All comments can be sent at [email protected]. Deadline of submission of comments shall be by 25 March 2021.
I.BACKGROUND
In order to gear towards an efficient operationalization of Food and Drug Administration (FDA) regulatory systems, various technological thread and digital structures were developed. Alongside this development is the current enhancement of FDA information systems which was also embodied in the mandate of Republic Act (RA) No. 11032 or the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”. Hence, EODB Act of 2018 aims to promote a more streamline and uncomplicated government transactions through the automation of business-related applications and procedures. Moreover, with the issuance of Administrative Order (AO) No. 2020-0017 or the “Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA Repealing AO No. 2016-0003”, the establishment of FDA eServices Portal System as an online licensing platform is further advanced.
Compliant with the mandate of RA No. 8792 or the “Electronic Commerce Act of 2000” and AO 2020-0017, the eServices Portal System other than providing a simplified application for clients, also adopts the whole-of-government approach in improving the regulatory management of the FDA in terms of business permitting and licensing processes.
In this light, the FDA eServices Portal System has been developed to provide a streamlined online platform for FDA Authorization applications. Through this Circular, the FDA eServices Portal has also been updated to include LTO applications of Traders and Distributors including Wholesalers, Importers, and Exporters of processed food products, food supplements, bottled water, and iodized salt.
II. OBJECTIVE
The objective of this Circular is to provide the guidelines on the new FDA eServices Portal System in applying for LTO applications of Traders and Distributors including Wholesalers, Importers, and Exporters of processed food products, food supplements, bottled water, and iodized salt.
III. SCOPE
This FDA Circular shall cover the following LTO applications:
A. Types of Establishment:
- Traders; and
- Distributors (Wholesalers/Importers/Exporters)
B. Types of Health Products:
- Processed Food Products;
- Food Supplements;
- Bottled Water and;
- Iodized Salt
C. Types of LTO Application
- Initial;
- Renewal; and
- Variation
IV. DEFINITION OF TERMS
The terms used in this Circular shall have the same definition as prescribed in RA 9711 and its Implementing Rules and Regulations (IRR), AO No. 2020-0017, and other applicable laws and regulations.
V. GUIDELINES
A. The General and Specific Guidelines on the application for LTO as indicated in AO No. 2020-0017 shall be adopted and expounded in this FDA Circular.
By applying for an FDA LTO, the establishment understands and abides by the rules and regulations set forth by the Agency. The establishment shall have the ultimate responsibility as to their compliance to national and/or international standards of safety, quality, purity, and efficacy of health products they provide to the consumers and the general public.
B. Application Requirements
Based on AO No. 2020-0017, the requirements that follow must be submitted.
- Initial Application
a. Accomplished eApplication Form with Declaration of Undertaking
i. Location Plan;
ii. Global Positioning System (GPS) Coordinates; and
iii. Name of Qualified Person, depending on the type of health product establishment
b. Proof of Business Name Registration (in pdf, 2MB maximum file size) shall be submitted in any of the following:
- For single proprietorship, the Certificate of Business Registration issued by the Department of Trade and Industry (DTI);
- For Corporation, Partnership and other Juridical Person, the Certificate of Registration issued by the Securities and Exchange Commission (SEC) with complete Articles of Incorporation.
- For Cooperative, the Certificate of Registration issued by the Cooperative Development Authority (CDA) and Articles of Cooperation; or
- For Government-Owned or Controlled Corporation, the law creating the establishment, if with original charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation, if without original charter.
c. For Food Trader, proof of income (in pdf, 2MB maximum file size) such as the latest audited Financial Statement with Balance Sheet (in pdf) shall be submitted. This is to verify the capitalization of the establishment to their corresponding application fees. For newly established companies that have no Financial Statement yet, duly notarized Statement/Certification of Initial Capitalization must be submitted.
d. Payment of Fees based on the latest FDA issuance.
e. Business Permit (e.g., LGU/Mayor’s Permit, Barangay Business Clearance/Permit – if the business establishment address is different from the business name registration address.
- Renewal Application
a. Accomplished eApplication Form with Declaration of Undertaking; and
b. Payment of Fees based on the latest FDA issuance.
