How to Register a Food/Drug/Cosmetic Establishment
Establishment registration is a fundamental requirement under the Philippine Food and Drug Administration (FDA) licensing framework. Before any establishment can legally manufacture, import, export, distribute, wholesale, retail, repack, or trade FDA-regulated health products, it must first be registered with the FDA and obtain a License to Operate (LTO). The registration process ensures that facilities meet Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and other applicable quality standards to protect public health and safety. This guide walks you through the complete process of registering your food, drug, cosmetic, medical device, or other health product establishment with the Philippine FDA.
Under Republic Act No. 9711 (FDA Act of 2009) and its Implementing Rules and Regulations, all establishments engaged in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of health products must secure an LTO from the FDA. The LTO serves as proof that your establishment has been inspected, evaluated, and found compliant with the applicable standards and regulations. Operating without a valid LTO is a violation of the law and may result in penalties, product seizure, and criminal prosecution.
Types of Establishments That Must Register
The following types of establishments are required to register with the FDA and obtain a License to Operate before commencing business operations involving FDA-regulated health products:
- Manufacturer — An establishment that processes raw materials into finished health products through various production activities including compounding, formulating, filling, packaging, and labeling
- Importer — An establishment that brings in health products from foreign countries into the Philippines for sale, distribution, or further processing
- Exporter — An establishment that ships domestically manufactured or sourced health products to other countries
- Distributor — An establishment that stores, transports, and delivers health products from manufacturers or importers to wholesalers, retailers, or end users
- Wholesaler — An establishment that sells health products in bulk quantities to other businesses such as retailers, hospitals, and institutions
- Retailer — An establishment that sells health products directly to individual consumers, including pharmacies, drugstores, and grocery stores
- Repacker/Relabeler — An establishment that repackages health products from bulk containers into smaller units or changes the product labeling for distribution
- Trader — An establishment that buys and sells health products but does not take physical possession of the goods, acting as an intermediary between manufacturers/importers and buyers
⚠ GMP/GDP Compliance is Mandatory
All establishments applying for an FDA License to Operate must demonstrate compliance with the applicable Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) standards. The FDA conducts facility inspections as part of the licensing process to verify that your establishment meets the required quality and safety standards. Failure to comply with GMP/GDP requirements will result in the denial of your LTO application.
For manufacturers, the FDA inspection covers facility design, equipment qualification, sanitation and hygiene programs, production controls, quality assurance systems, storage conditions, personnel qualifications, documentation and record-keeping, and waste management. For distributors and traders, GDP compliance covers proper storage, handling, transportation, and documentation of health products. The FDA may conduct unannounced surveillance inspections at any time after the LTO is issued to ensure continued compliance.
Establishment Types and Requirements
The table below outlines the different establishment types regulated by the FDA, along with their descriptions, applicable GMP/GDP requirements, and the expected inspection frequency. Understanding your establishment type is critical for determining the correct application process and documentary requirements.
| Establishment Type | Description | GMP/GDP Requirement | Inspection Frequency |
|---|---|---|---|
| Manufacturer | Produces finished health products from raw materials through compounding, formulation, filling, packaging, and labeling operations | GMP (HACCP for food, PIC/S GMP for drugs, ASEAN GMP for cosmetics, ISO 13485 for medical devices) | Every 1-2 years or as needed |
| Importer | Brings health products from foreign sources into the Philippines for commercial sale and distribution | GDP for storage and handling; GMP certificate from country of origin required for imported products | Every 2-3 years |
| Exporter | Ships Philippine-manufactured or sourced health products to foreign countries and international markets | GMP/GDP depending on activities; Certificate of Free Sale may be required by destination country | Every 2-3 years |
| Distributor | Stores, transports, and delivers health products from source to various sales points and end users | GDP for proper storage, handling, and transportation of health products | Every 2-3 years |
| Wholesaler | Sells health products in bulk quantities to retailers, hospitals, clinics, and institutional buyers | GDP for proper storage and handling; must maintain traceability records | Every 2-3 years |
| Retailer | Sells health products directly to individual consumers (pharmacies, drugstores, grocery stores, sari-sari stores for certain products) | Good Storage Practice (GSP); pharmacies require additional pharmacist supervision requirements | Every 3-5 years or complaint-based |
| Repacker/Relabeler | Repackages products from bulk into smaller consumer units or changes labeling for market distribution | GMP for repacking operations; must ensure product integrity and proper labeling compliance | Every 1-2 years |
| Trader | Acts as intermediary buying and selling health products without taking physical possession of the goods | GDP documentation requirements; must maintain proper transaction and traceability records | Every 3-5 years or as needed |
Note: Some establishments may fall under multiple categories (e.g., a manufacturer that also acts as a distributor and exporter). In such cases, the LTO application must cover all applicable establishment activities, and the facility must comply with the highest applicable GMP/GDP standard for each activity.
