How to Apply for FDA LTO (License to Operate) in the Philippines

FDA LTO Application FDA Consulting in Makati

Interested in FDA LTO application (License to Operate from the Philippine Food and Drug Administration) but don’t know where to start? This new guide gives you a complete step-by-step process on how to apply for an FDA LTO in 2020.

While there are quite a few articles online on FDA LTO application, they are mostly outdated. One major change to the process is that it is now done online via https://eportal.fda.gov.ph (the integrated application form may be found here). Once processed and approved, the LTO will be mailed to you; no need to pick it up from regional FDA centers.

Click the links below to go directly to that part of this article:

  1. What is an LTO? Why would you need one?
  2. How to Apply for FDA eLTO User Account
  3. License to Operate Requirements
  4. Steps for FDA LTO Application
  5. Tips to make application easier and faster
 

What is an LTO or License to Operate? Why would you need one?

An LTO allows you to legally import, distribute, sell wholesale, and/or manufacture food, drugs, cosmetics, and medical devices. It is also a requirement before you can obtain a Certificate of Product Registration (CPR), a seal of approval which indicates that your product complies with health, safety, and technical standards set by the FDA in the Philippines.

Operating without a license can spell disaster for your business. If caught, your LTO may be suspended, revoked, canceled, or disapproved upon renewal. Likewise, existing licenses that were not renewed after one-hundred twenty (120) days from the date of expiration will be automatically canceled by the FDA. Not only that, but the company will automatically be delisted from the FDA’s list of licensed establishments, so be sure to renew on time.

Important Reminder: Only residents of the Philippines (either Filipino citizens or alien holders of resident visas) and majority Filipino-owned companies may apply for LTO.

All guidelines and penalties may be found on the FDA website: http://www.fda.gov.ph

 

How to Apply for FDA eLTO User Account

Per FDA Circular 2016-004 (Procedures on the Use of the New Application Form for License to Operate through the FDA Electronic Portal), the application process has been moved online. With the goal of increasing transparency, accessibility, and efficiency of the process, this decision has been especially beneficial for businesses based outside Metro Manila.

Before you can access the E-portal, you must first create a User Account, the application for which is not as straightforward as what you may be used to. Instead of a simple sign-up button, it instead involves sending a few emails. Here’s how to create a new User Account for the FDA E-Portal System:

  • First, accomplish an authorization letter for the eLTO User Account Application. This will designate a specific individual as eLTO account holder.
  • Next, send an email to request for a User Account to the FDA’s Public Assistance, Information and Receiving (PAIR) unit via pair@fda.gov.ph with the following format:
SUBJECT: Request for eLTO User Account

BODY:

a. E-mail address (preferably company email address)
b. Name of the authorized company representative (preferably permanently employed and not merely a consultant)
c. Position in the company
d. Contact Number
e. Company Name
  • Don’t forget to attach a scanned Authorization Letter in PDF format. Be sure that it is completed (signed and notarized) and virus-free.

Below is a sample email provided by the FDA:

From: https://ww2.fda.gov.ph/attachments/article/330042/FDA%20Circular%20No.%202016-004.pdf

Please take note that the User Account details will be sent to the company email address provided in the body of the email, not to the original sender’s email address. User Accounts are usually issued within two (2) days upon receipt of the completed request by the FDA in the Philippines. Requests received after 5:00 pm on regular working days, holidays, Saturdays, and Sundays shall be processed on the next working day.

Each User Account is unique to one company and is valid for one (1) year. Requests for replacing the authorized company representative as well as account reactivation must be sent to pair@fda.gov.ph at least three (3) months before the expiration of the User Account.

Once you have a valid User Account in hand, the E-Portal can now be accessed. Filling up the forms and uploading the documents can now be done via the portal. The E-Portal accepts new, renewal, and variation applications.

The accomplishment of the eLTO may be done via http://www.fda.gov.ph.

License to Operate Requirements

The following are the License to Operate requirements for initial and renewal applications. Ensure that all documents are secured before applying to avoid processing delays.

FDA LTO Initial Requirements:

  • Completed Application Form with Declaration and Undertaking
  • Proof of Business Name Registration
  • Risk Management Plan
  • Site Master File (for manufacturers of drugs, devices and cosmetics)
  • Fees payment

FDA LTO Renewal Requirements:

  • Completed Application Form with Declaration and Undertaking
  • Payment of fees

Now that you have all the requirements, the application for the actual license can now follow.

