Would ANVISA (Brazil) inspect our new manufacturing site?

Marcelo

Inactive Registered Visitor
#11
This means we have to submit again for the Anvisa GMP and the product registration, stopping shipment to Brazil until received the new registration?
Or we are allowed to make the change and just inform Anvisa?
You would need to submit a new inspection petition for the "new" manufacturing premises, and you would not be able to ship to Brazil until revving the inspection (in this case you do not need a new registration).

Please note that this is the rule, but I?ve seen a lot of instances where people kept shipping. Not my suggestion, thought, because it would be against the law and if you get caught you would be in trouble.
 
Last edited:
Elsmar Forum Sponsor
K

karen12

#12
Our company notified ANVISA regarding the address change and they informed us to get GMP inspection for renewal in new site since the validation date for the certificate is Jan. 2015. After the notification to ANVISA, we're shipping under our new address now. We are expecting to get inspection sooner or later.
 

max.polix

Involved In Discussions
#13
Did ANVISA replied to your notification in written?
Did they express any approval of start shipping production from the new manufacturing address?
 
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