With the on-going updates to the application systems for the issuance of authorizations, including the Food and Drug Administration (FDA) e-Portal system housing the procedure for the electronic notification of cosmetic products (Cosmetic e-Notification v2.0), the FDA hereby provides the following guidance and advice in relation to the revalidation of Certificates of Product Notification (CPNs):
1. Applicants are reminded to check the expiration date of issued Certificate of Product Notification (CPN) prior to filing of revalidation applications. Revalidation applications may only be submitted on or before the validity date of the CPN. Applicants must also pay the corresponding fee on or before the validity date to avail of revalidation.
2. Applicants intending to revalidate expired CPNs are advised to practice due diligence and correspondingly file a new CPN application after the expiration date of their CPN. Applicants are further advised to review the listed undertakings which are accepted by an MAH for every notification application filed through the FDA e-Portal system.
3. It is reiterated that, following Section IV, Item no. 4 of FDA Memorandum Circular No. 2015-011, there must be no modifications whatsoever to the information submitted in the original CPN in order to be eligible for revalidation. MAHs are advised to refer to the updates and amendments to the ASEAN Cosmetic Directive (ACD) Ingredient Annexes published regularly through the FDA webpage and review the previously declared ingredient listing prior to actual filing of revalidation. Any changes to the information shall constitute a new CPN application.
4. MAHs shall keep an updated Product Information File (PIF) for cosmetic products with acknowledged and revalidated CPNs. Such copies of the revalidated CPNs shall be filed along with the original CPNs in Part I, Item 1.1.3 of the PIF, in accordance with FDA Circular No. 2023-001.
5. Notwithstanding the acknowledgement or decision made on the original CPN, the FDA may require further clarifications and undertake necessary regulatory action to assess the eligibility of an application to be subjected to the notification and revalidation process. Hence, an initially issued CPN is not an assurance of acknowledgment of the notification revalidation application.
6. In circumstances which inadvertently continue unqualified revalidation applications, applicants are advised to contact [email protected].
Marketing authorization holders are also reminded to ensure their products’ continuous compliance with updated rules, regulations and standards. Among others, violations to any of the terms and conditions of the authorization, including the declaration of undertaking specified in the CPN application, are grounds for the disapproval of an application and suspension or cancellation of the authorization.
In parallel with the ongoing update of the FDA e-Portal system, stakeholders are also informed that FDA Memorandum Circular No. 2015-011 “Guidelines for Electronic Notification of Cosmetic Products (Cosmetic E-Notification Version 2.0)” is similarly being reviewed. Updates, including future consultations, shall be posted through the FDA website.
Dissemination of this advisory to all concerned is hereby requested.