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While there are quite a few articles online on FDA LTO application, they are mostly outdated.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:
- What is an LTO? Why would you need one?
- How to Apply for FDA eLTO User Account
- License to Operate Requirements
- Steps for FDA LTO Application
- 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 companies incorporated in the Philippines 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.
