Excipient labelling guidelines need revising, says CHMP
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Excipient labelling guidelines need revising, says CHMP The EMA’s CHMP has recommended that the guideline on excipient warnings in labelling be revised, as it says that several safety concerns regarding excipients have been identified which are not currently addressed in the guideline. The Excipients in the Label and Package Leaflet of Medicinal Products for Human Use guideline was last revised in July 2003. It contains statements relating to the presence of certain excipients that need to be declared on the labelling of medicinal products that are injectable, topical or eye preparations. Concerns have arisen about the fact that the current guideline does not cover the paediatric population or pregnant women. Additional excipients need to be added to the guideline and additional routes of administration need to be considered for some of the excipients. More information is also needed on how to address warnings in the package leaflets, the CHMP says. The committee proposes that a draft revised guideline be released for external consultation between the third quarter of 2013 and the first quarter of 2014. EMA. 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) Draft. Internet Document : [3 pages], 6 Feb 2012. Available from: URL: http:// 803069136 www.ema.europa.eu
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Reactions 14 Apr 2012 No. 1397
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