Philippines Updates Requirements for License to Operate (LTO) Application

On November 27, 2024, the Philippines FDA unveiled Administrative Order No. 2024-0015 Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments, which will come into force 15 days after the publication date and will repeal Administrative Order No. 2020-0017 Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration.

1. Background

The Philippines requires all companies that manufacture, import, distribute, or sell food products to obtain a License to Operate (LTO) from the FDA. In 2020, AO No. 2020-0017 was issued, outlining the necessary documents and procedures for LTO applications. To further streamline the processes for initial, renewal, and variation applications for LTO, the FDA introduced amendments to AO No. 2020-0017 in 2022 and 2023, respectively. With the release of AO No. 2024-0015, updated guidelines on LTO application are finally established.

2. Objectives

The new order was promulgated under three core objectives:

1) To prescribe the updated rules, requirements and procedures for LTO application.

2) To keep in line with internationally acceptable standards and new local legislations.

3) To institutionalize a longer validity period of LTO, and the administrative reconsideration mechanism in the regulatory licensing processes.

3. Key updates

1) Specific guidelines for FBO

The new order emphasizes the following specific guidelines for food business operators (FBOs):

All FBOs must adhere to current guidelines on good manufacturing and hygienic practices, mandatory standards, and national food regulations.
Where applicable, FBOs must also comply with standards for Hazard Analysis and Critical Control Point (HACCP), Sanitary Standard Operating Procedures (SSOP), and other relevant regulations and guidelines.
A LTO is required for FBOs to participate in food trade and exhibitions, conduct market research, or perform laboratory testing/analysis of processed food products.

2) Requirements for initial, renewal and variation application

The new order updates the requirements for initial, renewal and variation applications respectively. Moreover, for renewal requirements, in addition to regular renewal, the requirements for automatic renewal are also added.

Application types	Requirements
Initial	1. Accomplished e-Application form with Declaration of Undertaking; 2. Proof of business name registration and FDA-regulated activity; 3. For micro small medium enterprises (MSMEs), latest audited Financial Statement with Balance Sheet; 4. Risk Management Plan (RMP); 5. Site Master File (SMF); 6. List of sources and authorized supplier/clients for manufacturers including packers/repackers, traders, and distributors (importers, exporters, wholesalers); 7. Payment of fees
Renewal	1. Accomplished e-Application form with Declaration of Undertaking; 2. For micro small medium enterprises (MSMEs), latest audited Financial Statement with Balance Sheet; 3. Payment of fees Automatic Renewal: 1. Accomplished e-Application form with Declaration of Undertaking; 2. The application is filed; 3. The prescribed renewal fee is paid; 4. A sworn statement (Declaration and Undertaking) indicating no change or variation whatsoever in the establishment is attached
Variation	1. Accomplished e-Application form with Declaration of Undertaking; 2. Documentary requirements depending on the variation; 3. Payment of fees; 4. Major variation: RMP, SMF

3) The validity of LTO

The validity period of the issued LTO is extended as follows:

Old validity

New validity

Initial

2 years

3 years (micro and small enterprises);

6 years (medium and large enterprises)

Renewal

5 years

6 years (micro and small enterprises);

12 years (medium and large enterprises)

4) Decision of the application

This order clarifies the grounds for approval and disapproval of LTO application, and the reconsideration on the disapproved application.

Decision of the application	Grounds for FDA's Decision
Approval	1. Upon evaluation, the submitted application is deemed compliant; 2. During inspection, the company demonstrates full adherence to technical standards.
Disapproval	1. The application requirements submitted, and/or the inspection show that the establishment does not meet the requirements or appropriate standards; 2. The applicant made misrepresentations, false entries, or withheld any relevant data contrary to the provisions of FDA-implemented regulations; 3. The owner has violated any of the terms and conditions of its license in case of renewal applications; 4. Other analogous grounds or causes.
Suspension, or Cancellation/Revocation	1. The applicant has willfully violated FDA-implemented regulations, or failed to file a renewal application 120 days after the previously issued LTO expired; 2. The application requirements submitted show that the establishment does not meet the required technical requirements or appropriate standards; 3. The applicant made misrepresentations, false entries, or withheld any relevant data contrary to the provisions of FDA-implemented regulations; 4. The owner has violated any of the terms and conditions of its license; 5. Other analogous grounds or causes.

For disapproved applications, applicants may request for reconsideration within 15 days of the disapproval notification, with payment of the reconsideration fee. The request must address specific unsupported findings in the disapproval, and FDA shall resolve the request within 20 working days.