Regulatory Open Forum

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  • 1.  MA transfer in Asia

    Posted 11-Oct-2018 14:51

    Assume that we have a license partner in Asia and the product manufactured by us is marketed by the Asian partner.

    If we terminate the contract with the Asian partner before transferring the MA to a new partner, and then find the new partner later, what will happen to the MA?

    Should we submit the new MAA via the new partner as "generic"?

     

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  • 2.  RE: MA transfer in Asia

    Posted 20-Oct-2018 08:43
    Hello,

    There are 2 scenarios:

    1. In Ideal situation to retain your MA in Asia, you need to first transfer your MA to the new partner and in several Asian countries, it requires Letter of transfer rights from your existing partner.

    2.In worst case scenario, if your existing partner is not co-operating then you might have to search for a new partner first but here there is a risk of loosing the MA and you may have to apply for a new MA.

    The MA Transfer process in most of the Asian countries are well defined and are part of variation guidelines.

    Good Luck !

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    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
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