Reply To: Nutrition products Serious case reporting

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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