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National phase labeling queries

  • 1.  National phase labeling queries

    This message was posted by a user wishing to remain anonymous
    Posted 6 days ago
    This message was posted by a user wishing to remain anonymous

    Hello everyone

    I have received the below queries after EOP, during national phase review of my product registration submission, from Belgium HA. Does anyone know what is 'PAC mockup' and what is to be submitted in the below queries? FYI, we do not have a distributor at the moment.

    1. Mock-up package or a PAC Mockup (in case no Mockup available) even if the product will not be marketed 

     

    1. Delegation of power (if needed)

     

    1. PAC Distributor ( in case no distributor available)