GMP Standards by Product Category
Different product categories are governed by specific GMP standards. The FDA requires manufacturers to comply with the applicable GMP framework based on the type of health products they produce. Below is a summary of the GMP standards for each major product category:
| Product Category | Applicable GMP Standard | Key Requirements |
|---|---|---|
| Food Products | HACCP (Hazard Analysis and Critical Control Points) / Food GMP based on Codex Alimentarius | Hazard analysis plan, critical control points identification, monitoring procedures, corrective actions, verification procedures, record-keeping, sanitation standard operating procedures (SSOP), allergen management, pest control program |
| Drugs & Medicines | PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice) | Quality management system, personnel qualifications and training, premises and equipment qualification, documentation system, production controls, quality control laboratory, contract manufacturing and analysis, complaints and product recall procedures, self-inspection program |
| Cosmetics | ASEAN Cosmetic GMP (based on ISO 22716 Guidelines on Good Manufacturing Practices for Cosmetics) | Personnel hygiene and training, premises design and maintenance, equipment qualification, raw material control, production operations, finished product quality control, documentation and record-keeping, internal audit program, waste management |
| Medical Devices | ISO 13485 (Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes) | Quality management system, management responsibility, resource management, product realization, design and development controls, purchasing controls, production and service provision, monitoring and measurement, risk management (ISO 14971) |
Important: The Philippines, as a member state of ASEAN, follows the ASEAN Harmonized Standards for health product regulation. Manufacturers exporting to other ASEAN countries must ensure their GMP compliance is aligned with the ASEAN Common Technical Requirements (ACTR) for mutual recognition of GMP certificates.
Step-by-Step Establishment Registration Process
Follow these seven steps to register your establishment with the Philippine FDA and obtain your License to Operate. The process involves facility preparation, documentary requirements, online application, fee payment, and FDA inspection.
Determine Establishment Type and Activity
Before starting the registration process, clearly identify your establishment type and the specific activities you will be conducting. The FDA classifies establishments based on their primary activity — manufacturing, importing, exporting, distributing, wholesaling, retailing, repacking/relabeling, or trading. Your establishment type determines the applicable GMP/GDP standards, documentary requirements, and processing fees.
Key considerations:
- Identify the specific product categories you will handle (food, drugs, cosmetics, medical devices, household hazardous substances)
- Determine all activities your establishment will perform (some establishments have multiple activities)
- Check if your product category requires specific technical personnel (e.g., pharmacist for drug establishments, food technologist for food manufacturers)
- Verify whether your proposed location complies with local zoning ordinances for your type of establishment
Ensure Facility Compliance (GMP/GDP)
Before applying for an LTO, your facility must be fully compliant with the applicable GMP or GDP standards. This means your facility design, layout, equipment, sanitation programs, and operational procedures must all meet the FDA requirements. Investing in proper facility preparation upfront will save you from costly delays caused by inspection failures.
Facility compliance checklist:
- Adequate floor space with proper layout separating raw materials, production, packaging, and finished goods areas
- Proper ventilation, lighting, temperature control, and humidity control as required for your product type
- Clean and sanitary facility with washable walls, floors, and ceilings in production areas
- Qualified and calibrated equipment for production, testing, and quality control operations
- Adequate water supply meeting potable water standards for food and pharmaceutical manufacturing
- Proper waste disposal system and pest control program in place
- Separate storage areas for raw materials, packaging materials, finished goods, rejected materials, and recalled products
- Personnel facilities including changing rooms, handwashing stations, and protective clothing
Prepare Documentary Requirements
Gather all required documents before filing your application. Incomplete submissions will cause delays in the processing of your LTO. The specific requirements vary depending on your establishment type and product category, but there are common documents required for all applicants.
