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  • 1.  would you use UKRP and UK Importer services in one company

    This message was posted by a user wishing to remain anonymous
    Posted 05-Aug-2021 08:52
    This message was posted by a user wishing to remain anonymous

    or would you split them into one company would be your UKRP  and another UK importer? 


  • 2.  RE: would you use UKRP and UK Importer services in one company

    Posted 05-Aug-2021 10:57
    As this is a new business opportunity I think it's ok but be prepared for some agencies not to survive and the need to replace them. I have it scheduled as a talking point in our Management Review in a few weeks as a regulatory and business risk to the company for UK sales.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 3.  RE: would you use UKRP and UK Importer services in one company

    Posted 05-Aug-2021 14:59
    While this would seem completely acceptable from a regulatory perspective, I will caution that you need to remember that your UKRP must have the necessary qualifications to act within that role.  So to me there will be a very select small number of companies that would be able to handle both roles and help you build your business prospects in the UK as an importer.  To Ed's point - I think you might see some unicorn companies pop up that claim that they can do it all, but I would be careful about whether I used them for both issues.  I likely would pick a strong business partner for the importer and then choose someone with a proven track record as an RP from the EU with an UK office as my UKRP.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


  • 4.  RE: would you use UKRP and UK Importer services in one company

    Posted 06-Aug-2021 08:32
    Yep, I would have to concur with Victor - make sure the entity doing with UK Responsible Person or UK Importer or both are qualified, supportive, and necessary competencies to perform the activities.  And definitely agree with Ed and Victor to conduct your own due diligence in the company because there will be many taking advantage of this "new requirement" and fade away in a year or two after financially padded or realise this is not a good business model.  There is no issue to have both, except from a business perspective as been mentioned.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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