Brazil - New RDC 183 - CBPF (GMP) question

apuigvert

Involved In Discussions
#1
Hello all,

I was informed that ANVISA issued an amendment to the GMP regulation, and I have some doubts about it.

Does anyone know if we should expect a notification from ANVISA requesting additional documents, according to the following article?

Art. 5º - Fica facultado ao estabelecimento fabricante objeto da
certificação enviar diretamente à Anvisa os documentos de que tratam
os incisos VIII a XII do art. 4º, desde que devidamente identificados e
em aditamento ao processo a que se relaciona. Parágrafo único - O prazo
para o protocolo dos documentos de que trata o caput é de até 30 (
trinta) dias após a data do protocolo da petição de certificação.

Does it mean that we have 30 days from the day thet ANVISA issue a request? Or from the day that the new regulation was issued?

Does this requirement apply to the ongoing processes (submitted and under review) or only for new submissions?

When is the deadline to submit the new documents? Thanks!!!!
 
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Marcelo

Inactive Registered Visitor
#2
Re: Brazil- new RDC 183 - CBPF (GMP)

Hello all,

I was informed that ANVISA issued an amendment to the GMP regulation, and I have some doubts about it.
In fact it's an amendment to RDC 39, which defines the requirement for the CMP certificate (not an amendment to the GMP regulation RDC 16).

Does anyone know if we should expect a notification from ANVISA requesting additional documents, according to the following article?

Art. 5º - Fica facultado ao estabelecimento fabricante objeto da
certificação enviar diretamente à Anvisa os documentos de que tratam
os incisos VIII a XII do art. 4º, desde que devidamente identificados e
em aditamento ao processo a que se relaciona. Parágrafo único - O prazo
para o protocolo dos documentos de que trata o caput é de até 30 (
trinta) dias após a data do protocolo da petição de certificação.

Does it mean that we have 30 days from the day thet ANVISA issue a request? Or from the day that the new regulation was issued?
No, this is defined in Art. 14. If you already made the GMP Certificate petition, but the inspection has not been scheduled or performed, you have to send the documents from Art. 4 that were not sent originally and the declaration from Art. 14 II.
ANVISA will not send any request, the petitioner has to perform as required by the new regulation.

The petitioner (Brazilian entity) is responsible for this, however, due to Art.5 , the manufacturer abroad can send the mentioned document directly to ANVISA.



Does this requirement apply to the ongoing processes (submitted and under review) or only for new submissions?
Ongoing, as mentioned above (before scheduling).


When is the deadline to submit the new documents? Thanks!!!!
You have 60 days to do that after the publication of the regulation (as in Art 14 §1º).
 

apuigvert

Involved In Discussions
#4
Re: Brazil- new RDC 183 - CBPF (GMP)

Please help me with the last question. The following item requests the inspection report of the local competent authority. What if the company didn't register the product in its country of origin?

X - cópia de relatório de inspeção ou auditoria mais recente emitido pela autoridade sanitária do país de origem ou por organismo terceiro por ela credenciado;
 

Marcelo

Inactive Registered Visitor
#5
Re: Brazil- new RDC 183 - CBPF (GMP)

Please help me with the last question. The following item requests the inspection report of the local competent authority. What if the company didn't register the product in its country of origin?

X - cópia de relatório de inspeção ou auditoria mais recente emitido pela autoridade sanitária do país de origem ou por organismo terceiro por ela credenciado;
You need to justify why you are not being inspected in your country of origin. In the case that a contract manufacturer of another country is used, you could send their inspection report, if the case.
 

apuigvert

Involved In Discussions
#6
Re: Brazil- new RDC 183 - CBPF (GMP)

Thank you! there is no contract manufacturer, the case is that the local market is not interesting for the commercial department. I think that would be a valid explanation, the products are CE marked so we can send the NB report. Right?
 
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