Search results
LTO
- Any company selling products that may be classified under the control of the Food and Drug Authority (FDA) Philippines will need to secure an LTO from the FDA. Getting an LTO is a prerequisite for successfully securing a Certificate of Product Registration (CPR) for your product from the FDA.
People also ask
Do you need an LTO in the Philippines?
What is the FDA eSERVICES portal?
How do I apply for an FDA LTO?
Is the FDA application process moving online?
Jan 13, 2020 · License to Operate Requirements. Steps for FDA LTO Application. Tips to make application easier and faster. What is an LTO or License to Operate? Why would you need one? An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices.
Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA) Checklist Requirements for Variation Application (License to Operate for Food Establishments)
FDA Circular No.2021-012 || Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Food Traders and Food Distributors Including Wholesalers, Importers, and Exporters of Processed Food Products, Food Supplements, Bottled Water, and Iodized Salt.
Welcome to FDA Verification Portal. This online portal provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/NN) respectively.
Requirements for Initial Application (License to Operate for Food Establishments) Reference: Administrative Order 2020-017 “Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA Repealing AO no. 2016-003” Initial LTO Requirements: Application Form .
- 411KB
- 1
Guideline for the Use of the FDA eServices Portal System for License to Operate (LTO) Application of Drug Distributors, Drug Traders, Drugstores, Retail Outlet for Non-Prescription Drugs (RONPD), Clinical Research Organizations (CROs), and Sponsors. 16 October 2020: FDA Advisory No. 2021-0697: Nationwide
Procedure to Get a FDA LTO (License to Operate): Visit the FDA portal at https://www.fda.gov.ph. Navigate to “New Case” in the upper left-hand corner and choose “License to Operate v2.0” under Electronic Licensing. Go to the General Information tab, and select your Product Type, Primary Activity, and Type of Application from the drop-down menu.