Regulatory Open Forum

 View Only

  • 1.  Labeler Code & Establishment Registration

    Posted 01-Apr-2020 10:42
    Hi,

    For a company that is headquartered in Canada, who will be the NDA applicant and NDA holder, that also has an establishment in the USA who is the US Agent and will be the Distributor of Drug in the USA, which company name and address should be used when applying for a Labeler Code and Establishment Registration with the FDA?

    Should the Canadian Company (NDA Applicant & Holder) request the Labeler Code and apply for the Establishment Registration? Or should the US establishment (Drug Distributor in USA) request the Labeler Code and apply for the Establishment Registration?

    ​Thank you in advance for your help,
    Jeremy

    ------------------------------
    Jeremy Hanman
    Director, Regulatory Affairs

    ------------------------------


  • 2.  RE: Labeler Code & Establishment Registration

    This message was posted by a user wishing to remain anonymous
    Posted 03-Apr-2020 17:00
      |   view attached
    This message was posted by a user wishing to remain anonymous

    These slides from the SPL team may help....I am a bit confused does the Canadian company owns the USA Agent company? The US agent is your Private Label Distributor. The Canadian company has to have an establish registration because they are responsible for the drug but the PLD does not. 

    This process is difficult. Good luck.

    -Crystal
    Original Message


Related Content