Common documentary requirements:
- Duly accomplished FDA application form (available online via FDA eServices)
- SEC/DTI/CDA registration certificate of the business entity
- Mayor's Permit or Business Permit from the local government unit (LGU)
- Detailed floor plan of the establishment showing layout of all areas
- List of equipment with specifications and calibration records
- List of products to be manufactured, imported, or distributed
- Organizational chart with qualifications of key personnel
- Standard Operating Procedures (SOP) manual covering all critical operations
- Quality Manual documenting the quality management system
- Proof of engagement of required technical personnel (e.g., licensed pharmacist, food technologist, chemist)
Submit Application via FDA eServices
The FDA uses an online application system called FDA eServices for all licensing transactions. You must create an account on the FDA eServices portal and submit your LTO application electronically. The system guides you through the application process and allows you to upload supporting documents.
How to apply via FDA eServices:
- Go to the FDA eServices portal at eservices.fda.gov.ph
- Register for a new account if you don't have one (provide company details, authorized representative information, and valid email address)
- Log in to your account and navigate to the "License to Operate" section
- Select "New Application" and choose your establishment type and product category
- Fill out the application form with complete and accurate information about your establishment
- Upload all required supporting documents in the specified file formats (PDF, JPEG)
- Review all information carefully before submitting the application
- Submit the application and note the reference number for tracking
Tip: Ensure all uploaded documents are clear, legible, and complete. Blurred or incomplete documents will result in a "Return to Applicant" (RTA) status, which means you will need to re-upload the documents and wait for re-evaluation, adding weeks to your processing time.
Pay Processing Fees
After submitting your application and upon initial review by the FDA, you will receive an Order of Payment (OP) indicating the fees to be paid. Processing fees vary depending on the establishment type, product category, and number of product lines. Payment can be made through authorized payment channels.
Fee guidelines and payment channels:
- LTO application fees typically range from ₱1,000 to ₱15,000 depending on the establishment type and product category
- Additional fees may apply for inspection, certification, and other ancillary services
- Payments can be made through the FDA Cashier, Land Bank of the Philippines, or other authorized government payment channels
- Online payment options may be available through the FDA eServices portal via authorized payment gateways
- Keep the official receipt as proof of payment — you will need to upload it to the eServices portal
Sample fee schedule (for reference only — verify with FDA for current rates):
- Food Manufacturer: ₱3,000 to ₱10,000 (depending on production capacity)
- Drug Manufacturer: ₱5,000 to ₱15,000 (depending on dosage forms)
- Cosmetic Manufacturer: ₱3,000 to ₱8,000
- Importer/Exporter: ₱3,000 to ₱10,000
- Distributor/Wholesaler: ₱2,000 to ₱5,000
- Retailer (Pharmacy/Drugstore): ₱1,000 to ₱3,000
FDA Facility Inspection
After payment verification, the FDA will schedule a facility inspection to verify your establishment's compliance with the applicable GMP/GDP standards. The inspection is a critical step — your LTO will not be issued until the FDA inspectors confirm that your facility meets all requirements. The inspection may be conducted by FDA central office inspectors or FDA regional field office inspectors, depending on your location and establishment type.
What to expect during the FDA inspection:
- Opening conference: FDA inspectors will introduce themselves, explain the scope of the inspection, and request relevant documents
- Facility walkthrough: Inspectors will tour your entire facility including production areas, storage rooms, quality control laboratory, personnel areas, and waste disposal areas
- Document review: Inspectors will examine your SOPs, batch records, quality manual, training records, calibration records, pest control logs, and sanitation records
- Personnel interviews: Inspectors may interview key personnel including the quality assurance head, production supervisor, and technical staff to assess their knowledge and competence
- Closing conference: Inspectors will discuss their findings, identify any observations or non-conformities, and provide guidance on corrective actions needed
Warning: If major non-conformities are found during the inspection, the FDA may issue a "Not Satisfactory" rating. In this case, you must address all findings and submit a Corrective Action Preventive Action (CAPA) report before a re-inspection can be scheduled. This can significantly delay the issuance of your LTO by several weeks or months.
Issuance of LTO/Establishment Registration
Upon satisfactory completion of the facility inspection and final evaluation of all submitted documents, the FDA will issue your License to Operate (LTO). The LTO contains your establishment's registered name, address, licensed activities, product categories, and validity period. The LTO is typically valid for up to 5 years, depending on the product category and establishment type. You can download and print your LTO from the FDA eServices portal.
