New EU Regulation on Postmarketing Surveillance of Cosmetic Products

Regulatory Focus
February, 2014
By Darshan Bhatt

The new EU Cosmetics Regulation has extended the scope of cosmetic product requirements to include postmarketing surveillance and reporting of SUEs. The regulations require an Responsible Person (RP) to be designated prior to marketing a cosmetic product and throughout its lifecycle. Companies must be aware of differences in minimum information, causality assessment and reporting requirements from those of medicinal products. Efficient planning and training for the new regulation cannot only facilitate product launches but also prevent compliance issues and help to keep cosmetics on the market.

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