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Brazil GMP license work with multiple BRH?

#1
Hello, I have a Brazil GMP license related question. Much appreciated for any input.

Currently we are a foreign manufacturer holding the B-GMP license and also a few dozen IVD products registered by our BRH/local distributor.

I understand that these products are tied to our current BRH and my question is that whether our GMP license is also tied to the same BRH. So in essence my question is if we want to work with another distributor to register other products, do we need a new GMP inspection? or having already obtained the GMP license we are free to work any BRH in Brazil?

Thanks
 
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#2
Hello, I have a Brazil GMP license related question. Much appreciated for any input.

Currently we are a foreign manufacturer holding the B-GMP license and also a few dozen IVD products registered by our BRH/local distributor.

I understand that these products are tied to our current BRH and my question is that whether our GMP license is also tied to the same BRH. So in essence my question is if we want to work with another distributor to register other products, do we need a new GMP inspection? or having already obtained the GMP license we are free to work any BRH in Brazil?

Thanks
The GMP certificate is tied to the BHR, because it is the one that requested it. To use another BHR, you need him to request another license (and ANVISA may or may not do a physical inspection, because if they already did, they may issue the certificate without going there - but the fee must be paid anyway).
 
#3
The GMP certificate is tied to the BHR, because it is the one that requested it. To use another BHR, you need him to request another license (and ANVISA may or may not do a physical inspection, because if they already did, they may issue the certificate without going there - but the fee must be paid anyway).
Much appreciated. Just a clarification, we would need the new BRH to request GMP license and pay the $20000 fee?
 
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