After receiving your LTO:
- Display your LTO prominently in your establishment premises as required by FDA regulations
- Proceed with product registration (CPR) or product notification for each product you intend to manufacture, import, or distribute
- Maintain continuous compliance with GMP/GDP standards throughout the validity of your LTO
- Keep all records updated and available for FDA surveillance inspections at any time
- Notify the FDA of any significant changes to your establishment (change of address, change of activities, change of key personnel)
- Apply for LTO renewal at least 60 days before the expiry date to ensure uninterrupted operations
Complete Documentary Requirements
Below is a comprehensive table of all documentary requirements for FDA establishment registration. Requirements are categorized as "Required for All" or specific to certain establishment types. Ensure you prepare all applicable documents before submitting your application.
| Document | Description | Applicable To |
|---|---|---|
| Floor Plan | Detailed layout of the establishment showing all areas including production, storage, quality control, personnel, and waste management areas with measurements | All establishment types |
| Equipment List | Complete list of all equipment used in operations including brand, model, capacity, and calibration status | Manufacturers, Repackers |
| Personnel Qualifications | Organizational chart with resumes and licenses of key technical personnel (pharmacist, food technologist, chemist, quality assurance head) | All establishment types |
| SOP Manual | Standard Operating Procedures covering all critical operations including receiving, production, quality control, storage, distribution, recall, and complaint handling | All establishment types |
| Business Registration | SEC Registration (for corporations/partnerships), DTI Registration (for sole proprietorship), or CDA Registration (for cooperatives) | All establishment types |
| Mayor's Permit / Business Permit | Valid business permit issued by the local government unit where the establishment is located | All establishment types |
| Quality Manual | Document describing the quality management system, quality policy, quality objectives, and quality organizational structure | Manufacturers, Importers |
| Product List | Complete list of all products to be manufactured, imported, or distributed with product names, dosage forms, and packaging sizes | All establishment types |
| Sanitation & Pest Control Program | Documented sanitation schedule, cleaning procedures, and pest control program with contract or in-house pest control records | Manufacturers, Repackers, Distributors with storage |
| Water Analysis Report | Laboratory analysis of water supply confirming potability and compliance with Philippine National Standards for Drinking Water (PNSDW) | Food and Drug Manufacturers |
| GMP/GDP Certificate (Foreign) | GMP certificate issued by the regulatory authority of the country of origin for imported products | Importers |
| Waste Management Plan | Documented procedures for proper handling, storage, and disposal of wastes generated by the establishment, including hazardous waste permits if applicable | Manufacturers, Repackers |
Complete Example
Juan Registers His Food Manufacturing Facility
Background: Juan dela Cruz is a food entrepreneur who wants to establish a canned goods manufacturing facility in Cavite. His company, "Juan's Best Foods, Inc.," plans to produce canned sardines, canned corned beef, and canned fruit cocktail for distribution in Metro Manila and neighboring provinces. Juan's facility is a 500-square-meter building with dedicated production, packaging, storage, and quality control areas. He has already registered his corporation with the SEC and obtained his Mayor's Permit from the Cavite LGU.
Step 1: Juan Determines His Establishment Type
Juan identifies his establishment as a "Food Manufacturer" since he will be processing raw materials (fresh fish, meat, and fruits) into finished canned goods. He also plans to distribute his products directly to retail stores, so he will also register as a "Distributor." He confirms that his product category is "Processed Food" and that he needs a licensed food technologist as his technical personnel. He verifies with the Cavite LGU that his factory location is zoned for industrial/manufacturing use.
Step 2: Juan Prepares His Facility for GMP Compliance
Juan hires a food technology consultant to help design his facility layout in compliance with Food GMP and HACCP standards. The consultant advises on proper workflow from raw material receiving to finished goods storage, ensuring no cross-contamination points. Juan invests in stainless steel equipment, installs proper ventilation and temperature control systems, builds separate changing rooms for production staff, and contracts a licensed pest control service provider. He also installs a water treatment system and has his water supply tested by an FDA-accredited laboratory. Total facility preparation cost: approximately ₱2.5 million.
Step 3: Juan Gathers His Documents
Juan prepares all required documents: his SEC Certificate of Registration, Mayor's Permit, detailed floor plan prepared by a licensed architect, complete equipment list with calibration certificates, HACCP plan for each product line, SOP manual covering 35 standard operating procedures, Quality Manual, organizational chart showing his food technologist, production supervisor, quality control staff, and maintenance team, along with their respective qualifications and training records. He also prepares the water analysis report, sanitation program, pest control contract, and waste management plan.
Step 4: Juan Submits His Application Online
Juan creates an account on the FDA eServices portal at eservices.fda.gov.ph, registers his company "Juan's Best Foods, Inc." and designates himself as the authorized representative. He selects "New LTO Application" for a "Food Manufacturer" establishment and fills out all the required fields including establishment name, address, product categories, and activities. He carefully uploads all documents in PDF format, ensuring each file is clear and legible. After reviewing everything, he submits the application and receives reference number FDA-LTO-2025-00XXXX.
