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  • 1.  Country Specific Caution Statement On Clinical Trial Label

    Posted 30-Oct-2023 10:48

    Dear community, Is there a harmonized caution statement that can be used on a UK/Canada/US label?  Otherwise can we include the 3 statements on the label?  Thanks!

    UK: For Clinical Trial Use Only.  Canada: Investigational Drug - To be used by qualified investigators only  US:  New drug - limited by Federal or US law to investigational use.



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    Jean Schaefer
    Niantic CT
    United States
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  • 2.  RE: Country Specific Caution Statement On Clinical Trial Label

    Posted 31-Oct-2023 09:00

    Hi Jean,

    I have not seen a harmonized statement. Since 21 CFR 312.6 states that the drug "shall bear a label with the statement" (my emphasis) it would be a violation of the regulation not to include that statement for the US. If the label is large enough to include all 3 statements, I wouldn't see any reason not to include it, but most of the labels I have seen are not large enough for all three.



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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    Burien WA
    United States
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    Original Message


  • 3.  RE: Country Specific Caution Statement On Clinical Trial Label

    Posted 01-Nov-2023 12:13

    I have included multiple clinical investigation statements on one label before without any issues. Please keep in mind that for Canada, you'll need to provide this statement in both English and French. 



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    Jennifer Cabralda RAC
    Director, Regulatory Affairs
    Coquitlam BC
    Canada
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    Original Message


  • 4.  RE: Country Specific Caution Statement On Clinical Trial Label

    Posted 02-Nov-2023 05:06

    Hi Jean,

    Normally you have different labels for different countries. This is what all other manufacturers are doing. As Glen mentioned - there is no harmonised statement, you just need to follow the local laws. 

    Make sure you have this statement because otherwise the authorities will ask you to update the label which will cost you more than having the correct label in a first place.

    Have a great day.

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
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    Original Message


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