FDA launches online portal for LTO issuance
The Food and Drug Administration (FDA) has launched an online service portal for the issuance of the License to Operate (LTO) and the planned dry run for the e-registration system for the Certificate of Product Registration (CPR) as the agency continues to simplify and streamline its licensing procedures and requirements. The e-services portal covers LTO applications, renewals, and variations (changes in an office location, product labeling, etc.) of drugstores, retail outlets for non-prescription drugs (RONPDs), drug distributors (exporters/importers/wholesalers), and drug traders. The portal can be accessed at http://eservices.fda.gov.ph/.
The Center for Food will follow within the month, Dr. Oscar G. Gutierrez, Jr., OIC-director of the FDA's Policy and Planning Service, said in a presentation made on May 21 during a webinar organized by the University of the Philippines Public Administration Research and Extension Services Foundation Inc.
For CPR, a dry run kicked off on May 26 for the new e-registration system. Currently, processing of the CPR for food products takes about 114 days, but under the e-registration system, "maximum processing time will be 20 days in compliance with ARTA, Gutierrez said.
In the pipeline, to be implemented within the year are e-registration for drugs; revisions for the e-notification for medical devices to make sure FDA complies with the ASEAN medical device directives and e-LTO for manufacturers.
Importers of COVID-19 goods should use one-stop-shop for fast LTO issuance-FDA
In the same forum, Gutierrez encouraged importers to avail themselves of the Bayanihan One Stop Shop (BOSS) facility to fast-track the importation of critical COVID-19 commodities intended for commercial distribution.
The BOSS was created under Joint Memorandum Circular (JMC) 01-2020 issued on April 2 by the FDA, the Bureau of Customs (BOC), and the Anti-Red Tape Authority (ARTA).
Critical COVID-19 health products include sanitizers/hygiene products (alcohol); personal protection equipment; diagnostic products like the PCR and Antibody/Rapid Test Kit; case management products such as medicines, medical devices, respirators and ventilators; and food products like processed foods, food supplements, and raw materials.
Under normal conditions, importations of COVID-19 critical commodities regulated by the FDA will require the issuance of the relevant LTO to the importer and registration or notification of every health product unless explicitly exempted. The importer will then be required to present this LTO and/or the CPR/Notification to the BOC for the latter to clear the commodities for entry into the country.
Through this application facility for LTO, the FDA will be performing a three-step procedure-from submission and evaluation to payment online, with processing to be completed within the day, or even a matter of hours while printing of the LTO will be done by the applicants at the convenience of their homes and offices. In addition, the BOC can already view what is happening at the FDA so the bureau can start processing the release of the products. The FDA BOSS application portal may be accessed at http://boss.fda.gov.ph. --- Philexport News and Features