitary Surveillance (Anvisa) published a new resolution (RDC No. 39/2013) on 16 August 2013 that replaces ten previous resolutions with a single administrative standard governing Good Practices Certification (GPC) and the definition of criteria for automatic renewal of such Certificates for medicines and medical devices, as well as cosmetics.  

The new standard simplifies the contents of certificates of Good Manufacturing Practice (GMPs) for Medicinal Products, as well as the possibilities for inclusion of new pharmaceutical forms, supplies or classes of risk in production lines with an existing Certificate.  

It also simplifies the issuance of the Certificate of Good Storage Practices for Medicines and Health Products regardless of joint distribution activity.


Anvisa - RDC No. 39/2013

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Tags: brazil, GMP