by NHMF
Exported vegetable products shall meet additional sanitary requirements
Last Tuesday (13/Aug/2019), the Brazilian Ministry of Agriculture, Livestock and Supply (MAPA) published the Instrução Normativa nº 19, ruling on requirements, criteria and procedures for the issuance of the International Sanitary Certificate for vegetable products.
According to such ruling, the certificate, which can a digital one, will only be issued if, in addition to compliance the Brazilian laws, the requirements of the importing country or country blocs which were agreed upon or officially informed are observed.
Considering that meeting the qualitative and sanitary requirements is paramount for achieving competitiveness in the international Market, the exporting company shall comply with the new commercialization dynamics and adopt procedures to attest the product conformity.
The Instrução Normativa shall come into force ninety (90) days after is publication.
The Public Law and Regulatory Department of NHM Advogados will keep following up the initiatives for the easing and modernization of the inspection processes in the international trade, and it will be at your service to render any assistance related to the issue.
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.