Where products for paediatric populations are manufactured in shared facilities with products intended for administration to adults or to animals, do the HBELs need adjustment?

In such facilities the standard body weight value for adults of 50 kg used for calculating the HBEL should be replaced by a lower body weight value (e.g., children: 10 kg, new-borns: 3.5 kg, prematurely born new-borns: 0.5 kg) and used for HBEL determination for all relevant products in order to reflect the worst case situation.

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