Brazil ANVISA Provides Application Form to Update the Positive List of Technical Product for Equivalent Reference  

On 22 April 2016, the Brazil ANVISA published the “Application Form for the Inclusion or Alteration of Referenced Technical Product” to concerning registrant who wishes to include or modify product into/in the “Positive List of Technical Product for Equivalent Reference”. The list contains the active ingredient, trade name, registration number of the technical products can be appointed as reference product by other applicant who proposed for pesticide registration under equivalence category.

According to Brazilian pesticide regulations, pesticide registration under equivalent technical product and formulated product based on equivalent technical product will have their own procedures and priority sequence. The ANVISA is responsible of informing the applicant of equivalence registration on which registered product can be appointed as referenced product for equivalence determination. The appointed product should contain necessary information studies, data and information for the determination. A technical product can be appointed as referenced product provided it contains all the data for equivalence determination and other requirements even it has been canceled of registration, whereas, a technical product which registered under equivalence category cannot be appointed as referenced product by other applicant.

The “Positive List of Technical Product for Equivalent Reference” is published by ANVISA and latest update was made on 8th Mar 2016. Totally 169 technical products based on 160 active ingredients were included into the list, of which 55 are herbicides, 48 are insecticides, 41 are fungicides, 10 are miticides and 6 are plant growth regulators. The technical products under data protection and registration cancelation are summarized in below table(click on the picture to download in PDF file):

 
Companies interested in inclusion their products into the list or modify their included product should fill the application form and concerning technical justification to the Equivalent Product Administration-GPREQ / GGTOX. The request in other form will not be accepted.

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