IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18

 

Inside this issue

     

Revised EU guideline on excipient labelling is adopted

The European Commission issued a new guideline this month for marketing authorization holders (MAHs), giving a list of excipients that should be included on a medicine’s label and the information for them that must appear on the package leaflet.

The final version of the labelling guideline – for which IPEC Europe submitted comments during the revision process – can be viewed on the Commission website here. The EC notes that it does not apply to excipients when they are used as active substances.

According to Directive 2001/83/EC, all excipients in parenteral, ocular and topical medicinal products must appear on the labelling (outer package, or if no outer package on the immediate packaging). It also states that all excipients must be stated on the package leaflet by name.

 

 

 

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