The Importer - Business Review Webinars

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FDA – Product Code <strong>The</strong> FDA Product Code is a seven characters long and is broken into the following five fields. Industry, Class, Subclass, Process Identification Code (PIC), Product PIC - specifies either the process, storage or dosage form depending on the type of product. A missing or incorrect FDA product code is one of the most common reasons for a hold/rejection! http://www.accessdata.fda.gov/scripts/ora/pcb/tutorial/tutorial.cfm
FDA – ITACS What is ITACS? - Import Trade Auxiliary Communications System ITACS is a newly created internet portal for import trade. It is linked to FDA’s Mission Accomplishment and Regulatory Compliance Services (MARCS) import entry review system. ITACS will allow users to view current FDA status on import entries and allow for faster communication between FDA and entry filers. Some of the benefits of ITACS: · View current FDA status of entries · Submit documents directly to FDA · Documents can be submitted through ITACS instead of local FDA port office · ITACS will be operational even if CBP/FDA interface is down · No waiting time for return phone calls · Detailed information regarding shipment: at the line level Who can access ITACS? Anyone with a valid entry number can access ITACS. What entries can be viewed? Any entry at any port which was successfully transmitted to CBP/FDA via ABI (i.e., broker entry). Link to ITACS: https://itacs.fda.gov/itacs/app/welcomeToITACS.jsf
Page 1 and 2: Navigating the regulatory Maze for
Page 3 and 4: Clinical Supply Chain Interruptions
Page 5 and 6: Help! Customs is holding my shipmen
Page 7 and 8: Roles & Responsibilities - Importer
Page 9 and 10: Roles & responsibilities - Customs
Page 11 and 12: INCO Terms 2010
Page 13 and 14: Invoice Tour • Key data elements
Page 15 and 16: Invoice Tour - ULTIMATE CONSIGNEE U
Page 17 and 18: Invoice Tour - IMPORTER OF RECORD I
Page 19 and 20: Invoice Tour - TSCA TSCA Statement:
Page 21 and 22: Invoice Tour - QTY, PCS,WEIGHT, ETC
Page 23 and 24: Invoice Tour - HTS CODE US HTS# 300
Page 25 and 26: Invoice Tour - FDA IND # FDA IND# 1
Page 27 and 28: Invoice Tour - PACKING DETAIL PACKE
Page 29 and 30: Electronic Transactions CBP shares
Page 31 and 32: HTS - Harmonized Tariff System U.S.
Page 33 and 34: Poll Question 2 Q. Is duty payable
Page 35 and 36: Definitions - Pharmaceutical Produc
Page 37 and 38: API - EU Regulations • The US is
Page 39: FDA - “FLAGS” FD0 - Indicates t
Page 43 and 44: USDA USDA Permit - When required, a
Page 45 and 46: The Regulatory Maze Most countries
Page 47 and 48: Recruitment Value Which Country Off
Page 49 and 50: China Exporting Biological Samples
Page 51 and 52: China Importing Reagents Permit app
Page 53 and 54: Brazil Importing Clinical Materials
Page 55: Q&A For further Discussion or Work-

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