Dear Mr Harikishan
You can find all information on ANVISA´s procedure at:
http://www.anvisa.gov.br/eng/drugs/registration.htm
The requirements of RDC 138 / 2003 are:
1- The therapeutic group and indication must be
described in GITE (a list of group of
therapeutics and indications), which is in the
RDC 138/2003.
2- You need to prove that the product is
commercialized at least for 5 years in USA or
European community, since approved by FDA or EMEA
3- Present the pharmacovigilance reports (a copy
of those that are sent to local authorities)
4- you need to prove that the product is an OTC
product at the origin country (certificate,
formal documentation)
You can find the complete list of GITE at:
http://www.anvisa.gov.br/eng/legis/resol/138_03_rdc_e.htm
Regards
Maria Ines Harris
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