Bureau of Customs (BOC) refers to the national agency under the Department of Finance in charge of imports, exports, and foreign trade.ĭ. It may refer to a Master Bill of Lading or a House Bill of Lading. The holder or consignee of the bill has the right to claim delivery of the goods at the port of destination. It is a contract of carriage between the carrier and the shipper which defines the liabilities of each party. ![]() Bill of Lading (B/L) refers to a transport document issued by shipping lines, carriers, and international freight forwarders or non-vessel operating common carriers for water-borne freight. In addition, it contains transport instructions to airlines and carriers, a description of the goods, and applicable transportation changes. It is a contract of carriage that includes carrier conditions, such as limits of liability and claims procedures. Air Way Bill (AWB) refers to a transport document for airfreight, used by airlines and international freight forwarders, which specifies the holder or consignee of the bill who has the right to claim delivery of goods when they arrive at the port of destination. ![]() This Circular shall not cover drug products and raw materials used in clinical trials/product development/research, drug products for personal use, donations, and under Compassionate Special Permit, and shall be processed based on existing rules and regulations.Ī. This Circular shall apply to all FDA-licensed drug establishments involved in the manufacture, importation and exportation of finished drug products and raw materials intended for distribution. Conduct inspection of entry/exit ports authorized by the Bureau of Customs (BOC) for finished drug products and raw materials. Provide detailed guidelines and clear procedures in the issuance of Clearance for Customs Release (CFCR) for finished drug products and raw materials.ī. This Circular aims to achieve the following:Ī. Issuance of this guidelines is imperative to ensure the consistency and effectiveness of these regulatory activities. In the interest of public health, import/export activities related to drug products need to be controlled and under the proper oversight of the FDA. 9711, issuance of appropriate authorization such as import/export clearance is necessary to strengthen the FDA’s overall market surveillance and control regulatory function. Therefore, as part of the FDA’s powers and functions under RA No. The infiltration of substandard and falsified drug products into the supply system shall be prevented through risk-based surveillance scheme and rigorous control. However, there is a need to strengthen market control within the distribution chain through additional measures to ensure that the public only receive quality-assured drug products. 2013-032 wherein a valid License to Operate (LTO) and Certificate of Product Registration (CPR) are required for the release of drug products. The FDA hereby issued FDA Memorandum Circular (FMC) No. 9711, states that “ The FDA in coordination with the Bureau of Customs, Bureau of Quarantine and other concerned agencies is mandated to undertake and adopt measures relating to importation of health products such as, but not limited to, sampling and examination, in accordance with relevant existing laws and regulations, of every incoming shipment of health products”. ![]() ![]() 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009”, mandates the FDA to regulate and subsequently issue appropriate authorizations to establishments engaged in the manufacture, distribution, importation, exportation and retailing of health products, among others.Īrticle I Section 6 (Requirements for Every Incoming Shipment of Health Products) of the Book II of the Implementing Rules and Regulation (IRR) of RA No. The deadline for submission of comments is on 23 June 2023.
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