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  • 1.  US - CMC post-approval change submitted in Annual Report

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jul-2017 09:02
    This message was posted by a user wishing to remain anonymous

    Hi,

    I come from other country and not very familar with US regulation. May I seek your advice on below questions?

    1. for change in manufacturer name only (no change in manufacturing process and product)​, what should be included in annual report? Is artwork required?

    2. if IV bag label artwork is changed (e.g. change in layout), can I submit this change under aunnal report?

    Thank you very much!


  • 2.  RE: US - CMC post-approval change submitted in Annual Report

    Posted 18-Jul-2017 09:27
    ​First one - Annual reportable.
    Second one - Someone from Ad promo regulatory could answer this one. I think it is annual reportable/CBE-0.

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    GRSAOnline
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    Original Message


  • 3.  RE: US - CMC post-approval change submitted in Annual Report

    Posted 18-Jul-2017 09:34
      |   view attached
    Please see attachment, page # 12, section 2 - manufacturing site, that may answer your question # 1.



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    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Attachment(s)

    pdf
    CMC_Post-approval_Annual Report.pdf   105 KB 1 version
    Original Message


  • 4.  RE: US - CMC post-approval change submitted in Annual Report

    Posted 20-Jul-2017 00:25
    ​​Hi,

    1. If it is DS manufacturer name change without any change in process, address and product the impacted sections are 3.2.S.2.1 Manufacturer(s), in case of DP, the impacted section will be 3.2.P.3.1 Manufacturer(s), if any declaration is available it will be part of 3.2.r.    

    Regarding artwork- I believe its not required to include as it doesn't contain manufacturer name instead it contains distributor name.

     
    2. According to section X. D.1 (PAGE # 26) of changes to NDA & ANDA guideline(attached) it is AR.

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    PELALA
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    Original Message


  • 5.  RE: US - CMC post-approval change submitted in Annual Report

    Posted 20-Jul-2017 00:28
      |   view attached
    ​Attached guideline

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    PELALA
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    Attachment(s)

    pdf
    ucm077097.pdf   173 KB 1 version
    Original Message


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