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Liz Servañez
Liz Servañez serves as Branch Manager in the Philippines.
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Christine Aguilar
Christine Aguilar serves as Head of Operations in the Philippines.
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Ross Vincent Gonzales
Ross Vincent Gonzales is a Senior Account Executive in the Philippines.
Are you planning to import, manufacture, or distribute products in the Philippines? Then you must ensure that your operations are properly registered with the FDA and secure a License to Operate to avoid the risk of business closure.
This guide will walk you through the essentials of License to Operate, including key requirements and process of securing an FDA LTO.
Overview of the FDA License to Operate in the Philippines
An FDA License to Operate (LTO) is an official authorization issued by the Philippine Food and Drug Administration that allows businesses to legally manufacture, import, export, or distribute FDA-regulated products such as food, drugs, cosmetics, and medical devices.
The FDA-regulated industries in the Philippines include:
- Food and beverages
- Cosmetics
- Drugs and pharmaceuticals
- Medical devices
- Vaccines
- In Vitro Diagnostic Devices and Reagents
- Household hazardous products
- Pesticides
- Toys and childcare articles
According to Administrative Order No. 2016-003, companies that operate within one of the regulated industries in the Philippines must secure a License to Operate from the FDA before undertaking any of the main business activities.
Who Needs to Obtain the FDA LTO?
Businesses that require an FDA LTO in the Philippines include:
- Manufacturers, repackers, and refurbishers
- Importers, exporters, wholesalers
- Traders
- Retailers of medical/health-related products
- Pharmacies, drugstores, and retail outlets for non-prescription drugs (RONPDs)
- Veterinary pharmaceutical retailers
- Contract Research Organizations (CROs) and sponsors
Keep in mind that the License to Operate is required before starting any of these activities, and that failure to secure one can result in penalties, fines, and company closure.
Depending on your industry and the type of products you work with, you will likely need to acquire additional certificates such as Certificate of Product Registration. To learn more, read our article on FDA registration in the Philippines.
FDA License to Operate Requirements in the Philippines
1. Business Registration
The first requirement for expanding your business into an FDA-regulated industry in the Philippines is that you have a business that is properly registered in the country with a physical location.
This can be provided via any of the following depending on your type of business entity:
- Corporations: Certificate of Registration with SEC and Articles of Incorporation/Partnership
- Single Proprietorship: Certificate of Business Name Registration with DTI
- Cooperatives: Certificate of Registration issued by the Cooperative Authority and Articles of Incorporation
If you have not yet set up a company, Emerhub’s business advisors can help you with the process through our company registration service.
2. Declaration and Oath of Undertaking along with Application Form
The official application form is accompanied by a declaration and an oath of undertaking. This is a formal declaration where the applicant commits to complying with all FDA regulations and standards. The details of the document depend on your product categories and business types.
3. Proof of Income
For proof of income, you need to submit the last audited financial statement with a balance sheet or duly notarized statement. If the business is new, FDA allows business owners to submit a notarized sworn statement of initial capital for validation.
4. Registered Business Address
Provide documentation proving your business location. This typically includes a registered business address or proof of occupancy, along with a floor plan, GPS coordinates, and a vicinity map of your premises. This is required for all your physical facilities.
5. Having a Certified Professional
The next prerequisite for FDA LTO is that your company employs or partners with a licensed or board-certified health science professional or a pharmacist. The specific credentials of the certified professional can vary depending on your industry of operation:
| Industry | Profession | Credentials |
| Drug | Pharmacist | Professional Regulation Commission (PRC) ID Certificate of Attendance in a related FDA licensing seminar |
| Pharmacy Assistant (Drugstore / RONPD) | Certificate of Training | |
| Food | Food Safety Compliance or Regulatory officer | Certificate of attendance in a related FDA licensing seminar Certificate of Attendance in Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Point (HACCP), or Food Safety Seminar |
| Medical Device | Pharmacist or any other qualified professional | PRC ID or proof of qualification Certificate of Attendance in Medical Device Qualified Person in Industry Regulatory Affairs (QPIRA) training |
| Cosmetics | Pharmacist or any other qualified professional | PRC ID Certificate of Attendance in QPIRA training |
6. Additional Industry-Specific Requirements
Depending on your specific industry and type of operation, you may need to submit additional documents. For example, importers may need to provide a Foreign Agency Agreement, while manufacturers will need to submit a Site Master File and Risk Management Plan.
Specific technical documents will be requested depending on the nature of your business, and relevant contracts, like agreements for outsourced manufacturing, must be presented when requested by the FDA.
How to Apply for An LTO in the Philippines
To secure the FDA License to Operate in the Philippines you need to show that your company meets the pre-requisites for operating in a regulated industry.
Here’s the step-by-step process to obtain the FDA LTO:
Step 1: LTO Application Filing
To apply for the License to Operate, the first step is to gather all required documents based on your operations and submit your application using the FDA’s online portal.
Once the application is submitted, it will go through a pre-assessment phase to see whether it meets all the requirements. If approved, the applicant will need to make the necessary payment before moving on to the detailed evaluation phase.
Emerhub’s local experts will handle all submissions on your behalf, ensuring a smooth process and addressing any objections that may arise.
Step 2: Technical Evaluation of the Application by FDA
During this phase, the FDA will conduct a technical evaluation of your product to ensure it meets all regulatory requirements. This involves an in-depth review of operational processes, risk management strategies, and compliance with FDA standards based on product category.
Step 3: Inspection
After passing the evaluation phase, the next step is to arrange for an FDA inspection of your facilities. FDA representatives will assess your premises to ensure adherence to Good Manufacturing Practices (GMP) and other relevant standards.
Once your facility passes inspection and your application is approved, the FDA will issue your LTO through the ePortal. With this, you can proceed with further product registration applications such as CPR, CPN, or CMDR.
Validity and Timeline for FDA LTO
The FDA issues the LTO for an initial validity period of three years for small enterprises and up to 6 years for medium to large enterprises. After reaching the term of the initial license, it is possible to renew the LTO for an additional 6 years for small enterprises and 12 years for medium to large enterprises.
The timeline for securing the LTO is 6-8 Weeks, depending on your business activities. Therefore, it is advisable to apply for renewal at least three months before the current LTO expires to avoid any operational disruptions.
To keep track of all license renewals and other important compliance deadlines, you can create an account on the Emerhub App. Our platform helps you manage your regulatory obligations efficiently, ensuring you never miss a critical deadline.
Secure Your FDA License to Operate with Emerhub
Looking to apply for FDA License to Operate in the Philippines? Emerhub’s local experts can help.
Our advisors will manage the LTO application process in your stead, and we can put in place all the necessary submissions for renewing your LTO.
Fill out the form below and we will put you in touch with one of our experts.
FAQ on FDA License to Operate in the Philippines
Yes, an LTO authorizes your business to operate in the Philippines, but product registration authorizes the sale of specific products. You must secure an LTO before applying for product registration.
Site inspections are usually not required for initial LTO applications, especially for lower-risk activities, but may be necessary for certain product categories or at the FDA’s discretion. Site inspections are more likely for manufacturing facilities and high-risk operations.
Yes, if your business is engaged in multiple regulated activities, then you may need to apply for separate or appropriately classified LTOs. Different regulated activities have different requirements and compliance obligations.
A Site Master File (SMF) is a detailed document describing your facility’s operations, layout, equipment, sanitation procedures, and quality control systems. It’s required for manufacturers and certain distributors.
An RMP outlines how you identify, monitor, manage, and mitigate risks related to product safety and quality. It is required for specific high-risk product categories.
