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I. BACKGROUND

 

In order to build efficient regulatory systems, the Food and Drug Administration (FDA) has undertaken process improvement initiatives, including the establishment of information and communication technology infrastructures and digital systems. Such initiatives were further driven by Republic Act (RA) No. 11032 or the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018”. The said law aims to promote streamlined government transactions through digitalization and automation of business-related applications and procedures.

Consistent with the afore-mentioned initiatives, the RA No. 11032, and RA No. 8792 or the “Electronic Commerce Act of 2000”, the FDA issued 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”, which established the FDA eServices Portal System as an online licensing platform for License to Operate (LTO) applications of health product establishments.

Through this Circular, the FDA eServices Portal is hereby updated to include LTO applications for Food Traders and Food 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 FDA eServices Portal System in applying for LTO applications of Food Traders and Food 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 Establishments:

  1. Food Traders; and
  2. Food Distributors (Wholesalers/Importers/Exporters)

B. Types of Health Products:

  1. Processed Food Products;
  2. Food Supplements;
  3. Bottled Water and;
  4. Iodized Salt

C. Types of LTO Application

  1. Initial;
  2. Renewal; and
  3. 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 are hereby expounded in this FDA Circular.

By applying for an FDA LTO, the applicant understands and abides by the rules and regulations set forth by the Agency. The establishment shall have the ultimate responsibility and accountability with compliance to national and/or international standards of safety, quality, purity, and efficacy of processed food products they provide to the consumers and the general public.

      B. Application Requirements

   Based on AO No. 2020-0017, the following requirements must be submitted.

  1. Initial Application

a. Accomplished eApplication Form with Declaration of Undertaking (provided in the eServices Portal System)

i. Location Plan;

ii. Global Positioning System (GPS) Coordinates; and

iii. Name of Qualified Person, depending on the type of food product establishment (Refer to Annex B of AO No. 2020-0017 for Qualified Person Qualification and Credential Requirements)

b. Proof of Business Name Registration

Any of the following shall be submitted as proof of business name registration:

       i. For single proprietorship, the Certificate of Business Registration issued by the Department of Trade and Industry (DTI);

ii. For corporation, partnership, and juridical person – Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation;

iii. For Cooperative, the Certificate of Registration issued by the Cooperative Development Authority (CDA) and Articles of Cooperation; or

iv. 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. Proof of Capitalization or Proof of Income, as applicable

i. For Food Traders, proof of income/capitalization, such as a copy of the latest audited Financial Statement with Balance Sheet declaring the capital, shall be submitted. This shall be used to verify the capitalization of the establishment for the proper computation of application fees.

ii. For newly established companies that have no Financial Statement (FS) yet, Statement/Certification of Initial Capitalization must be submitted signed by the owner and/or accountant. Upon renewal, the audited Financial Statement with Balance Sheet shall be required.

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.

f. Additional requirements, as applicable:

i. Franchise agreement – For franchises, a copy of the Franchise agreement is recommended to be submitted. The business name of the establishment reflected in the LTO shall be based on the trade name indicated in the franchise agreement. In addition, this must be consistent with the business name registration

ii. Contract of agreement – For the appropriate determination of activity to 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 applicant and its client/supplier

  1. Renewal Application

a. Accomplished eApplication Form with Declaration of Undertaking; and

b. Payment of Fees based on the latest FDA issuance.

  1. Variation Application

a. Accomplished eApplication Form with Declaration of Undertaking; and

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 Proof of Business Name Registration reflecting 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

Name of new authorized person and updated contact details

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

A step-by-step procedure in the eServices Portal is attached as Annex to this issuance.

  1. The application shall be filed online through the eServices Portal website fda.gov.ph/. The creation of an account and password is no longer a requirement to obtain access to the eServices Portal.
  2. The authorized officer or qualified personnel of the applicant establishment is expected to read and agree with “Declaration and Undertaking” in order to continue with the application. Such action 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.
  3. In filling-up the fields in the eApplication form, the authorized officer or qualified personnel of the applicant establishment 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.
  4. The declared e-mail address under the Contact Information is unalterable. Hence, the applicant shall use the company e-mail address. It shall also be 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. In the event that the e-mail address will be changed, a written notification specifying the new e-mail address and the reason for the change shall be submitted to [email protected]

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.

