Regulatory Focus™ > News Articles > Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types

Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types

Posted 14 May 2012 | By Ansis Helmanis, 

Based on a 7 May agreement between Brazil's National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA), companies will be allowed to produce drugs for both veterinary and human use in the same manufacturing facility as long as the active ingredients and excipients have been approved for both human and veterinary use.

Companies wishing to take advantage of this new approach will be required to obtain Certificates of Good Manufacturing Practices (CBPF) based on the new agreement. 

Anvisa will amend the text of Resolution RDC n the17/2010, which addresses the minimum requirements to be followed for compliance with Good Manufacturing Practice for Medicinal Products for Human Use.


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Anvisa - Anvisa advice on veterinary drugs and human medicines

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Tags: CBPF, MAPA, Veterinary, pharmaceutical, brazil, cGMP, drug, GMP

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