Updated Guidelines on Product Information File (PIF) for Cosmetic Products

This circular applies to all CCHUHSRR-licensed cosmetic businesses in possession of a valid Certificate of Product Notification (CPN).

Only cosmetic items that have been properly notified and comply with the provisions of the ACD, its Annexes, and Appendices may be placed on the market. Cosmetic goods that are properly registered with the FDA must have a PIF.

The MAH shall make the PIF of a cosmetic product publicly available and accessible to the FDA upon the issuance of a Certificate of Product Notification (CPN).

The MAH must keep the PIF, keep it up-to-date, and take care of it in a way that follows the language, format, and length of time for keeping it set out in these Guidelines.

A PIF audit must be performed on cosmetic goods that have been properly registered with the FDA. The FDA may undertake PIF audits as part of normal inspections and audits, on an ad hoc basis, either on-site or remotely.