Foreign donations of Personal Protective Equipment (PPE), including masks, shoe covers, gloves, head covers and gowns are exempted from securing clearance from Food and Drug Administration (FDA).
The Bureau of Customs (BOC) issued the clarification on Monday, citing that FDA had coordinated with BOC on the exemption of these foreign donations from securing FDA clearance.
Moreover, BOC said, FDA mentioned that companies other than medical device establishments, who use face masks in the performance of their jobs and are strictly for company use are allowed to directly import these donated items without any certification from the FDA.
As a general rule, securing marketing authorization from FDA, either in the form of a certificate of product notification (CPN), or certificate of product registration (CPR), is required from all importers of all products depending on the health risk of these products prior to Customs release.
“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,” BOC said in a news statement on Monday.
“The FDA and BOC assures that both agencies are prioritizing the expeditious facilitation of PPEs for donation and commercial purposes,” it said.
In a related development, the Department of Finance (DOF), BOC and other national government agencies have also signed the Joint Administrative Order (JAO) No. 01-2020 on the clearance of relief consignments entered during a state of calamity.
According to the JAO signed March 16, which took effect starting March 21, donated or leased relief consignment, including equipment, entered shall be exempted from payment of duties and taxes.
However, the donations must satisfy specific conditions in order to be tax-exempt.
Food, medicines, medical supplies, clothing and other in-kind donations must be donated only to a qualified-donee (government institution, or private entity accredited by respective government agency), must be imported only during a state of calamity, and must be for free distribution or use of the affected population.
On the other hand, equipment and materials for shelter must be intended for specific calamity-affected area during operations and be leased only to government institutions or accredited private entities.
The Philippine International Humanitarian Assistance Reception Center – One-Stop-Shop (PIHARC-OSS) facility shall be adopted as the facilitation center for relief consignment including the issuance of documents and entitlement of entry as relief consignments and their expedited release from customs custody.
As for the processing at the One-Stop-Shop (OSS), the donor, done, or its duly authorized representatives, shall inform the PIHARC-OSS, through the Department of Foreign Affairs, of the incoming donation prior to arrival of the shipment.
Upon receipt of the documentary requirements, the OSS shall issue the relief consignment supplemental form, which serves as proof of entitlement to tax and duty exemptions and clearance, if necessary, for release.
The BOC shall then process the release of relief consignment under a simplified clearance procedure.
The facilitated relief consignments shall not be allowed entry for consumption into the domestic territory unless the proper duties, taxes and other charges have been paid.
Equipment which are not re-exported within the prescribed period, or for which no payment of the proper duties, taxes and other charges has been made, shall be proceeded against in accordance with existing provisions of the Customs Modernization and Tariff Act.
Unless the PIHARC-OSS is activated by the National Disaster Risk Reduction and Management Council, processing of relief consignments entered during a local state of calamity as declared by the local sanggunian shall follow the regular procedures in the processing of donations, including application for the requisite permits and licenses from the concerned regulatory agencies and the tax exemption indorsement from the DOF.