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  • 1.  Legal Manufacturer change

    Posted 15-May-2018 17:38
    Hi, 

    Who is responsible for  re-registrations due to legal manufacturer change? Receiving  company or delivering?


    Best, 
    Taj

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    Sartaj Kaur-Hurrle
    Carlsbad CA
    United States
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  • 2.  RE: Legal Manufacturer change

    Posted 16-May-2018 05:11
    It should be the receiving company as they will now be considered the Legal Manufacturer.  The question is a bit broad, so I would say it is the receiving company; if you are referring to information in the FURLS database then both companies would have to update their information.  Just assure that you have all the information documented internally.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: Legal Manufacturer change

    Posted 16-May-2018 06:38
    ​Yes this question is too general.
    1. What market  we are talking about - I guess US.
    2. Who did initial registration?
    In my opinion always legal manufacturer is responsible for the products placed on the market. If you sell on other markets, procedure can be more complicated.
    I hope that will help :)
    BR/Kinga

    please see the link: U.S. FDA Registration | Registrar Corp
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    Kinga Kowalska
    Andover MA
    United States
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    Original Message


  • 4.  RE: Legal Manufacturer change

    Posted 19-May-2018 01:01
    You should review the contract and agreement of manufacturer change thoroughly where legal language by the lawyers specify the responsibility and scope of the future events that will be carried out by receiving or delivering entity.

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    Gaurang Bhavsar, MS, RAC
    Manager, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Original Message


  • 5.  RE: Legal Manufacturer change

    This message was posted by a user wishing to remain anonymous
    Posted 21-May-2018 12:13
    This message was posted by a user wishing to remain anonymous

    If you are referring to international registrations and the impact on existing device approvals as a result of a merger or acquisition, then the legal manufacturer is responsible. In my experience, this will impact many international countries as new labeling, new certificates etc will have to be submitted by the new legal mfr as part of the re-registration, in addition to revised contracts/agreements etc that others have already indicated.
    Original Message


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