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The License to Operate (LTO) is a permit granted by the Philippines Food and Drug Administration (FDA) that authorizes the holder to conduct business activities in the Philippines. It is also a prerequisite for notifying cosmetic products with the FDA. In order to streamline LTO application requirements and procedures, as well as the FDA's review workflows, the Philippines FDA published the Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003 in 2020, otherwise known as Administrative Order (AO) No. 2020-0017.
Within this article, ChemLinked explores the fundamental requirements for and steps of LTO application, along with an introduction of the most recent updates.
Application Procedures
As per FDA Circular No. 2016-004, titled Procedure on the Use of the New Application from for License to Operate (LTO) Through the FDA Electronic Portal (e-Portal), LTO applications should be filed through the FDA's e-Portal system. To gain access, applicants shall first obtain a user account by sending a request to [email protected] with an attached Authorization Letter, in the format specified below:
Subject: Request for eLTO User Account
Body:
E-mail address (preferably company e-mail address)
Name of the authorized company representative (preferably permanently employed and not merely a consultant)
Position in the company
Contact number
Company name
Attachment: Authorization letter
The user account is company-specific, and valid for one year. After obtaining this account, applicants can log into the e-Portal, and initiate their LTO applications following a four-step procedure. Depending on whether the applicant is a cosmetic manufacturer or a cosmetic trader, the entire initial application process takes 14-20 working days.
Dossier Requirements
AO No. 2020-0017 lays out necessary documents for LTO applications. The required dossiers vary based on the application type, as shown in the provided table. Apart from the listed documents, additional papers may be needed by the FDA during inspections. For instance, for cosmetic manufacturers applying for their initial LTO, this includes the Site Master File and Risk Management Plan.
| Application Type | Basic Requirements |
| Initial | - Accomplished e-application form with declaration of undertaking - Proof of business name registration - Business permit (if applicable) - Proof of income (latest audited financial statement with balance sheet) - Payment of fees |
| Renewal | - Accomplished e-application form with declaration of undertaking |
| Variation | - Accomplished e-application form with declaration of undertaking - Documentary requirements depending on the variation - Payment of fees |
When completing the e-application form, applicants are required to input company specifics, contact information, office and warehouse addresses, details of the Qualified Person (QP), etc. The QP refers to an organic or full-time employee of the establishment who possesses technical competence related to the establishment's activities and health products by virtue of his profession, training and/or experience. According to AO No. 2020-0017, the QP designated by cosmetics establishments shall meet the specified qualifications:
| Establishment Type | Qualified Person | Qualifications/Requirements |
Manufacturers, traders, and distributors (wholesalers, importers, and exporters) of cosmetics establishments | - Registered professional or graduates in the field of allied health profession; - For manufacturers only: registered chemist, chemical engineer, and pharmacist | - Professional Regulation Commission identification card for professions with board/licensure exam, or diploma for professions without board/licensure exam; |
Latest Updates
To further optimize LTO applications, the FDA has proposed a series of amendments to AO No. 2020-0017 between 2022 and 2024.1-3 Through these amendments, the FDA plans to update the requirements for, FDA's decision grounds for, and validities of LTO applications, strengthen the requirements for the QP, and establish a more comprehensive inspection plan.
During the transition to digital licensing and registration, the FDA has developed several systems over the years. To eliminate the inefficiencies and redundancies associated with multiple platforms, the FDA aims to unify its regulatory services under the FDA eServices Portal System. On November 30, 2023, the FDA initiated a public consultation on the draft of Guidelines on the Filing and Submission of Applications for the Licensing of Cosmetic Establishments through the Food and Drug Administration (FDA) eServices Portal System, which provides procedural guidance for all types of LTO applications for cosmetic establishments using the new system.4
These proposed amendments are still under review. ChemLinked will keep track of the developments, and provide timely updates once the amendments are finalized and implemented.
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