Philippines Amends Requirements for Application of LTO

Background

In Philippines, all cosmetic companies shall obtain a License to Operate (LTO) issued by Center for Cosmetics Regulation and Research (CCRR), which belongs to the Philippines FDA prior to engaging in in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship activities of cosmetics. The LTO is also an essential requirement to be able to notify cosmetic products with the FDA.

Philippines has released a revised draft of Guidelines on the Unified Licensing Requirements and Procedures of the FDA (hereinafter the Guidelines). Compared with the Guidelines, the significant changes in the draft are related to the amendments to the General Guidelines for LTO, and LTO Application and Renewal Process.

Unification of Application Processing

The FDA has released a circular-Procedure on the Use of the New Application Form for License To Operate (LTO) through the FDA Electronic Portal (e-portal) to specify the online application procedures for LTO. However, the Guidelines didn’t include the information in the circular because the circular is released after the Guidelines. Now the draft integrates the contents concerning the processing of online LTO application in the two regulations, details as follows:

• Online applications and processing of LTO shall be instituted by the FDA. Filing of initial and renewal of LTO shall be done online through the e-Portal of the FDA (www.fda.gov.ph).

• The status of the application may be viewed by the application online or through the doc tracking system.

• An electronic system will be established by which the applicant or authorized representative can print the LTO in the convenience of their office or home.

Addition of Requirements for Applicants

The draft newly regulates that filling-out of application forms shall be done only by duly Authorized Persons. It is the responsibility of the owner or CEO, or its equivalent, to secure the online login name and password of the online LTO application website to its authorized representative.

Redefining of Inspection Rules

The draft deletes the article related to establishment inspections in the Guidelines: the FDA will enter the establishment for (1) inspection and/or (2) verification of documents submitted to FDA in support of its application for the license, and redefines the following three new rules:

1. All establishments, except manufacturing plants or facilities, shall not require pre-licensing inspection before approval of the LTO. Inspections shall be done after licensing approval.

2. All manufacturers, manufacturing plants, and facilities applying for LTO as Manufacturer shall undergo pre-licensing inspection by the FROO, which shall be done simultaneously with the document review done by the Centers. The FROO shall forward the Certificate of Compliance (COC) to the concerned Center for issuance of the LTO.

3. The FDA shall have the authority to enter any FDA-licensed establishments during operating hours to conduct routine or spot-check inspections. It is the responsibility of the licensed establishments to recall immediately, withdraw, or remove health products from the market that is banned or declared injurious, unsafe, or dangerous by the FDA. This responsibility also applies to products or batches of products that have been found to pose an imminent danger to public health or consumer safety.

Additional Submission of a Certificate of Compliance (COC)

Compared with the Guidelines, to apply for the LTO, a Certificate of Compliance (COC) on inspections issued by the FDA is additionally required to submit.

The COC is only issued to the applicant manufacturer after complying with Good Manufacturing Practice (GMP) requirements or for meeting the minimum requirements on hygiene and sanitation depending on the type of establishment. A separate FDA Circular on the application process requirements for the application for a COC using the same online system for e-LTO will be issued later for the reference of the cosmetic industry.

The FDA is now soliciting public opinions on the draft. You may leave your comments at the FDA Website or send it through email at [email protected] on or before 17 January 2020.