IPEC e-newsletter - Excipients Insight June/July 2017 - 10-07-17


Inside this issue


IPECs respond to EC excipient labelling guideline revisions

In May, IPEC Europe and IPEC-Americas submitted comments to the European Commission on its draft revision of the guidelines for excipients in labelling and package leaflets of medicinal products for human use.

Under EU regulations, all excipients must appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging if the medicinal product is an injectable or a topical or eye preparation. The package leaflet must also list the qualitative composition of active substances and excipients. The revised version updates the current version of the guideline, which was published in 2003.

"In general, IPEC is supportive of the proposed amendments to the guidelines and welcomes the clarifications offered on excipients labelling requirements of medicinal products for human use," said IPEC Europe and IPEC-Americas in its submission.

Some of the comments received by the IPEC membership during the review period related to the annex of the guideline which at this point remains unchanged, and these were included in the submission for reference.




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