Regulatory Focus™ > News Articles > EMA Releases Concept Paper on Excipient Labeling

EMA Releases Concept Paper on Excipient Labeling

Posted 08 March 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a concept paper on 8 March about the need to revise current labeling guidelines for medicines containing excipients.

Current guidelines contain warnings about the presence of certain excipients, particularly those pursuant to 2001/83/EC Article 54(d) which states that all excipients must be declared if a product is an injectable product or eye preparation. Further, all excipients know to have an action or effect on the body must be declared.

The concept paper notes the need to expand beyond this limited labeling regulation to encompass additional products, information and populations, including pediatric populations, pregnant women and additional routes of product administration.

EMA recommends that the current guideline be revised to take these considerations into account.

Read more:

Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00)


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