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Measure speeds exports to Mercosur countries

  • Writer Priscilla Viana Palhano Lima
  • Date 2019-11-25
  • Views 3,076

Anvisa defines new flow for Good Manufacturing Practices (GMP) report exchange and, thus, reduces time for export release



Good Manufacturing Practices (GMP) inspection report requests for the marketing of health products in Mercosur can now be made directly to Anvisa. The request must be registered by the Solicita system, a technological solution that allows the procedure to be performed electronically, making the process more agile.


For this, a specific code was created to fulfill the orders, which is 70570 - Request to send inspection report for export purposes to Mercosur.


The purpose of the new flow is to make reporting exchanges more efficient between regulatory agencies in the economic bloc. The measure also aims to make exports of Brazilian products more agile to other Mercosur countries, stimulating business and domestic industry.


As it was before

Prior to the adoption of the new measure, the exporter based in Brazil had to first file a request with the health authority of the neighboring country for the foreign agency to make the request to Anvisa. The procedure required this rite and initial filing in the country to which the export was intended.


As a result, the average process time was long, taking one to two years. The adoption of the new flow will reduce this deadline to a maximum of eight months.


Need

The exchange of GMP inspection reports is necessary for Brazilian companies to export their products to neighboring countries, as provided for in the Mercosur / GMC / RES agreement. 32/2012, internalized through the Resolution of the Collegiate Board (RDC) 22/2013. However, there was a delay in this process.


In the first half of this year, the Brazilian Association of Medical, Dental, Hospital and Laboratory Articles and Equipment Industry (Abimo) presented to Anvisa the difficulties encountered in the flow adopted to exchange these reports, so that improvements could be studied and proposed. The demand was addressed to the General Sanitary Inspection and Inspection Management (GGFIS).


After discussing the issue, GGFIS Health Product Inspection and Inspection Management (Gipro) came up with a model and, in partnership with Abimo, presented the new flow to the regulated sector at a meeting held on 15 September October in São Paulo.


For Anvisa, the approval and implementation of the new flow for health products GMP reports reflects the Agency's commitment to make improvements in work processes in order to fulfill its role of protecting and promoting population health in an agile manner. and efficient.


Read more:


Mercosur Resolution 32/2012 - Common Procedures for Inspections of Manufacturers of Medical Devices and Diagnostic Products for In Vitro Use in States Parties.

Collegiate Board Resolution (RDC) 22/2013 - Approves common procedures for inspections of medical device manufacturers and in vitro diagnostic products manufacturers in States Parties.



Source: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&p_p_col_id=column-2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=medida-agiliza-exportacoes-para-paises-do-mercosul&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=5691313&_101_INSTANCE_FXrpx9qY7FbU_type=content

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