PharmPK Discussion - Registration of Pharma Products in Brazil

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On 25 Oct 2004 at 04:45:53, vardhini kirthivas (vardhinikirthivas.-at-.yahoo.com) sent the message


Dear all,
Can some one inform me about Registration of Pharma Products in Brazil?
  I am keen in knowing how to get the application forms for Generic drug
submissions and also how long normally do they take to approve a drug
submission.
Regards
Vardhini

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On 25 Oct 2004 at 15:24:22, "vivek kapoor" (viveckkapur.at.rediffmail.com) sent the message


pl find below the link to the brazilian health agency's (ANVISA) site
providing info on generic product registration in brazil.
regards
http://www.anvisa.gov.br/eng/legis/index.htm#3
[A busy weekend * updated PharmPK archives at
http://www.boomer.org/pkin/
                 * a new version of PK on CD at
http://www.boomer.org/CDinfo.html
             and * new versions of Boomer. The Windows version now
matches the Mac OS X version at http://www.boomer.org/
- db]

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On 25 Oct 2004 at 09:01:20, kumar Ganesh (ganaish.-a-.yahoo.com) sent the message


Hi Vardhini,
For registration of drugs in brazil, click on the
following link
http://www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/
135_03re_e.htm
This link will lead to ANVISA site having detail
information regarding the procedure, forms and
documentation for registration.
For Industry legislation, click on the following link.
http://www.anvisa.gov.br/hotsite/genericos/industria/legis_eng.htm
For guidelines on bioequivalence studies, proceed to
the following link.
http://www.anvisa.gov.br/eng/bio/index.htm
Also,please note that the centers conducting
Bioequivalence have to be certified by ANVISA.
Hope this helps.
Regards
Ganesh

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On 25 Oct 2004 at 13:25:01, "Daniel Rossi de Campos" (Daniel.Campos.at.anvisa.gov.br) sent the message


Dear Dr Kirthivas,
Regarding your issue of application forms for Generic drug submission in
Brazil, please try to access the link: www.anvisa.gov.br (National
Health Surveillance Agency) or send your query to this e-mail:
gemeg.aaa.anvisa.gov.br
Regards,
Daniel Rossi de Campos, M.Sc
Pharmacist
Brazil

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