Brazil - Submitting Technical Files

jiligan

Involved In Discussions
#1
We are currently setting up an agreement with a company to be our registration holder in Brazil. However, we do not want to release the technical files to them and have been told that we can submit all registration information to the BRH other than the technical files, we would submit the tech files directly to ANVISA for their review. Has anyone registered their products in Brazil working with the BRH but submitting technical files directly to ANVISA? Is it possible to get a confidentiality agreement with ANVISA for the review of the technical files? Thanks!
 
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Marcelo

Inactive Registered Visitor
#2
The Brazilian Registration Holder is formally (technically and legally) responsible for the product in Brazil, and is the one that performs the submission. He will submit all the information, including the technical file - this is in the case of Registro, classes III and IV. For cadastro, the technical file is not sent to ANVISA, but it has to be created and maintained by the BHR. Some do not keep this (maybe that's what you meant), but this does not fulfill the requirement.

Also, as the BRH will perform the submission, the manufacturar cannot get a confidentiality agreement with ANVISA for the review of the technical file.
 

jiligan

Involved In Discussions
#3
The Brazilian Registration Holder is formally (technically and legally) responsible for the product in Brazil, and is the one that performs the submission. He will submit all the information, including the technical file - this is in the case of Registro, classes III and IV. For cadastro, the technical file is not sent to ANVISA, but it has to be created and maintained by the BHR. Some do not keep this (maybe that's what you meant), but this does not fulfill the requirement.

Also, as the BRH will perform the submission, the manufacturar cannot get a confidentiality agreement with ANVISA for the review of the technical file.
Thank you Marcelo for the information!
 
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