Steps for FDA LTO Application

Applying for an initial FDA LTO consists of the following steps: filing, evaluation, and inspection. An application is considered filed only if all necessary requirements are met, including payment of fees. After filing, the FDA will evaluate all LTO applications to determine whether to grant the license or not. Lastly, a pre-opening inspection shall be conducted for manufacturers. In addition, all establishments covered under the FDA may be inspected anytime by the agency to ensure proper compliance with its set rules and regulations.

  • Log-in to the e-Portal using the User Account provided by FDA at http://www.fda.gov.ph.
  • Click “New Case” on the upper left-hand side and select “License to Operate v2.0” which can be found under Electronic Licensing.
  • Make sure you’ve read and fully understood the “Declaration and Undertaking” and click the “I Agree” button before proceeding.
  • Under the General Information tab, select the appropriate Product Type, Primary Activity, and Type of Application from their respective drop-down menus.
  • (Each primary activity has its applicable sub-options. Accomplish the General Information appropriately).
  • Under Establishment Information, provide the complete establishment name, TIN, address, and contact details. Use the Show Map Tool and move the arrow to the exact address of the establishment and click the “Submit” button.
  • Provide needed information under “Details of the Authorized Officer” and “Details of the Applicant.”Upload the required documents (depending on LTO type). Make sure documents are in PDF format.
  • Double-check the total amount to be paid by looking at the Order of Payment section, which can be downloaded if needed.
  • Payment can be made using existing FDA mechanisms.
  • Please note: Under the “Assign Task” section, please click the “Continue” button in order for the application to be processed by the FDA.

Here are some tips to make application easier and faster:

Tip 1: Follow documentary requirements listed in Administrative Order (AO) 2016-0003 (“Guidelines on Unified Licensing Requirements and Procedures of the Food and Drug Administration”):

  • Submit files in PDF format and ensure that there are no bugs, viruses, or anything that can jeopardize the system of the FDA.
  • All documents must be scanned and compiled with 100-150 dots-per-inch (dpi).
  • All document file names must be less than 40 characters, should not contain the following characters: \ ? / : * ” > <

Tip 2: Make sure to submit all forms completely. Do not forget to attach files to emails before sending them.

Tip 3: Get assistance from DAYANAN Business Consultancy! With our FDA Consulting services, you would no longer have to stress and fret over the LTO application process.

After you’re done applying, expect your FDA License to Operate (LTO) in the mail! We hope these tips answer your queries on how to apply for an FDA LTO. If you would like to avail of our FDA consulting services, you may contact us here.

FDA Consulting

The Food and Drug Administration (FDA) is the Philippine government agency charged with ensuring the quality and safety of the following products:

  • Processed food and drinks
  • Drugs and other pharmaceutical products
  • Dietary/herbal supplements
  • Medical devices
  • Cosmetics
  • Toys and child care articles
  • Household pesticides/cleaning agents
  • Veterinary products
  • Animal Feeds

In line with its mandate under the Department of Health (DOH), the FDA regulates the production, importation, and distribution of these products in the country.

A company that wishes to engage in such business activities must first obtain a License To Operate (LTO) from the FDA either as an importer or a manufacturer. Once done, the company must then apply for a Certificate of Product Registration (CPR) to ensure that its products comply with FDA technical standards.

DAYANAN can serve as primary liaison between your company and the FDA. Our familiarity with the regulatory framework and proactive approach will help ensure faster turnaround on your application. We will also link your company to laboratories recognized by the FDA to perform various required analytical tests on your products.

HR Consulting

A company’s most important resource is its people. To fully harness their productivity and avoid labor issues, your human resources system must be up to par. DAYANAN can help strengthen your existing HR infrastructure or even set it up from scratch.