  1. 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.
  2. 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. Upon filing of application, the applicant should declare the LTO number of its most recently issued LTO for the system to generate an updated information of the establishment. (Please see attached Annex B for the sample LTO format).
  3. 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, after the issuance of an LTO following a successful renewal application. In addition, the clients cannot apply for a renewal of application if not within ninety (90) days before the expiration date of the LTO.
  4. Establishments with a valid LTO issued via ePortal System shall be honored and, consequently, are strongly advised not to file for an initial LTO application in the eServices Portal System.
  5. 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.
  6. 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.
  7. For applications filed through the FDA eServices Portal System, there shall be a change in the format of LTO number as follows:

Old: 300000XXXXXX

New: CFRR-(Region)-(Activity)- (Sequence Number)

  1. 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).
  2. Applications filed after the prescribed working/office hours or during weekends and holidays shall be considered filed on the next working day.
  3. The status of the application can be monitored at the eServices website by validating through the e-mail address used for the application.
  4. Establishments with existing/on-going LTO applications via ePortal may opt to apply to the eServices Portal for a new fee provided that the existing eLTO- application is cancelled in writing. However, the previous payment in the ePortal will be considered forfeited, as the filed applications shall be disapproved upon cancellation of the applicant establishment.
  5. FDA inspection shall be conducted after the issuance of the LTO as Food Distributor and Food Trader (post-licensing approval) based on the schedule of the concerned FDA Regional Field Office. For guidance during post licensing inspection, the client may refer to FDA Citizen’s Charter posted on the FDA website at fda.gov.ph.
  6. The FDA shall have the authority to enter any FDA-licensed establishments distributing, trading, and/or selling FDA-regulated food products during operating hours in order to conduct routine or spot check inspections, based on the provisions of RA 9711.

E. Pre-assessment

  1. 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 documentary requirements and/or inconsistent data entries with submitted documentary requirements based on existing FDA rules and regulations shall not be accepted and the application will not proceed to the next step of the process.
  2. The Pre-assessment of applications shall be done within the prescribed working days and office hours of the FDA.
  3. The eServices Portal System shall automatically send a notification on the result of pre-assessment through the registered e-mail address of the applicant.

a. 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.

b. However, if the application did not pass the pre-assessment step, the eServices shall notify the reason(s) or deficiency(ies) found and prompt the applicant to apply again through the eServices Portal using a new case number. The old case number of disapproved applications for pre-assessment is considered closed.

F. Payment of Fees

  1. Payments shall be made only after receiving the Order of Payment (OP).
  2. The payment of the total application fee as indicated in the 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. Once available, other payment channels will be announced through a separate FDA issuance.

a. The clients should always indicate the reference number reflected in the OP when paying through FDA available online payment channels.

b. 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.

  1. Once the payment is made, clients are advised that payments are processed and transmitted to the FDA by the payment channel – LBP or Bancnet (except for OTC at FDAC) after at least two (2) banking days. Upon receipt of the bank transaction report, the Cashier Section validates and posts the payment in the eServices Portal, when the payment is confirmed to be made in full. Validation and posting of payment may take a maximum of two (2) days, depending on the volume of paid applications received.
  2. The processing time of LTO applied through the eServices Portal System, in accordance with the FDA Citizen’s Charter shall start once the FDA Cashier has posted the Official Receipt of payment.
  3. Incomplete payment (i.e., amount paid is less than that indicated in the OP) 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.
  4. Applicants will receive a system-generated message through the registered email address on the status of the payment made. An Acknowledgment Receipt will be sent if full payment is confirmed to have been made. Otherwise, a notification on payment deficiency will be sent.

G. Approval of the Application

  1. The veracity of the application and compliance with all relevant FDA requirements and standards shall be checked.
  2. The applications with complete documentary requirements and payment, shall receive an Acknowledgement Receipt from FDA, containing the Evaluator’s number/code who processed the application, reference number, 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.
  3. The result of the application shall be sent to the applicant’s registered e-mail.

a. If the application is approved, the applicant shall receive the LTO, which will be printed by the applicant in accordance to the provisions in Section I below.

b. If the application is disapproved, the applicant shall receive a letter of disapproval, which provides the reason(s) for disapproval of such action on the application.

H. Disapproval of Application

  1. The grounds for disapproval of LTO application may be any of the following, as stated in AO No. 2020-0017 and AO No. 2014-029;

a. Failure to submit clear, complete, or compliant documentary requirements;

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;

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

  1. The applicant shall receive the LTO through their registered e-mail address. The copy of the LTO 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. The printed LTO shall be positioned on the most conspicuous place within the business establishments.
  3. A QR Code verifier shall be included in the LTO as means of confirmation of the legitimacy of the document.
  4. For Variation requiring changes in details of the previously issued LTO (e.g. Change of business name, additional activity), the applied variation shall automatically be reflected on the LTO. An updated LTO for printing shall be provided to the registered e-mail address of the applicant.

VI. SEPARABILITY CLAUSE

       If any part or term of provision of this Circular shall be declared invalid or unenforceable the validity or enforceability of the remaining portion or provision should not be affected and this Circular shall be construed as it did not contain the particular invalid or enforceable part, term or provision.

VII.     REPEALING CLAUSE

      Issuances, rules, and regulations on the LTO applications for Food Trader and Food Distributor including Wholesaler, Importer, and Exporter of food products found inconsistent with the provisions of this Circular are hereby amended or repealed accordingly.

VIII.    EFFECTIVITY

       This Circular shall be effective immediately.

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