How to Get an FDA LTO (License to Operate)

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What is an FDA License to Operate (LTO), and why does your business need it?

A license to operate (LTO) is a license your business needs to enable your company to import, export, distribute, sell and manufacture food, cosmetics, drugs, health products, and medical devices in the Philippines legally. 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.

Establishments that fail to apply for renewal after one hundred and twenty (120) days from the expiration will inevitably be canceled by the Food and Drug Authority (FDA). Your business will also be removed from the FDA’s list of licensed establishments.

What businesses are required to secure an LTO?

As per Administrative Order No. 2016-003, or the Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration, these are the types of businesses that are required to secure an LTO:

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

Which businesses are exempted from securing an LTO?

The following is a list of establishments that are not covered by Order 2016-003 and are not required to secure LTO to operate their businesses:

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

• For corporations: Certificate of Registration with SEC and Articles of Incorporation/Partnership
• For single proprietorships, Certificate of Business Name Registration with DTI
• For cooperatives, the 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; PRC ID

• Visit the FDA portal at http://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.
• Fill out all the fields regarding your business under the Establishment Information.
• Similarly, fill out the information needed under the “Details of the Authorized Officer” and “Details of the Applicant”. Upload all documents required in PDF format.
• Check the total amount to be paid in the Order of Payment section.
• Complete application through payment.
• For manufacturers, the establishment shall undergo pre-inspection prior to the issuance of initial LTO.
• After the office’s physical inspection, wait for your application’s approval from the LTO Director.
• Wait for the release of your documents.

Can I get help securing an LTO for my business in the Philippines?

To ensure a speedier and more convenient way of securing the license to operate for your business, seek help from professionals.

Triple i Consulting Inc’s knowledge and skills in the Philippine government system, processing government documents, and securing business certificates and FDA LTOs date back to 10 years. Specializing in accounting, business registration, business incorporation, FDA licensing, and FDA product registration, to name a few , Triple i Consulting is the first ISO 9001:2008 company in the Philippines to offer business registration services to its clients.

Contact Us Here , fill out the form below, call us at +63 (02) 8540-9623, or email us at info@araraa.com to book an initial consultation with one of our FDA compliance experts.