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  • 1.  ANVISA variation guidance

    Posted 27-Sep-2014 02:15
    Dear Forum Members, Does any body know the ANVISA (Brazil) guideline for API variations??? If yes plzz advise the link or guidance. Best Regards, ------------------------------------------- Sushil Sharma Visakhapatnam India -------------------------------------------


  • 2.  RE: ANVISA variation guidance

    Posted 04-Oct-2014 17:32

    Dear Sushil

    In 2009 ANVISA published RDC 57, regulating the registration of API. Normative Instructions 15/09 and 3/13 list the API that need to be registered separately from finished product (drug).

    RDC 57/09 only defines the requisites for registration and renewal of API. It doesn't defines how to proceed in case of variations.

    Nevertheless, RDC 48/09 is the resolution that defines the variations requirements related to drugs (finished product) registrations. There is a chapter defining the requisites for changes related to the API used in the finished product.

    I know it sounds a little confusing. Let me know if you have any specific question,

    Regards

    -------------------------------------------
    ANDRE JOCHEN RAC
    SAO PAULO
    Brazil
    -------------------------------------------


    Original Message


  • 3.  RE: ANVISA variation guidance

    Posted 25-Oct-2014 00:31
    Dear Mr Andre, Many thanks for your information. May I request for your help and Could you kindly send me the below resolution in English translation. It would be of great help to me. My sincere heartfelt thanks to you in advance for your kind help!!! ------------------------------------------- Sushil Sharma Visakhapatnam India -------------------------------------------
    Original Message