Chapter 1 Philippines Regulatory Information Brief

1. Eaa and Introduction

In the Philippines, the Philippines Food and Drug Administration (PFDA), which is part of the Department of Health, oversees regulations and standards for food and food/dietary supplements, market access, and post-marketing regulation.

2. Supervision and regulation

REPUBLIC ACT NO. 9711,2009   

Derpartment circular No.2011-0101

Republic Act No.10611,2013

Republic Act No.8976,2000

Republic Act No.7394

3. Philippine classification of dietary supplements

A dietary supplement is a processed food that supplements the diet and contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs, other plant, animal, artificial or natural plant dietary substances to increase the total daily intake to meet the latest energy and nutrient intakes in the Philippines or the internationally agreed minimum daily requirements. It usually comes in the form of capsules, tablets, liquids, gels, powders, or pills and is not intended to be used as a regular food or as the sole item of a meal or diet, or as a substitute for medications and medications.

4. Entry requirement

• LTO and contact information

• Quality system certificate (GMP or ISO 22000, HACCP)

• Complete ingredient recipe, label

• Product pictures from all angles and different package sizes

• Claim supporting evidence

• trademark

• Information about manufacturers, importers, etc

• Sample, COA, stability data, safety data, etc

In addition, in accordance with the requirements of the Notification on the Source of Raw Materials, Low, Medium and High Risk Pre-Packaged Processed Foods (FDA Cirular 2016-007), manufacturers and importers are required to submit and meet the requirements for product registration certificates at the same time. The Philippines Food and Drug Administration shall be notified of the source of the raw materials used to manufacture the prepackaged processed food and the source of the prepackaged processed food.

5. Registration language 

English or Filipino

6. Philippine LTO

An LTO, or Business License, is a required qualification for local importers, distributors, traders and manufacturers of processed foods in the Philippines. It is used to ensure that enterprises legally operate processed foods, regulate market order, and ensure product quality and safety. To obtain LTO, requirements such as enterprise registration and compliance, personnel qualification training, quality management system, facilities and equipment must be met, and application preparation, submission, examination and inspection, approval and certification must be completed.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

Complete all process requirements114 natural days.

If the data is rejected and needs to be corrected, additional charges will be incurred，The review period is 57 natural days.

Chapter 3 FAQ

Q：What is an Operating License (LTO)?

A：An LTO is an authorization issued by the FDA to a business to grant a license to conduct trade or conduct commercial activities, such as the manufacture, import, export, sale, offer for sale, distribution, or transfer of processed foods.

The cost of applying for an LTO varies depending on the application, the initial application for a general food distributor (importer, exporter, wholesaler) is PHP8,080.00 (valid for 2 years), updated to PHP20,200.00 (valid for 5 years).

Q：Do I need to submit product samples?

A：Only the initial application for food supplements is required to submit a sample consistent with the electronic registration application.

Q：What information is included in shelf life research?

A：Stability data for shelf life studies should include: Conclusion parameters and method declaration Product name, batch number, production date, analysis date, physical and chemical aspects of tabular data and results as well as the names and signatures of QA analysts and QA managers. We accept the results of actual and accelerated shelf-life studies. If the shelf life study is ongoing, it contains test results for at least 6 months.

Q：What references do we use for raw material specifications for heavy metal limits?

A：If the raw material is a specific additive, you can refer to the FAO/WHO JECFA specification for heavy metal limits. You may also refer to the Codex Committee on Food Chemistry for raw material specifications for heavy metal limits.

Q：If the product label has changed, but there is already a Certificate of Product Registration (CPR), how do I apply for the revised label?

A：A modification request for CPR (Change/Add label design) needs to be submitted in the system. You will need to upload a letter of intent stating the changes made to the label and the revised label. A modification fee of 210.00 Pesos must be paid.