ANNEX A  
 
A. REQUIREMENTS FOR INITIAL LICENSE TO OPERATE APPLICATION  
 
1. eApplication Form through the FDA Available Online Application Platforms  
 
Among other information, the applicant shall provide the following information:  
a. Global Positioning System (GPS) coordinates  
b. Name of the Qualified Person, depending on the type of health product 
establishment as specified in Annex B  
 
2. Proof of Business Name Registration  
Any one of the following shall be submitted as proof of business name registration (in 
pdf):   
 
a. For single proprietorship, the Certificate of Business Registration issued by 
the Department of Trade and Industry (DTI);  
b. For Corporation, Partnership and other Juridical Person, the Certificate of 
Registration issued by the Securities and Exchange Commission (SEC) and 
Articles of Incorporation;  
c. For Cooperative, the Certificate of Registration issued  by the Cooperative 
Development Authority and Articles of Cooperation; or  
d. For Government -Owned or Controlled Corporation, the law creating the 
establishment, if wi th original charter, or its Certificate of Registration issued 
by the Securities and Exchange Commission (SEC) and Articles of 
Incorporation, if without original charter.  
 
3. When the business or establishment address is different from the business name 
regis tration address, the applicant shall submit a copy of the Business 
Permit/Mayor’s Permit, or Barangay Certificate with complete business address.  
 
4. Proof of Capitalization for Manufacturers, Traders, CROs, and Sponsors  
 
Proof of Capital Investment such as t he latest audited Financial Statement with Balance 
Sheet (in pdf) or duly notarized Statement/Certification of Initial Capitalization, for 
those newly -opened establishments shall be submitted. This is to verify the 
capitalization of the establishment to th eir corresponding application fees.  
 
5. The following documents shall be presented during inspection for examination or 
review, when required:  
 
a. Risk Management Plan (RMP)  for the following establishments:  
 
i. Manufacturers of drugs, medical devices, cosmetics, and household urban 
hazardous substances (HUHS) including household/urban pesticides 
(HUPs) and toys and childcare articles (TCCAs);  
ii. Medium and large food manufacturers;  
iii. Traders and Distributors (importers, exporters, and/or wholesalers) of 
drugs, medical devices, foods, cosmetics, and HUHS including HUPs and 
TCCAs  b. Site Master File (SMF) and floor plan/plant layout  for the following 
establishments:  
 
i. Manufacturers including packers and repackers of drugs, medical devices, 
cosmetics, and HUHS including HUPs and TCCAs;  
ii. Medium and large food manufacturers;  
 
6. For RONPD establishments with a pharmacist handling multiple RONPDs, list of all 
outlets including the Name of Establishment, Address, Day and Time of shift and LTO 
number.  
 
7. For Food Business Operators and Medical Device Retailers, Notarized Contract of 
Agreement/Appointment or Authorization Letter/Distributorship Agreement and 
Notarized Franchise Agreement provided that the following conditions are met:  
 
a. Notarized Franchise Agreement – The business name of the establishment 
reflected in the LTO shall be based on the trade name indicated in the 
Franchise Agreement. In addition, it must be consistent with the business name 
registration.  
b. Notarized Contract of Agreement – For appropriate determination of activit y 
that shall be indicated in the LTO, a copy of the Contract of Agreement is 
recommended to be submitted. The basis for the LTO activity shall depend on 
the legally binding contract agreement between the establishment and its 
client/supplier.  
 
8. Payment of a ppropriate fees.  
 
B. REQUIREMENTS FOR RENEWAL LICENSE TO OPERATE APPLICATION  
 
1. eApplication Form through the FDA Available Online Application Platforms  
 
Among other information, the applicant shall provide the following information:  
a. License Number and its validity date  
b. Security code as provided in the QR Code of current LTO Certificate or a 
sequence number located at the bottom right corner of the LTO Certificate.  
c. Contact Information  
 
1. For Food Business Operators, Financial Statement  
 
2. Payment of appropriate fees