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While there are quite a few articles online on FDA LTO application, they are mostly outdated.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.

The Complete FAQ Guide on How to Renew Your Business Permit in the Philippines for 2020

Having a business registered in the Philippines requires you to renew its business permits annually.

It doesn’t matter if the company is a Single Proprietorship, a One Person Corporation, a Partnership, a Corporation, a Branch Office, or a Regional Headquarter (ROHQ). All business establishments, per Philippine law, must renew their permits or face possible closure of their operations as well as a loss of face to their clients. 

To help you avoid long lines and heavy monetary penalties, we give you our complete FAQ guide on how to renew your business permit in the Philippines for 2020. 

Frequently Asked Questions (FAQs):

 

What permits do I need to renew? When is the deadline for each? 

Business permit renewal season involves coordinating with three different government entities: the barangay, the city or municipality, and the Bureau of Internal Revenue (BIR). 

1. Barangay Permit or Clearance (Deadline: January 20)

A barangay permit certifies that a business establishment is compliant with the requirements set by its local government unit (LGU) of operation. It is also a requirement when securing the Mayor’s Permit. 

2. Mayor’s Permit or Business License (Deadline: January 20)

Each city or municipality has its own rules to comply with. The Mayor’s Permit certifies that a company is compliant with the ordinances of the city or municipal it operates in. 

3. BIR Renewal of Registration (Deadline: January 31)

The BIR issues a Certificate of Registration (COR) to a company when it is first established. To ensure its validity from year to year, a business establishment must pay a renewal fee of PhP 500.00 every January 31.

 

What are the penalties for non-renewal or late renewal of business permits? 

City or Municipality

If filing is not accomplished by January 20 of each year, the LGU concerned will impose a 25 percent surcharge on top of the unpaid taxes, charges, and fees assessed. Also, a negligent company will incur a 2 percent monthly interest on all unsettled fees, including the surcharge, until everything is paid off.

Extremely delinquent businesses, on the other hand, run the risk of closure and/or seizure of its properties and assets.

All these penalties are imposed by the Local Government Code of 1991.

BIR

A company that did not comply to the January 31 deadline will be fined an amount ranging from PhP 5,000.00 to PhP 20,000.00. Its officers also face the risk of imprisonment, with the term ranging from six months to a maximum of two years. 

 

What requirements do you need for business permit renewal with each government office?

Barangay

1. 2019 Barangay Permit (original and photocopy)

2. Official Receipt from last year (original and photocopy)

3. Accomplished application form (2 copies)

4. Renewal fee (varies per barangay)

City / Municipality

1. 2020 Barangay Permit (to be availed first for the current year)

2. 2019 Mayor’s Permit (original copy)

3. 2019 Official Receipt (original copy)

4. 2019 Audited Financial Statement

5. Lease Contract (if changing address)

6. Community Tax Certificate (CTC) or Cedula (to be secured first from City or Municipal Hall)

7. Comprehensive General Liability Policy (CGLP) insurance for 2020

8. Official receipt of CGLP availed

9. Renewal fee (varies per city or municipality)

Depending on the LGU concerned, you may also be asked to provide the following documents:

1. Fire and Safety Inspection Certificate (original copy) 

2. Sanitary Permit (original copy)

BIR

1. BIR Payment Form 0605 (Click this link to download from the BIR website)

2. PhP 500.00 annual business registration fee

 

What are the steps for renewing business permits? How long will the process take? 

Barangay

Estimated Time Needed: 1 day

1. Visit the barangay hall in whose district your company operates in. Secure a renewal application form.

2. After filling out the form, submit it along with the original copies of your 2019 Barangay Permit and Official Receipt.

3. The barangay’s permit division will then assess your renewal application and documentary requirements. If everything is in order, you may then pay the necessary renewal fee.

4. You will be given the Official Receipt for your Barangay Permit. You may then claim your new Barangay Permit on the date indicated in the Official Receipt.

City / Municipality

Estimated Time Needed: 1 to 2 weeks

1. Secure a renewal application form from the Business Permits and Licensing Office (BPLO) of the LGU that your company operates in.

2. Fill out the form then submit along with the documentary requirements for evaluation.

3. Based on the submitted documents, the BPLO will issue an assessment notice containing the amount of local business tax, real property tax, and other fees that your company needs to pay for 2020. You can choose to pay the entire annual fee in full or in quarterly installments. You may also contest the amount and request a lower assessment. 

4. Bring the assessment notice and pay the required fees at the City Treasurer’s Office. They will provide you the Official Receipt to be presented when you claim the Mayor’s Permit certificate.

5. If your documents are in order, pay the Mayor’s Permit renewal fee at the City Treasurer’s Office. You will be given a receiving copy of your documents.

6. It will take some time for the certificate to be released. In the meantime, the Official Receipt will serve as proof that you renewed your Mayor’s Permit on time if asked. 

7. You may then claim your new Business License from the City Treasurer’s Office on the date indicated in the Official Receipt.

BIR

Estimated Time Needed: 1 day

1. Fill up BIR Payment Form 0605 with details of your business establishment.

2. Bring the BIR Payment Form 0605 to your RDO’s Authorized Agent Bank (AAB) and pay the PhP 500.00 annual business registration fee there.

 

What other tips should I know about business permit renewal?

1. Don’t procrastinate. Preparing the documents required by your LGU at the last minute will land you in long waiting lines and possible payment of penalties. Use the whole month of December if necessary. Remember: the deadline for the whole process of business permit renewal is January 20.

2. Be OC (obsessive-compulsive). Paying attention to small details can save you a lot of time. Organize your documents as soon as you receive or print them. Triple-check what is written in your application form and its attachments. Bring enough cash before you head to the battle lines. 

3. Patience is a virtue. No matter how early you start preparing, you will probably still face lines at your barangay hall, city hall, and BIR RDO. Make sure you’re ready to play the waiting game. Bring a fan, towel, bottled water, and even a good book if you’re so inclined.

4. Copies can save you. You never know how many copies of a particular document will be asked of you at the counter. Bring extra copies of your required documents so you don’t have to run out to the nearest photocopier (and lose your spot in the lines).

5. Avoid fixers. Do everything aboveboard. Don’t listen to individuals who promise shortcuts and discounts in the business permit renewal process. Their quick fixes may also quickly land you in hot water for tax evasion.

 

The best partner for renewing your business permit is someone who tells you the fees and steps needed exactly as it is. At DAYANAN Business Consultancy, we do exactly just that. Having helped over a hundred companies through the process, we know exactly how to save you time and effort. This allows you to focus on your core business functions better.

Let us take care of filling out forms and going to government offices for you. Contact us today!

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.