IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17


Inside this issue


EMA adds new excipients to labeling requirements

As this edition went to press, the European Medicines Agency (EMA) and the European Commission updated the annex to the Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use.

The updated annex, which contains all excipients that must be declared in a medicine’s labelling and package leaflet and their agreed safety warnings, includes five new excipients as well as new safety warnings for ten existing excipients.

"The main aim of this update is to take into account safety concerns which are not currently addressed in the existing annex to the guideline," said the EMA in a statement. "It also pays specific attention to, for example, the safety of these excipients when used in children or pregnant women."

The updated annex takes account of the comments received for each excipient during public consultations, it continues. The additions and updates apply to: aspartame; benzalkonium chloride; benzoic acid (E120 and benzoates); benzyl alcohol;  boric acid (and borates); cyclodextrins; fragrances containng allergens; fructose; phenylalanine; phosphate buffers; propylene glycol (E1520) and esters of propylene glycol; sodium; Sodium laurilsulfate (E487); sorbitol (E420); and wheat starch (containing gluten).




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