This message was posted by a user wishing to remain anonymous
As a foreign manufacturer of biological product, to register my product in Brazil, I am looking for someone or some company who can be MAH for our product there.
I have got several recommendations;
"to protect the right of MAH and take any prevention measure, it is better to contract with CRO (who do Regulatory Activities only) than Distributing company", due to the contract issue with distributor can damage the registration (normally they do not agree to transfer the right of MAH to other company). So I have tried to find CRO who has MAH service, but I cannot make it.
Besides, in ANVISA's website it says that distributor cannot register the product. (https://www.gov.br/anvisa/pt-br/acessoainformacao/perguntasfrequentes/administrativo/autorizacao-de-funcionamento-afe-ou-ae/distribuidora-importadora-e-transportadora)
So, I am quite confused.
Why people recommended me to find and contract CRO to register the product and at the same time distributors in Brazil send me a proposal, saying that they can be a MAH in Brazil.
Could I get a recommendation for CRO who has this kind of service? (I contacted to PPD and IQVIA, and they said that they cannot be MAH in Brazil)
To confirm whether a CRO or a distributor can really be MAH in Brazil, which certificate or qualification should be confirmed?(I have checked AFE, but there are quite many categories; Armazenar, Distribuir, Embalar, Expedir, Exportar, Fabricar, etc.) Among them which AFE qualifies for being MAH?)
Thank you so much :)