Regulatory Open Forum

Hi,

We are looking at making drug product submissions in Brazil. It seems the importation requirements are quite stringent. 

Could someone share regulatory requirements for importation into Brazil? Maybe a checklist? Or point out to guidance documents.  

It will help us in proceeding and finalizing our decision to explore this market.

Any and all suggestions will be appreciated.

Thank you for your time.

Regards,

Imtiyaz

The following link will provide some general information on how to import medical products to Brazil subject to ANVISA surveillance. https://www.gov.br/anvisa/pt-br/assuntos/paf/importacao/importacao-de-produtos/informacoes-gerais The main regulation is RDC n 81/2008 https://antigo.anvisa.gov.br/legislacao#/visualizar/28269  the following site contains a checklist in Portuguese https://www.gov.br/pt-br/servicos/obter-anuencia-na-importacao-de-produtos-sujeitos-a-vigilancia-sanitaria Good luck!

Hi,

We are looking at making drug product submissions in Brazil. It seems the importation requirements are quite stringent. 

Could someone share regulatory requirements for importation into Brazil? Maybe a checklist? Or point out to guidance documents.  

It will help us in proceeding and finalizing our decision to explore this market.

Any and all suggestions will be appreciated.

Thank you for your time.

Regards,

Imtiyaz

Hi,

We are looking at making drug product submissions in Brazil. It seems the importation requirements are quite stringent. 

Could someone share regulatory requirements for importation into Brazil? Maybe a checklist? Or point out to guidance documents.  

It will help us in proceeding and finalizing our decision to explore this market.

Any and all suggestions will be appreciated.

Thank you for your time.

Regards,

Imtiyaz

Hi Imtiyaz,

We can support you with drug product submissions and navigating regulatory requirements. Cencora PharmaLex is one of the largest global regulatory solutions providers for Pharma, Biotech, and MedTech companies, with offices in over 60 countries around the globe, including Brazil. We can provide solutions at whatever stage of development or commercialization you're at in the product lifecycle. I'd be happy to discuss your needs further and connect you with the appropriate subject matter experts here at Cencora PharmaLex. Please let me know what the best way to connect with you is, and we can set up a call.

Hi,

We are looking at making drug product submissions in Brazil. It seems the importation requirements are quite stringent. 

Could someone share regulatory requirements for importation into Brazil? Maybe a checklist? Or point out to guidance documents.  

It will help us in proceeding and finalizing our decision to explore this market.

Any and all suggestions will be appreciated.

Thank you for your time.

Regards,

Imtiyaz