The Brazilian Regulatory Affairs - Things you should know about

Atualizado: 12 de Dez de 2019

Are you a foreign pharmaceutical, or medical device, cosmetic or food company?

Does your company sell through website? Instagram? facebook? WhatsApp? Twitter? or any other kind of social medial?


If you answered "yes" to one or more of this questions this article is for you.


Exactly at this moment your website may be visited by consumers from Brazil. You can probably say this is not your problem, since you do not sell to the Brazilian market.

Well, maybe you are right considering your country rules.


However, according with the Brazilian legislation(specifically federal n. 6.360/76 concerning food and drug law control as well as the Consumer Code) no product can be exposed to the Brazilian market without the National Sanitary Surveillance Agency - ANVISA Approval (article 12).


Thus, this understanding ("exposed to the Brazilian market") is applicable for products controlled by Anvisa and announced through website or other type of social media even when it is not being sold to Brazil.

Moreover, sometimes your company may be only selling the product in your country but your customer by himself resells the goods to the Brazilian market.


The Brazilian jurisprudence nowadays highlights several problems with the health inspection just as well as the Consumer Public Attorney lawsuits arises. Just because the company did not take the necessary measures in its website or social media.


The differences between the foreign legislations and the Brazilian system are significant enough to merit a little forethought and preparation in your social media communication. Do not forget to bring up your regulatory affairs and marketing teams attention to this important issue to avoid any further problem with the Brazilian authorities.


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