Step 5: Juan Pays the Processing Fees
After 5 business days, Juan receives an Order of Payment through the eServices portal. The total fee for his food manufacturing LTO application is ₱7,500 (application fee of ₱5,000 plus inspection fee of ₱2,500). Juan pays through Land Bank of the Philippines using the reference number from his Order of Payment. He uploads the scanned official receipt to the FDA eServices portal to confirm payment.
Step 6: FDA Conducts the Facility Inspection
Two weeks after payment verification, the FDA Regional Field Office in CALABARZON schedules Juan's facility inspection. Two FDA inspectors arrive at the facility and conduct a thorough inspection over two days. During the opening conference, the inspectors request Juan's SOPs, HACCP plans, training records, and equipment calibration certificates. They conduct a walkthrough of the entire facility, checking the flow of materials, sanitation conditions, equipment qualification, and storage areas. They interview Juan's food technologist and production supervisor to assess their knowledge of GMP procedures. During the closing conference, the inspectors note two minor observations: (1) one temperature logger in the cold storage needs recalibration, and (2) a handwashing station needs a hands-free faucet upgrade. Overall rating: "Satisfactory with minor observations."
Step 7: Juan Receives His LTO
Juan promptly addresses the two minor observations — he recalibrates the temperature logger and installs a hands-free faucet. He submits photos and documentation of the corrective actions to the FDA through the eServices portal. After the FDA verifies the corrective actions, Juan's LTO is approved and released. He downloads and prints his LTO from the portal, which is valid for 5 years. The LTO shows his establishment name, address, LTO number (FDA-LTO-XXXX-XXXX), licensed activities (Food Manufacturer, Distributor), and product categories (Canned Fish, Canned Meat, Canned Fruits). Juan proudly displays the LTO in his factory's reception area and proceeds to register his individual products with the FDA.
| Detail | Juan's Case |
|---|---|
| Establishment Name | Juan's Best Foods, Inc. |
| Establishment Type | Food Manufacturer & Distributor |
| Product Category | Processed Food (Canned Goods) |
| GMP Standard Applied | Food GMP / HACCP |
| Technical Personnel | Licensed Food Technologist |
| Facility Size | 500 square meters (Cavite) |
| Total Fees Paid | ₱7,500 (application + inspection) |
| Inspection Result | Satisfactory with minor observations |
| LTO Validity | 5 years |
| Total Processing Time | Approximately 6-8 weeks from application to LTO issuance |
Frequently Asked Questions (FAQ)
Q: Can home-based establishments register with the FDA?
A: Yes, the FDA allows home-based food processing establishments to register and obtain an LTO, subject to certain conditions. Home-based food processors must still comply with Food GMP requirements appropriate for their scale of operation. The FDA has issued Administrative Order No. 2014-0029 which provides guidelines for the licensing of micro and small food processing establishments, including home-based operations. However, the production area must be physically separated from the living quarters, and the facility must meet basic sanitation, hygiene, and food safety requirements. Home-based cosmetic manufacturing may also be allowed under certain conditions. Drug manufacturing, however, is generally not permitted in home-based settings due to the stricter PIC/S GMP requirements.
Q: Can I manufacture multiple types of products in one facility?
A: Yes, you can manufacture multiple product types in a single facility, provided that the facility meets the GMP requirements for each product category and that adequate measures are in place to prevent cross-contamination between different product lines. For example, a facility manufacturing both food products and cosmetics must have separate and dedicated production areas, equipment, and storage spaces for each product category. The FDA will evaluate the adequacy of your cross-contamination prevention measures during the facility inspection. Your LTO application should list all product categories and activities to be conducted in the facility.
Q: What is contract manufacturing, and does the contract manufacturer need a separate LTO?
A: Contract manufacturing (also known as toll manufacturing) is an arrangement where a company (the principal or brand owner) engages another company (the contract manufacturer) to produce health products on its behalf. Both the principal and the contract manufacturer must have their own separate LTOs from the FDA. The contract manufacturer's LTO must cover the specific product categories and manufacturing activities being contracted. A written contract manufacturing agreement must be in place, and both parties must submit copies to the FDA. The contract manufacturer's facility must be GMP-compliant and will be subject to FDA inspection. The principal remains responsible for the quality and safety of the finished products.
Q: Do I need a separate GMP certification before applying for an LTO?
