Regulatory Open Forum

 View Only
  • 1.  Merger and legal manufacturer

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2020 09:07
    This message was posted by a user wishing to remain anonymous

    Hi,

    Needed advice on the below scenario where :

    Company A  is taken over by Company B
     Company B has taken over  all products (X) except Y which remains with Company A .
    So going forward what are the best options for managing these products (all manufactured by Company A )

    Do Certifications for X and Y products , need to be separated for the 2 entities?
    Can Company B remain as the legal manufacturer for both the product groups? What are the repercussions ?
    If Company A becomes the legal manufacturer for Y , what are things that need to be considered.

    Whats the best possible approach?

    Is there any other scenario possible?

    Thanks,


  • 2.  RE: Merger and legal manufacturer

    Posted 28-Jan-2020 04:27
    Interesting scenarios when companies buy other companies.  This can be quite complicated with your description having good information - but there can also be a lot of intricacies involved especially depending on the relationship Company A and B have after the merger/separation.

    To answer your question:
    Separation of certificates: Yes, potentially depending who is going to be the legal manufacturer for the products
    Company B for both: Yes, possible in that case more than likely Company A would be a Contract Manufacturer though depends on the selling of the finished device
    Company A manufacturer: They would be completely responsible as the legal manufacturer including all regulatory aspects

    There probably is not one best possible approach it really depends on the relationship of Company A and B after, how finished devices are going to be sold, and yes there could be some other scenarios, though again depends on the relationship of the companies and how product is going to be placed on the market.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 3.  RE: Merger and legal manufacturer

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2020 09:03
    This message was posted by a user wishing to remain anonymous

    Richard, thanks for your inputs..
    Just a correction 'So going forward what are the best options for managing these products (all manufactured by Company A ) , please read as Company B. Do you think the answer is yes for the 3 questions?