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European Coalition on Homeopathic & Anthroposophic Medicinal Products

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Public consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use

21 Mar 2017

The European Commission (DG SANTE) has launched a public consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use (NtA Vol 2C). In 2003, the Commission published a guidance concerning the list of excipients which must be stated on the labelling of medicinal products and the way in which these excipients must be indicated. These guidelines does not apply to excipients when they are used as active substances.

In order to reflect the development since the first publication, the Commission has revised the guidelines and has released them for comments.

The deadline for comments is 22 May. Please send any comments to by 16 April.