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The European Medicines Agency (EMA) has published a new consultation paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use.
The EMA are concerned that their current guidelines in this area do not sufficiently address the paediatric population or pregnant women.
The concept guideline states: “
It is important to note that the safety of excipients can affect children differently than adults due to the ongoing organ development and incomplete maturation depending on the age.”
Regarding pregnant women, the concept guideline says: “
Safety labelling is needed for products intended for use in this population to ensure the safety of the unborn child(ren).”
The EMA also suggest that a revised guideline cover additional routes of administration and excipients, and give more information about how warnings in the package leaflet should be addressed in the summary of product characteristics (SmPC).
Hospital Pharmacists can return their views on EMA’s concept paper by 31 May 2012.