FDA e-service portal opened to applicants of food product LTO

Food traders and distributors may now access the Food and Drug Administration’s (FDA) e-service portal, the agency’s online licensing platform, to submit applications for a License to Operate (LTO).

FDA Circular No. 2021-012, issued June 11, 2021, provides the guidelines for the use of the FDA eServices Portal System for LTO application of food traders and food distributors, including wholesalers, importers and exporters of processed food products, food supplements, bottled water and iodized salt.

The portal, previously accessible only to health product establishments, has been updated through this circular to include food traders and distributors applying for an LTO.

This, according to the circular, is part of initiatives to improve regulatory processes and systems, driven by Republic Act No. 11032 or the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018,” which aims to promote digitalization and automation of government transactions.

Under FDA Circular No. 2021-012, food product establishments may submit initial applications, renewals and variations. Types of variations include changes such as transfer of location of offices, change in distributor activity, transfer/addition of warehouse, and change of ownership or business name, among others.

The applicant should file the application online at eservices.fda.gov.ph/. The creation of an account and password is no longer required to access the portal, said the circular.

However, applicants to the FDA’s Center for Food Regulation and Research can’t apply yet for a Certificate of Product Registration through the system, as this option is only available for applicants to the Center for Drug Regulation and Research.

To apply, the authorized officer or qualified personnel of the applicant establishment should read and agree with the “Declaration and Undertaking” in order to continue, as such action binds the applicant to provide accurate information.

“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,” the circular says.

The declared email address is unalterable and should reflect the company email address. If the email address will be changed, a written notification specifying the new email address and the reason for the change should be submitted to FDA.

Further, applications for variation and renewal must be done separately, with the renewal application to be submitted before the applicant applies for changes in information that need to be reflected in the system or registry.

The status of the application may be monitored on the e-service website by validating through the email address used, the circular states.

The submitted application and documentary requirements will go through a pre-assessment for completeness and correctness.

The eServices Portal System will automatically send a notification on the result of the pre-assessment through the registered email address of the applicant.

If the application passes the pre-assessment step, the applicant will receive the order of payment with reference number through email indicating the fees to be paid.

If the application is denied, the eServices will notify the reasons or deficiencies found and prompt the applicant to apply again through the portal using a new case number.

Payments shall be made only after receiving the order of payment, the circular stressed. This can be done through over the counter at FDAC, on-coll payment at Land Bank of the Philippines branches, or online payment through Bancnet.

The LTO is released to the applicant through his or her registered email address and a copy may also be accessed through the FDA eServices Portal.

The establishment should then print the LTO and place it on the most conspicuous place within the business establishments.

In May last year, the FDA announced the launch of the online service portal as the agency continues to simplify and streamline its licensing procedures and requirements. With the portal, it said the LTO could then be printed by the applicant in the comfort of his or her home, without need for mailing or even coming to the FDA just to get the LTO.

At recent stakeholder meetings, recommendations to further improve the e-service system include the following:
• Ensure eServices uploading system is functional
• Pre-assessment should only be a preliminary documentary check
• Rejection of pre-assessed documents should include an outcome report for consistency
• Provide alternative payment gateways and extend validity of the order of payment up to five days
• Have a document tracking feature in the eServices website
• Create an email account dedicated to answering questions and responding to problems regarding eServices
• Consider taking out the documentary requirements such as certificate of training and risk management plan

Businesses, particularly micro, small and medium enterprises (MSMEs), have for a long time made known their struggles with the challenges and delays in getting the FDA’s mandatory LTO and CPR, a situation they said hindered their growth.

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