- Variation Application
a. Accomplished eApplication Form with Declaration of Undertaking;
b. Documentary requirements depending on the type of variation or circumstances of the establishment or product as shown in the table below;
| Type of Variation | Document Requirement |
| Transfer of Location of Offices
– Physical transfer of the office of the establishment |
Business permit reflecting new location office |
| Change of Distributor Activity
– Addition/change in activity that the distributor engages in |
Contract Agreements showing change in activity |
| Transfer/Addition of Warehouse
– Physical transfer and addition of warehouse of the establishment |
Business permit reflecting new warehouse |
| Change of Ownership
– Change in ownership of the licensed establishment |
a. Business name registration reflecting new ownership
b. Any proof on the transfer of ownership such as any of the following: i. Deed of sale or assignment or transfer of rights/ownership ii. Memorandum of Agreement; or iii. Notarized Affidavit of the owner, proprietor, Chairman or CEO of the establishment validating the transfer |
| Change of Business Name | Business permit reflecting the new name |
| Zonal Change in Address
– Change of the name/number of the street/building without physical transfer of the establishment |
Certificate of Zonal change |
| Change of Qualified Person
– Change in the identified qualified person initially registered with the FDA |
Name of new qualified person and the corresponding requirements |
| Change of Authorized Person
– Change in the authorized person initially registered with the FDA |
a. Name of new authorized person |
c. Payment of Fees based on the latest FDA issuance.
C. Qualification and Credential Requirements of the Qualified Person
| Qualification | Training Requirement |
| Company Regulatory Officer (Authorized Person) and Food Safety Compliance Officer who is preferably a graduate of food-related courses including but not limited to food technology, food and nutrition, chemistry, microbiology, chemical/sanitary engineering, veterinary medicine, fisheries, agriculture (RA 10611) | Certificate of Attendance on seminar on food safety, GMP or HACCP given by the academe, WHO, FAO, NGOs, cooperative, food industry organizations, professional organizations, or the FDA Academy |
D. Application Process
- The application shall be filed online through the eServices Portal website fda.gov.ph/. The creation of account and password is no longer a requirement to obtain access to the eServices Portal.
- The applicant is expected to read and agree with the “Declaration and Undertaking” in order to continue with the application. Such conveys a binding agreement of the applicant company with the FDA to provide accurate information, affirm primary responsibility over the products, and comply with all the rules and regulations set forth during and after the application process. Any false misrepresentation of the information in this application shall be subjected to administrative and criminal liabilities provided by RA 9711, which includes, but not limited to suspension, cancellation, or revocation of the LTO.
- In filling-up the fields in the eApplication form, the applicant will be assisted with written warnings/pop-ups/reminders before proceeding to the next step to ensure accuracy of the information being provided. The establishment applying for LTO shall ensure that the declared information in the eApplication form is consistent with the uploaded supporting documents, e.g., establishment name and owner, establishment’s address, and others.
- The declared e-mail address under the Contact Information is unalterable. Hence, the applicant shall be responsible in making sure that the e-mail address is within the scope and access of the Authorized Person/s, Qualified Personnel, and/or owner of the establishment. The FDA shall not be held liable in any way for loss of access to the declared e-mail address.
The Company Authorized Officer or Qualified Personnel shall have the responsibility to comply with the regulatory and technical requirements of the FDA wherein:
a. The Authorized Person refers to the owner, President, Chief Executive Officers (CEO) or its equivalent, or any organic or full-time employee representing the establishment in an authorized or official capacity; and
b. The Qualified Person 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, or experience. A Qualified Person has the responsibility to comply with the technical requirements of FDA or discuss/clarify matters with the FDA when submitting technical requirements or engage the FDA Officials when conducting inspection or post-market surveillance activities. The Qualified Person may also be the duly Authorized Person of the establishment.
- Documents required to be uploaded in the eApplication form shall be in portable document file (PDF), with no more than 2 megabytes (MB) file size.
- Variation and renewal applications must be applied separately. If a Food Product Establishment is due for renewal, but is expected to apply for changes in information that need to be reflected in the system or registry, then a renewal application must first be submitted.
The clients should be informed that the LTO to be issued upon renewal will reflect the previous information and the updating should be done through filing of a separate variation. In addition, the clients cannot apply for a renewal of application if not within ninety (90) days before the expiration date of the LTO.
- Once the eApplication Form is completed, applicants can review the duly filled out form in the Self-Assessment Review. By agreeing to the terms and conditions, the applicant confirms to the correctness of information provided and data privacy terms.
- The Application Summary shall be automatically sent to the applicant’s registered e-mail address to indicate the successful submission of the application in the eServices Portal.
- For applications filed through the FDA eServices Portal System, there shall be a change in the format of LTO number as such;
Old: 300000XXXXXX
New: CFRR-(Region)-(Activity)- (Sequence Number)
- All technical specifications of food products for importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship are provided and based in AO No. 2014-0029 (Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and other Food Products, and for other Purposes).
- Applications filed after the prescribed working/office hours or during weekends and holidays shall be considered filed on the next working day.
- The status of the application can be monitored at the eServices website by validating through the e-mail address used for the application.
- Establishments with existing LTO applications via ePortal may opt to apply to the eServices Portal for a new fee. Previous payment will be forfeited as the filed applications are already in-process.
