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  • 1.  Hong Kong - Legal Manufacturer Change

    Posted 07-Aug-2013 11:26
    Hello Hong Kong Experts,

    I need your assistance.  I am having trouble locating the steps required to make a legal manufacturer change in Hong Kong.  There does not appear to be any forms on the Health Authority's website for this type of change. Will a written letter from the current legal manufacturer be enough to make this change?  Or do we need to do a whole new Application, which will note both the Legal Manufacturer and Local Responsible Person? 

    Thank you for your assistance.


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    Tanya Lane-Pringle
    Regulatory Clinical Coordinator
    Bioventus LLC
    Durham NC
    United States
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  • 2.  RE:Hong Kong - Legal Manufacturer Change

    Posted 08-Aug-2013 08:25
    Hello Tanya,

    The information that I have been provided by our Distributor to support a change in the name and address of the manufacturer is the following:

                    1. Certified true copy of the manufacturer's Good Manufacturing Practices (GMP) Certificate

                    2. Original or certified true copy of free sale certificate of the product issued by country of origin, (for change of country of origin only)

                    3. Printed new label,or prototype label ready for printing

                    4. Proposed label with change(s) underlined or highlighted

                    5. Letter issued by the current manufacturer to acknowledge the change to the new manufacturer

                    6. Updated master formula issued by the new manufacturer

                    7. Updated specifications issued by the new manufacturer.

    Note: for addition of new source(s): new application(s) for registration is required.

     Application 9 months in advance is needed for this change, but we can apply ahead of FDA approval and specify the expected time for change.

    This type of change would be filed as a "Change in Particulars" application.  Approval would be required prior to selling the 'new' product.

    Hope this helps!

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    Jennifer Timmerman
    Director of Regulatory Affairs
    Kedrion Biopharma Inc
    Fort Lee, NJ
    United States
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    Original Message


  • 3.  RE:Hong Kong - Legal Manufacturer Change

    Posted 08-Aug-2013 16:07

    Dear Tanya,

    Two cases might apply depending what he is asking:

    Case (1) If the manufacturer is an overseas manufacturer of an approved listing product in HK, then you will need the current LRP and product License holder to write to the MDCO in letter form to apply for a change in the manufacturer and submit supporting document of manufacturer, GMP and free sale certificate etc. This assumes that the product has no change in technical or clinical details. Any changes other than administrative changes will demand a new product listing application.

    Case (2) If it is a local manufacturer, the you are right that there is no issued procedure of making changes for Local Manufacturers. Depending on the things that have been changed, you would be required to make a fresh application mentioning reference to the old approved listing product and manufacturer. 



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    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda MD
    United States
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    Original Message