FDA License to Operate (LTO)

An FDA License to Operate (LTO) is a requirement for businesses operating in the Philippines that import, export, distribute, sell, or manufacture food, cosmetics, drugs, health products, and medical devices. It is a legal license issued by the Food and Drug Authority (FDA) in the Philippines. Obtaining an LTO is a prerequisite for securing a Certificate of Product Registration (CPR) for your product from the FDA.

According to Administrative Order No. 2016-003, the following types of businesses are required to secure an LTO:

1. Manufacturers, traders, and distributors (importers, exporters, and wholesalers) of processed foods, drugs (including vaccines, biologics, veterinary drugs, and products), cosmetics, medical devices, in-vitro diagnostic devices and reagents, household/urban pesticides, toys, and child care articles.
2. Drugstores/pharmacies/boticas and retail outlets for non-prescription drugs (RONPD).

The following establishments are not covered by Order 2016-003 and are not required to secure an LTO to operate:

1. Operators and applicators of household or urban pesticides.
2. Importers/distributors of collector’s items.
3. Organizers of national and international trade fairs and exhibits.
4. Retail outlets of food, cosmetics, medical devices, in-vitro diagnostic devices and reagents, household/urban hazardous substances, toys, and child care articles.
5. Organizations or individuals engaged in donations, medical missions, and other humanitarian activities.

• Certificate of Registration with the Securities and Exchange Commission (SEC) and Articles of Incorporation/Partnership. For single proprietorships:
• Certificate of Business Name Registration with the Department of Trade and Industry (DTI). For cooperatives:
• Certificate of Registration issued by the Cooperative Authority and Articles of Cooperation.
• Proof of income (Last Audited Financial Statement with Balance Sheet) or duly notarized Statement/Certificate of Initial Capitalization.
• Location plan and Global Positioning System (GPS).
• Name of the Qualified Person depending on the type of health product establishment; Professional Regulation Commission (PRC) ID.

1. Visit the FDA portal at http://www.fda.gov.ph – or Contact Us for assistance.
2. Navigate to the “New Case” section in the upper left-hand corner and select “License to Operate v2.0” under Electronic Licensing.
3. Go to the General Information tab and choose your Product Type, Primary Activity, and Type of Application from the drop-down menu.
4. Provide all necessary business information under the Establishment Information section.
5. Fill in the required details for the Authorized Officer and Applicant.
6. Upload all required documents in PDF format.
7. Check the Order of Payment section for the total amount to be paid.
8. Complete the application by making the payment.
9. For manufacturers, the establishment must undergo a pre-inspection before the initial LTO is issued.
10. After the physical inspection by the FDA office, wait for the approval of your application from the LTO Director.
11. Wait for the release of your documents.

Failure to comply with the FDA licensing requirements may result in penalties, including but not limited to fines, suspension, revocation of the LTO, and legal actions. It is important for businesses to adhere to the regulations and maintain compliance to avoid these penalties and ensure the lawful operation of their establishments.

For a quicker and more convenient process of obtaining your business operating license, it is advisable to seek assistance from professionals.

Triple i Consulting Inc. has a decade-long experience in navigating the Philippine government system, handling government paperwork, and acquiring business certificates and FDA LTOs. They specialize in various areas such as accounting, business registration, business incorporation, FDA licensing, and FDA product registration. As the pioneering ISO 9001:2008 company in the Philippines providing business registration services, Triple i Consulting is well-equipped to cater to its client’s needs.

To schedule an initial consultation with one of our FDA compliance experts, please feel free to reach out to us through the following contact options:

• Fill out the form below
• Contact Us here
• Call us at +63 (02) 8540-9623
• Email us at info@tripleiconsulting.com.