Brazilian Good Practices Certification Process Simplified

| 19 August 2013 |  By 

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

Read all Breaking News from RegLink


© 2023 Regulatory Affairs Professionals Society.

Tags: brazil, GMP

Discover more of what matters to you

No taxonomy