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[RegAffairs]Re: ANVISA - OTC Registration Requirements
Hy Harikishan Sorry for taking so long time to answer: I got really busy these months 1) YES 2) If you are not marketing it yet, perhaps it will not be accepted as an OTC. You will need to prove to the authorities that although it is a new product, if can be regarded as an OTC because of the active, formulation, present a risk evaluation, etc 3) please, try http://www.anvisa.gov.br/eng/index.htm regards Maria Ines Harris |
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