by NHMF
Pharmaceutical manufacturers must comply with new sanitary guidelines
On Tuesday (08/20/2019) the Board of Directors of the National Health Surveillance Agency (ANVISA) approved the new regulatory framework for Good Manufacturing Practice (GMP) of medicines in Brazil.
The new rules will meet international standards to ensure the quality, effectiveness and safety of medicines, enabling the increased competitiveness of national companies and expansion of products exportation to international markets.
Furthermore, from this update, it is expected that Brazil will be integrated to the international inspection cooperation scheme that takes place between countries and pharmaceutical inspection authorities, called Pharmaceutical Inspection Co-operation Scheme (PIC/s).
The Collegiate Board Resolution No. 17/2010 and other related Normative Instructions will soon be updated by the authority and published in the Brazilian Official Gazette.
Our Public and Regulatory Law sector will continue to monitor legislative developments and is available to provide further information or clarification related to the matter.