FDA set to impose revised license application fees

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The Food and Drug Administration (FDA) will be implementing its new schedule of application fees and charges once the relevant draft administrative order currently under review is approved, according to an FDA official.

Estrellita Pastolero, division chief for policy dissemination and training at the FDA, said the agency is now reviewing plans to revise not just its fees and charges but also its licensing requirements and procedures.

Speaking at a recent webinar on FDA services, Pastolero said the current schedule of fees and charges is still based on the decades-old Administrative Order (AO) No. 50 series of 2001.

She said that following consultations with industry stakeholders, the agency has drafted a new AO that is under review and awaiting approval by the health secretary.

She added that “most probably baka ma-implement ung bagong fees and charges namin by early part of 2025.”

Also being scrutinized by the Department of Health (DOH) is draft AO No. 2020-0017 on the revised guidelines for the unified licensing requirements and procedures of the FDA. Once approved, the new AO will repeal AO No. 2016-0003.

Pastolera further shared that likewise under study is extending the validity period of the FDA’s license to operate (LTO).

For food establishments, the initial LTO is valid for two years and the renewed LTO is good for five years. The FDA is now proposing to extend the maximum validity period of the LTO to 12 years.

“You will be virtually informed when this happens because we are giving priority to the other administrative orders that we have submitted to the Department of Health,” said Pastolera in mixed English and Filipino.

Meanwhile, she gave important reminders and advice to food stakeholders relating to applying for licenses, certifications and authorizations.

She reminds applicants that “application for renewal shall be done within three months or 90 days prior to the validity date of the LTO. Applications filed after the validity date of the LTO shall be subject to surcharge as prescribed in Republic Act No. 9711 and its implementing rules and regulations.”

In fact, Pastolero added, if late renewal application takes place four months after the validity period has expired, there will not only be a penalty, but the renewal application will be treated as an initial application.

As to where payment for an LTO, a certificate of product registration (CPR), or an authorization may be made, Pastolera advises paying through the LandBank Link.Biz Portal at https://www.lbp-eservices.com/egps/portal/index.jsp.

Applicants may also pay online via BancNet, making sure the biller or institution is FDA Philippines.

Pastolero added that payment over the counter at LandBank has been temporarily stopped.

On where applicants may apply for an LTO, a CPR, or an FDA authorization, the executive said food manufacturers should go to the FDA ePortal System, accessible at https://eportal.fda.gov.ph.

“Accessing the FDA ePortal to file an LTO application requires the use of an authorized user account,” said Pastolera, adding that parties may send an email request to the FDA via fdac@fda.gov.ph.

On the other hand, food traders and distributors are directed to go to the eServices Portal to lodge their applications.

Additionally, applicants should be aware that filing time follows a fixed schedule. Submissions to the ePortal System and eServices System are done Mondays through Fridays from 7 a.m. until 6 p.m.

Finally, Pastolera said that since applicants can’t simply drop by the FDA office for transactions, the agency encourages them to contact the agency via email at info@fda.gov.ph, website at www.fda.gov.ph and its social media accounts at fdagovph.

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