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Importing Pharmaceutical Products: What Every Importer of Drugs and APIs Should Know

  • Training

  • 90 Minutes
  • Compliance Online
  • ID: 5975207
This training program will focus on U.S. import entry compliance and FDA import entry compliance. U.S. import requirements for pharmaceutical products are among the most rigorous of any country. As a result, it is critical for importers of drugs and APIs to know and comply with these requirements. Failure to comply with U.S. import requirements may result in clearance delays or import shipments being refused entry into the U.S.

Why Should You Attend:

This webinar will focus on U.S. import requirements for drugs and APIs. Attendees will learn about the entry process and the various regulatory agencies that share jurisdiction over the import of drugs and APIs. On completing this course, attendees will be familiar with HTS classification for these pharmaceutical products, customs bonds and documentation requirements, in addition to gaining an understanding of FDA import requirements such as proper use of FDA product codes and affirmation of compliance codes. The requirements for importing investigational and research products will also be highlighted.

Learning Objectives:

After completing the webinar, attendees will be able to:
  • Know how the U.S. entry process for pharmaceutical products works
  • Know FDA import requirements for pharmaceutical products
  • Learn strategies to avoid unnecessary clearance delays

Areas Covered in the Webinar:

  • Import entry compliance
  • Import documentation
  • Custom bond requirements
  • HTS classification for drugs and API
  • Special duty rates and programs for pharmaceutical products
  • FDA product codes
  • FDA Affirmation of Compliance codes
  • Importing investigational and research products (both clinical and non-clinical)
  • Participating Government Agency (PGA) requirements

Who Will Benefit:

  • Employees from companies engaged in international trade of pharmaceutical products
  • U.S. importers of pharmaceutical products
  • Pharmaceutical sponsors and investigators importing clinical drugs into the U.S
  • Purchasing department staff of health industry
  • Compliance officers
  • Logistics/supply chain managers and analysts
  • Trade regulatory/legislative affairs professionals
  • Sales/marketing personnel
  • Training personnel
  • Consultants
  • International business operations

Course Provider

  • Reynaldo Roman
  • Reynaldo Roman,