- FDA inspection shall be conducted after the issuance of the LTO as Food Distributor and Food Trader (post-licensing approval).
- The FDA shall have the authority to enter any FDA-licensed establishments selling FDA-regulated health products during operating hours to conduct routine or spot check inspections.
(The step-by-step procedure in the eServices Portal is attached as Annex in this issuance)
- E. Pre-assessment
- An FDA evaluator/assessor shall conduct a pre-assessment on the submitted application and documentary requirements with regards to their completeness and correctness. Applications with incomplete or incorrect data entries and document submissions shall not be accepted and the application will not proceed to the next step of the process.
- The Pre-assessment of applications shall be done within the prescribed working days and office hours of the FDA.
- The FDA shall inform the applicant through the registered e-mail address of the result of the pre-assessment. If the application passed the pre-assessment step, the applicant shall receive the Order of Payment with Reference Number through e-mail indicating the fees to be paid. However, if the application did not pass the pre-assessment step, the FDA shall notify the reason/s for non-acceptance e.g., deficiency/ies found and prompt the applicant to apply again through the eServices Portal.
F. Payment of Fees
- The payment of the total application fee as indicated in the Order of Payment (OP) maybe done through Over-the-counter (OTC) payment at FDAC, On-coll payment at Land Bank of the Philippines (LBP) branches, or online payment thru Bancnet (including LBP bills payment), based on the existing FDA issuances. The clients should always indicate the reference number reflected in the OP when paying through FDA available online payment channels. Otherwise, when transacting through over-the-counter payment method, the print-out OP should be endorsed to Cashier Officer for the processing of payment. Clients will be informed of other available channels of payment through an FDA issuance.
- Once the payment is made, the payment channel -LBP or Bancnet (except for OTC at FDAC) will send a transaction report to FDA which usually takes a minimum of two (2) days. Upon receipt of the report, the Cashier Section checks the details and posts the payment in the eServices Portal if payment is made in full. Posting of payment may take a maximum of two (2) days, depending on the volume of paid applications received.
- Incomplete payment (amount paid is less than that of OP amount) will not be posted until the full amount as indicated in OP is settled. As such, applications with incomplete or unsettled payments will not proceed to the next step of the process.
- Applicants will receive a system-generated message through the registered email address on the status of the payment made once posted or need further settlement. If full payment is made, the e-mail will contain Acknowledgment Receipt, otherwise, a notification on payment deficiency.
G. Approval of the Application
- The veracity of the application and compliance with all relevant FDA requirements and standards shall be checked.
- The applications with complete documentary requirements and payment, shall receive an Acknowledgement Receipt from FDA, containing the Evaluator’s number/code who received the application, reference number, agency logo, the date and time of application, payment, and the statement of completeness of the documents submitted. An application is considered filed once the applicant receives the Acknowledgement Receipt.
- If the application is approved, the FDA shall send the LTO to the registered e-mail address of the applicant. If the application is disapproved, the FDA shall inform the applicant through its registered e-mail address of the reason for such action on the application.
H. Disapproval of Application
- For emphasis, the grounds for disapproval of LTO application may be any of the following, as stated in A.O No. 2020-0017:
a. the documentary requirements submitted show that the establishment does not meet the required technical requirements and/or appropriate standards;
b. absence of physical office upon inspection, without permission or approval from FDA;
c. the applicant made misrepresentations, false entries, withhold relevant data contrary to the provisions of the law or appropriate standards;
d. the owner has violated any of the terms and conditions of its license; and
e. such other analogous grounds or causes as determined by the FDA.
The disapproval of an application is without prejudice to re-application. However, disapproval shall mean outright forfeiture of payment.
I. Release of LTO
- The applicant shall receive the LTO in their registered e-mail address and may also be accessed through the FDA eServices Portal.
2. Upon receipt of the LTO, the establishments shall print the LTO on a standard A4 size (21 cm x 29.7 cm) paper, on full-colored page and in portrait orientation. It shall be positioned on the most conspicuous place within the business establishments.
3. A QR Code verifier shall be included in the LTO as basis of legitimacy of the document.
4.For Variation, the applied variation shall automatically be reflected on the LTO. An updated LTO shall be provided to the registered e-mail address of the applicant.
V. REPEALING CLAUSE
Issuance, rule and regulations on the LTO application for Food Trader and Food Distributor including Wholesaler, Importer, and Exporter of food products found inconsistent with the provisions of this Circular is hereby amended or repealed accordingly.
VI. EFFECTIVITY
This Circular shall be effective immediately.
Attachment:-> Guideline for the Use of the Food and Drug Administration
Attachment:->Procedure for the use of the FDA eServices Portal System for License to Operate Application