Tuesday 26 January 2021

Excipients labelling

The European Medicines Agency (EMA) has updated this guidance relating to excipients labelling. Here Marketing Authorisation (MA) holders and applicants will need to identify the excipients included in any human medicine authorised in the EU in its product information.

The notification states that guidance is available from the European Commission and European EMA on what needs including in the labelling and package leaflet.


See: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/reference-guidelines/excipients-labelling

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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