In the interest of service, the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) informs all concerned stakeholders that the processing of all filed and/or issued paid applications for License to Operate (LTO) during the implementation of Administrative Order No. 2019-0007, shall initiate once FDA Circular No. 2021-016, otherwise known as “Licensing Guidelines for Vapor Product and Heated Tobacco Product Establishments under the CCHUHSRR,” is published and has taken effect.
Due to changes in the licensing process and requirements, all concerned stakeholders are requested to submit a new LTO application through the FDA e-portal system (https://eportal2.fda.gov.ph/) and submit the proof of payment of the previous LTO application, indicate in the file name the previous case number, together with the documentary requirements prescribed under FDA Circular No. 2021-016.
LTO applications shall undergo a pre-assessment process. Once passed the pre-assessment process, the previously paid fees shall be deducted accordingly and a new assessment slip reflecting the re-computed application fee shall be sent separately via email. After payment and confirmation of the appropriate fees, the application shall be evaluated and processed accordingly.
For any concerns or inquiries, kindly contact CCHUHSRR through email at [email protected].
For your information and guidance.