Chapter 1 PFDA Regulatory Information in the Philippines

1. Eaa and Introduction

Philippine Food and Drug Administration (PFDA) Responsible for approving and supervising the market access, sales and subsequent compliance supervision of cosmetics.

2. Supervision and regulation

 ASEAN Cosmetic Directive (ACD)

3. Philippine Definition of Cosmetics

Cosmetics are substances and products that come into contact with various external organs of the human body, such as the skin, hair system, fingernails (toes), lips and external genitals, or teeth and mucous membranes in the mouth, for the main purpose of cleaning, aromatherapy, improving appearance or improving body odor, protecting or maintaining good condition.

4. Entry requirement

• ISO  22716 Certificate

• LAR

• Registration related documents (if applicable) : manufacturer information, product information, intended use, PIF documents, etc

• Full ingredient list and label

5. Registration language 

English

6. Philippine LTO

The LTO, or Operating License, is a required qualification for importers, distributors, traders and manufacturers of medical devices in the Philippines. It is used to ensure that enterprises legally operate cosmetic products, 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

The application will be processed within 14 natural days after submission.

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 cosmetic products.

Q：How long is a Notification valid?

A：Three years.