International Vendor Shipping Procedures - Amgen

More documents

Recommendations

Info

Amgen’s Import/Export office (contacts above) will validate documents, direct brokers on specific clearance instructions and communicate with Shipper if additional / clarification of information is required. * Please send concurrent copies of shipping documentation to each Amgen Contact (as listed above)* Documentation: Shipping documentation must include as appropriate: • Airway Bill • Customs Invoice, including HTSUS and other detailed information (see below) • TSCA Certification (see below for guidance on chemical shipments) • USDA Statement (see below for guidance on chemically synthesized materials, animal/plant/human derived material shipments or shipments of animals/plants) • Other Documentation as required per commodity (see below) Customs Invoice: Per the U.S. Code of Federal Regulations, 19 CFR 141.86 at http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=201019, the invoice MUST contain the following information, which is supplied by the Vendor. 1. Shipper and Consignee name and address (Shipper must provide complete contact information for AT LEAST two individuals, including names, phone numbers and email addresses). 2. Detailed commodity description, quantity/weights, cost/value, HTSUS Code (Harmonized Tariff Schedule United States), and CAS number (if available) of each item. The complete HTSUS, as published by the United States International Trade Commission, can be found at http://www.usitc.gov/tata/hts/bychapter/index.htm. 3. Total cost/value of shipment with currency of sale indicated Please note: Per the U.S. Code of Federal Regulations, 19 CFR 152 at http://www.access.gpo.gov/nara/cfr/waisidx_09/19cfr152_09.html , U.S. Customs requires an accurate value be placed on imported goods for duties to be assessed. The transaction value serves as the primary basis of appraisement. Transaction value is the price actually paid or payable by the buyer to the seller for the goods imported. Other factors may also add to the dutiable value of merchandise, such as packing costs, selling commissions, royalty or licensing fees, etc. If the transactional value cannot be determined or the goods are being sent free of charge, then an accurate and defendable value must be assigned to the goods by the seller. This can be supplied on a separate commercial invoice for Customs purposes only, or as a separate statement on the original invoice. The value of the goods can never reflect a $0 dollar amount. 4. Break down of itemized charges: Freight: Rebates: Discounts: Insurance: Drawbacks: Packing: Commission: Assists: NOTE: Amgen will be responsible for the payment of the clearance directly to our broker; these costs should be excluded from the cost of the merchandise. 5. Country of origin of the merchandise (not the origin of shipment) http://www.access.gpo.gov/nara/cfr/waisidx_10/19cfr134_10.html 6. Packing details (includes hazmat information and temperature requirements) 7. Terms of sale / delivery terms– Incoterms 8. Purchase Order, Agreement or Contract number MUST be provided. Page 2 of 5 Active Rev 2.0 by DBecker 05/2011
Shipments accompanied by incomplete documentation or documentation that contains inaccurate information, such as the incorrect HTSUS number, or dollar value may be rejected by Amgen and, at Amgen’s option , returned at the shippers sole expense. Importer Security Filing: The Security Filing, also known as the “10+2” initiative, is a U.S. Customs and Border Protection (CBP) regulation that requires importers and carriers to provide additional trade data to CBP for non-bulk cargo shipments arriving into the United States Customs territory (including Puerto Rico) by vessel no later than 24 hours prior to loading. Unitrans, as Amgen’s authorized freight forwarder, collects necessary data via their agents overseas. Shippers must provide Unitrans or its agents with the requested information in the timeframe and manner specified by Unitrans. When a freight forwarder other than Unitrans is utilized, the required information must be furnished to Unitrans and Amgen Import/Export at least 48 hours prior to loading. It is critical that requested data is supplied in a timely manner, because CBP may issue “Do Not Load” messages to carriers and penalties to the importers for non-compliance. Any penalties incurred by Amgen caused by Shipper non-compliance with this program will be passed back to the Shipper. The following information must be supplied to Unitrans or promptly upon request and in no event less than 24 hours prior to loading, except in the case of shipments for which a freight forwarder other than Unitrans is utilized, in which case the following information must be supplied to Unitrans and Amgen Import/Export at least 48 hours prior to loading, regardless of whether specifically requested: the names and addresses of the seller, buyer, ship to party, and manufacturer/supplier; container stuffing location; country of origin; 6-digit HTS commodity code(s); importer of record number/foreign trade zone applicant identification number; consignee number(s); consolidator (stuffer); and AMS Bill of Lading number. For more information please visit http://cbp.gov/xp/cgov/trade/cargo_security/carriers/security_filing/ Chemical Shipments: All Chemical shipments require a certification for the Environmental Protection Agency (EPA: http://www.epa.gov/) stating they comply with the regulations of the Toxic Substance Control Act (TSCA) or they are exempt from the TSCA requirements. Shipments will not be released without this certification. The vendor can make this certification on the Customs Invoice or provide a separate statement. Chemically Synthesized Materials, Animal/Plant/Human Derived Material Shipments or Shipments of Animals/Plants: Commodities of these types may require either an import permit or USDA statement, depending on the commodity. Please note the following link to the USDA Guidelines for Importation at, http://www.aphis.usda.gov/import_export/animals/animal_import/animal_imports_nopermit.shtml. Please contact the import/export office in advance to determine if a permit is required (most permits take a minimum of 8 to 12 weeks to receive). If the commodity does not require a permit, an original, signed USDA statement must be provided for clearance through U.S. Customs. Wording requirements and instructions for these statements is provided in the USDA link above. Copy, fax, electronic, email, or stamped signature statements will not be accepted. Shipments will not be released without this certification. Other Documentation Medical Devices: Syringes, needles, thermometers, etc…, may require the manufacturer to provide the Device 510k number, Device listing number, and Device Registration number in order to facilitate FDA clearance. Shippers must also be e-registered with the FDA. Shipments from Shippers who have not completed this electronic registration will be refused entry into the U.S. by the FDA. Chemical/pharmaceutical: Shipments may be subject to Drug Enforcement Administration (DEA) regulations and may require an import permit for clearance into the United States. Shippers must review commodities and apply for any necessary permits. Please utilize the following link http://www.deadiversion.usdoj.gov/imp_exp/index.html or contact Amgen’s Import/Export office with any questions. Sample Shipments: Per the FDA requirements, shipments of pharmaceutical products, which are commercially labeled and approved for use in non US regions/countries must be specifically marked with an additional label as “Samples for Testing”. This label may be placed on the drug product or on the drug product’s outer packaging, and must also be documented on the shipping documentation. Page 3 of 5 Active Rev 2.0 by DBecker 05/2011
Page 1: International Shipping Procedures f
Page 5: enhancements. Shippers who have not

International Vendor Shipping Procedures - Amgen

Create successful ePaper yourself

Delete template?

Save as template?