We offer the most comprehensive HR Templates Pack optimized to Philippine labor conditions and regulations. The package includes the following:

  • Employee Handbook
  • Compensation Details
  • Proprietary Information and Confidentiality
  • Application for Employment
  • Probationary Employment Contract
  • Probationary Evaluation Form
  • Notice of Termination of Probationary Employment
  • Regularization Letter
  • Release Waiver and Quitclaim
  • Trainee Contract
  • Equipment Release Form
  • Certificate of Employment
  • Certificate of Employment and Compensation
  • SL-VL form
  • Employee Clearance
  • DOLE-Required Policies:
    • Alcohol-free Workplace
    • Drug-free Workplace
    • Hepatitis B
    • HIV / AIDS
    • Sexual Harassment
    • Smoke-free Workplace
    • TB

These documents come with our guarantee of iron-clad provisions that uphold employee rights while protecting businesses from legal liabilities. We can further customize these documents according to your company’s needs.

DAYANAN also provides ongoing HR support such as guidance on relevant laws, resolution of employee issues, and implementation of company-wide policies. Contact us today and get started on your way to HR success.

The Apostille: Simpler Authentication for Documents To Be Used Abroad

HCCH

Bringing documents from one state to another and having their validity recognized has always been difficult. A foreign corporation that wants to establish a Philippine subsidiary has to go through several steps just to authenticate its articles of incorporation from abroad. But with the Philippines recently joining the Apostille Convention, things are bound to get easier.

The Convention

The Apostille Convention (formally known as the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents) provides for the use of a security certificate called the “Apostille.” This simplifies the authentication process for public documents used across signatory countries. The Philippines officially became a member last September 12, 2018.

Drafted by the Hague Conference on Private International Law (HCCH), the international treaty will take effect between the Philippines and other states party to it on May 14, 2019. This is pending changes to be made by the Supreme Court to the Rules of Court with regards to foreign public documents. The Office of Consular Affairs under the Department of Foreign Affairs (DFA) will be responsible for implementing the treaty.

The Apostille

Previously, a public document must be authenticated both by the foreign ministry of its originating country and the foreign ministry of the country where it is to be used. This process is usually handled by embassies and consulates of the concerned states. In the Philippines, the certification issued by the DFA is popularly called the “red ribbon.”

Once the Convention becomes effective, public documents would no longer need to be consularized. An apostillized public document will immediately have legal effect in a foreign country where it is presented. Of course, the affixing of a red ribbon is still needed for states which are not members of the Convention.

The apostille is a standard form that can be placed or attached to the original document. It testifies that a document bears the signature of an authorized person, the capacity of the signatory, and an official stamp or seal. It does not, however, certify the content or purpose for which the document was issued.

Covered Documents

Public documents that can be apostillized according to the Convention are the following:

a) documents emanating from an authority or an official connected with the courts or tribunals of the State, including those emanating from a public prosecutor, a clerk of a court, or a process-server (“huissier de justice“)

b) administrative documents

c) notarial acts
       Note: This may include seemingly “private” documents such as contracts and wills

d) official certificates which are placed on documents signed by persons in their private capacity, such as official certificates recording the registration of a document or the fact that it was in existence on a certain date and official and notarial authentications of signatures.

Those that are not valid for apostillization include:

a) documents executed by diplomatic or consular agents;

b) administrative documents dealing directly with commercial or customs operations.

 

The apostille, once it is fully implemented in the Philippines, can boost trade and investment while making personal transactions easier. It will be useful for the millions of Filipinos working abroad as well as the large number of expatriates who have made (or are planning to make) the Philippines their second home.

Business Consultant Philippines

Success in the Philippines depends on choosing the right business consultant to assist you in studying the Philippines market and developing the correct market entry strategy.

Starting and doing business in the Philippines requires information and knowledge.

DBC specializes in helping foreign companies acquire the specific facts they need to establish their office and find clients and partners. Introduce you to the necessary government agencies to obtain business permits and apply for tax incentives.

Business Plan Consultancy

Whether you are a local or international company DBC’s team of professional consultants has the required expertise to prepare comprehensive Feasibility Studies, Business Planning, Market Entry Strategy Reports, Market Research and Real Estate Development Market Studies.

Business Registration Consultant

DBC has assisted many local and foreign businesses, who wish to start doing business in the Philippines in completing their company registration requirements. Organizing all that is needed to have your Philippines business registration accomplished smoothly and rapidly with the required government agencies. Most companies will need to apply or register with the SEC, DTI, BIR, SSS, Pag-IBIG, and PhilHealth. DBC will explain the different company structures available in the Philippines and advise you on the advantages of each one.


Let DBC be your business consultant in the Philippines