A Quick Guide Towards Acquiring a License to Operate from the FDA - Blog

Apart from acquiring permits to officially operate your business within the country, there is another step that entrepreneurs must undertake to import, export, distribute, sell, and manufacture certain products that require further regulation. Chief among these are food and medicinal drugs, tracked by the Food and Drug Administration (FDA) under the Department of Health (DOH).

To begin business transactions for your products, you must acquire a Certificate of Product Registration (CPR) from the FDA. But before doing that, you must first secure a license to operate (LTO).

If you are running any of the two types of establishments described in the Guidelines on the Unified Licensing Requirements and Procedure of the FDA (Administrative Order No. 2016-003), you would have to secure an LTO:

Manufacturers, traders, and distributors (importers, exporters, and wholesalers) of processed foods, drugs (i.e., vaccines, biologics, veterinary drugs, and products), cosmetics, medical devices, in-vitro diagnostic devices and reagents, household/urban pesticides, toys, and child care articles
Drugstores/pharmacies/boticas (including hospital pharmacies and institutional pharmacies) and retail outlets for non-prescription drugs (RONPD)

For a detailed guide on how to acquire an LTO, proceed below.

— — — — —

STEP 1. Secure the Necessary Prerequisite Permits

For both manufacturers and distributors (dealing with exports, imports, and wholesale), it is important first to acquire the following documents:

Articles of Incorporation/Partnership (for cooperatives and corporations)
Certificate of Business Name Registration with DTI (for sole proprietorship)
Certificate of Registration issued by the Cooperative Authority (for cooperatives)
Certificate of Registration with SEC (for corporations)

Along with these, you must also present the following to the FDA::

Accomplished Application Form and Declaration and Undertaking
Certificate of Attendance to an FDA-sponsored seminar on licensing of establishments
Joint Affidavit of Undertaking
Location plan and Global Positioning System (GPS)
Name of the Qualified Person depending on the type of health product establishment; PRC ID
Proof of income (Last Audited Financial Statement with Balance Sheet) or Duly Notarized Statement/Certificate of Initial Capitalization

Most of the documents required for submission are to attest your company’s willingness to adhere to the guidelines set by the FDA to ensure the products you hope to put out for business are and will not be a danger to the public’s health and safety.

Ensure the validity of the listed requirements before moving on to the next step.

STEP 2. File Your Application for an LTO

Due to the modern technology we have today, business owners can now easily file their applications online!

Visit the FDA’s eServices Portal — a new online application system for miscellaneous FDA authorizations, such as an LTO and a Certificate of Product Registration.

On the application page, click the link for acquiring an LTO. Here, you will choose your business’ type of establishment based on the product you are handling.

One of the choices is dedicated to bottled water. Upon clicking the thumbnail, you will find yourself on another page where you will choose whether you are acquiring as a distributor or trader. It is also here where you can check the status of your application and cancel it if you want.

Fill out the necessary information and make sure that they are correct.

As is written in Administrative Order No. 2016-003, any form of falsification or misinformation will be dealt with swiftly. Apart from your application being rejected, you and your company can potentially be investigated.

Upon discovering any malpractice, the appropriate charges will be filed, and additional penalties will be imposed.

STEP 3. Pay the Necessary Fees for the Transaction

Depending on your product, you would have to pay the necessary fees for the application.

Only when the payment is submitted will your application be deemed complete. So, you must pay the fees as soon as possible. Prepare for this step ahead of time, as well.

STEP 4. Prepare for Inspection of Products (for manufacturers only)

This specific step is reserved for businesses that will manufacture their product/s. Asides from evaluating all submitted information, the FDA will visit your establishment for inspection.

The inspection is dedicated to ensuring that the location, process, and product itself are devoid of any dangerous elements that might be hazardous to humans.

There will be a pre-opening inspection for all manufacturers. They will also do this spontaneously from time to time once your business is up and running as part of the agency’s post-marketing surveillance activities.

STEP 5. Wait Patiently for the Results

Upon accomplishing the previous steps, the waiting game is afoot.

Thankfully, your anxiety from waiting for the final result is curtailed by your ability to check the status of your application provided in the eServices Portal!

Once your application proves successful, you now have the authorization to sell and/or distribute your product and can move on toward securing a Certificate of Product Registration (CPR). This will be valid for one year and will be upgraded to two years upon renewal.

You can also then request to be listed in the FDA Verification Portal — an online portal that provides a comprehensive list of Establishments and Health Products with License to Operate (LTO) and Certificate of Product Registration/Notification (CPR/CPN).

— — — — —

While there is still much left to be tackled, acquiring a license to operate your product is another ticked box off of a far longer list of steps you have to finish to fully and legally establish your business.

Fear not and conquer ahead by now acquiring a Certificate of Product Registration!

You can also check Digest.ph for more information regarding upfront pricing, scopes of work, and other legal services.