A: For domestic establishments, a separate GMP certification is not required before applying for an LTO. The FDA evaluates GMP compliance as part of the LTO application process through the facility inspection. If your facility passes the inspection, your LTO issuance effectively confirms your GMP compliance. However, for imported products, the FDA requires a GMP certificate issued by the regulatory authority of the country of origin. If you plan to export your products to other countries, you may need to apply for a separate Certificate of GMP Compliance from the FDA, which other countries may require as part of their import requirements.
Q: How should I prepare for the FDA facility inspection?
A: Preparing for the FDA inspection requires thorough attention to both your facility and documentation. Ensure your facility is clean, organized, and operating according to your SOPs. All equipment should be calibrated and in good working condition. Have all documents readily accessible including your SOPs, quality manual, training records, batch records, calibration certificates, sanitation logs, pest control records, and water analysis reports. Brief your key personnel (quality assurance head, production supervisor, food technologist/pharmacist) on GMP principles and your company's quality procedures, as they may be interviewed by the inspectors. Conduct an internal self-audit using the FDA inspection checklist before the scheduled inspection to identify and address any gaps.
Q: What happens if my LTO application is denied or if I fail the inspection?
A: If your LTO application is denied due to incomplete documents, you will receive a "Return to Applicant" (RTA) notice specifying the deficiencies. You must address all deficiencies and re-submit within the prescribed timeframe. If your facility fails the inspection (receives a "Not Satisfactory" rating), the FDA will issue an inspection report detailing the non-conformities. You must prepare and submit a Corrective Action Preventive Action (CAPA) report addressing all findings. After implementing the corrective actions, you can request a re-inspection. The re-inspection fee will apply. If the re-inspection is satisfactory, the LTO processing will continue. In cases of serious or repeated non-compliance, the FDA may deny the application entirely, and you would need to file a new application after fully addressing all issues.
Important Reminders
- Register before operating: Operating an establishment that handles FDA-regulated health products without a valid LTO is a violation of RA 9711 (FDA Act of 2009) and may result in fines of up to ₱5 million, imprisonment, or both
- Invest in GMP compliance early: Proper facility design and GMP compliance from the start will save you from costly renovations, inspection failures, and application delays later on
- Engage qualified technical personnel: Food establishments require a licensed food technologist, drug establishments require a licensed pharmacist, and cosmetic establishments require a licensed chemist. These professionals must be employed or engaged before applying for the LTO
- Keep all documents updated and organized: The FDA may conduct unannounced surveillance inspections at any time. All GMP records, batch records, training records, and quality documents must be current and readily accessible
- Notify FDA of any changes: If you change your establishment address, add new product categories, modify your facility layout, or change key personnel (quality assurance head, technical personnel), you must notify the FDA and, in some cases, apply for an amended LTO
- Renew your LTO before expiry: File your LTO renewal application at least 60 days before the expiration date. Operating with an expired LTO is treated the same as operating without an LTO and carries the same penalties
- Use the official FDA eServices portal: All LTO applications, renewals, and amendments must be filed through the FDA eServices portal at eservices.fda.gov.ph. Do not transact with fixers or unauthorized intermediaries who claim they can expedite FDA processing
- Product registration follows LTO issuance: You must first obtain your LTO before you can apply for product registration (CPR) or product notification. The LTO is a prerequisite for all product registration applications
- Maintain a recall and complaint system: Your establishment must have documented procedures for handling product complaints, adverse event reports, and product recalls. The FDA requires establishments to be able to trace and recall products from the market within 24-48 hours if needed
- Stay updated with FDA advisories: The FDA regularly issues administrative orders, circulars, and advisories that may affect your establishment's compliance requirements. Subscribe to FDA announcements and regularly check the FDA website for updates
Need Help?
If you have questions about FDA establishment registration or need assistance with your LTO application, you can contact the FDA through the following channels:
FDA Hotline
Phone: (02) 8857-1900
Available Monday to Friday, 8:00 AM to 5:00 PM
FDA Regional Field Offices: For establishments outside Metro Manila, you may also contact the FDA Regional Field Office in your area. Regional offices handle facility inspections and can provide guidance on local compliance requirements. Visit the FDA website for the complete directory of regional field offices and their contact information.
Disclaimer
This guide is provided for general informational purposes only. The requirements, steps, fees, and procedures mentioned here may vary depending on the FDA you visit. We recommend visiting your nearest FDA first to confirm the specific requirements and process before preparing your documents.