THE Bureau of Customs (BoC) said imported donations of personal protective equipment (PPE) will be exempt from Food and Drug Administration (FDA) clearance requirements to expedite their release to frontline personnel working to contain COVID-19 (coronavirus disease 2019).
In a statement Monday, the bureau said the exempt supplies include N95 face masks, shoe covers, gloves, head covers and gowns.
The BoC said that prior to customs release, importers of all goods, as a rule, are required to secure marketing authorization from the FDA via a Certificate of Product Notification (CPN) or Certificate of Product Registration (CPR) depending on the associated health risks.
However, the bureau said “foreign donations of PPEs are exempted from securing an FDA clearance” considering that these items are urgently needed.
“As to PPEs intended to enter the local market for commercial purposes, the FDA clarified that importers of PPEs for commercial purposes are exempt from presentation of a CPN/CPR prior customs release provided that they are able to provide a copy of License to Operate (LTO) and proof of application for product notification with the FDA,” it added.
According to BoC data, a total of 459 shipments of PPE and medical supplies were released as of Saturday by the bureau, which is implementing a minimal-staffing scheme.
Separately, the bureau said it is now accepting “provisional goods declarations” (PGDs) or an incomplete declaration of goods that will allow tentative release of shipments with pending documents to be provided within a scheduled date.
This is authorized by Customs Memorandum Order No. 07-2020 dated March 6 issued by Commissioner Rey Leonardo B. Guerrero.
“It shall be allowed on cases when there are no necessary permits/clearances from regulatory agencies have been presented at the time of lodgement. This may be allowed as long as the application for such permit were filed to the appropriate regulatory agency pending issuance and that necessary permits/clearances shall still be submitted within the time frame prescribed by the said regulatory agency,” the BoC said in a separate statement.
The bureau said it will also allow PGDs if a tax exemption indorsement has not been issued at the time of lodgement but an application is pending, as well as if the declarant lacks some information or documents to complete the transaction.
The CMO also stipulates that an “accepted PGD” is to be deemed a complete declaration, with regard to duties and taxes. It may be subject to tentative assessment of duties, taxes and other charges, if a tentative release was requested, and is subject to final readjustment once the pending necessary information or documents has been provided. — Beatrice M. Laforga