Nutrition products Serious case reporting

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  • #11343

    I deal with adverse events, complaints and medical enquiry related to IFCN/Nutrition products. Therefore, I wanted some information what are the requirements for reporting serious adverse events related to IFCN/Nutrition products. who should we report it and the timelines?

    Any legislation or guidelines would be really helpful.

    Thanks

    #11351

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.  

    Dear Member,

    Thank you for your enquiry regarding adverse events, complaints and medical enquiries relating to IFCN products.

    As per the FDA’s Code of Federal Regulations, when there is a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death, the manufacturer shall, within 15 days of receiving such information, conduct an investigation and notify the Agency as required in 106.150.

    In the UK, although there is no formal system for reporting adverse reactions to non-prescribed nutritional supplements in the UK, if the supplement(s) have been prescribed by their doctor then, it does need to be reported via the MHRA’s yellow card system.

    Please find below some resources which may be of help you:

    Resources:

     

    Kindest regards

    PIPA

    #12261

    Hi,

     

    Thanks for the response.

    What I gather from the above is that we just submit the serious case related to Nutrition product to the MHRA on yellow card system (Reporting timeline 15days?) and also there is no form need to be filled in?

    thanks

    #12289

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.  

    Dear Member,

    Thank you for your follow-up inquiry.

    In this instance, we would advise you to contact the Nutrition Legislation Team for further confirmation and guidance, they can also be reached using the below contact details.

    Tel: 020 7210 4850
    E-mail: nutritionlegislation@dhsc.gov.uk

    Kind regards

    PIPA

    #12297

    Thank you

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