Regulation regarding Import export of Medicine


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Regulation regarding Import export of Medicine

  1. 1. Scholar Dr.Bidhan Mahajon Guide Dr. Remadevi.R. MD(AYU) Professor and H.O.D 1 Department of Dravyaguna Vijnanam V.P.S.V. Ayurveda College Kottakkal
  2. 2. NATIONAL IMPORT AND EXPORT REGULATION • Topics for Discussion in Chapter • Import Regulation • • • • Assessment of Duties Marking Standards Exceptions • Export Regulation • General License • Validated License
  3. 3. IMPORT REGULATION • Assessment of Duties-tax on imported good. – Classification of Goods • Source – Harmonized Tariff Schedule-uniform classification system used to classify goods for assessment of duties on imported goods. » Sections-22 sections that broadly cover products from different industries. » Chapter-99 chapters that groups products by industry ranging from agricultural and components to finished products. Headings and subheading follow chapter.
  4. 4. IMPORT REGULATIONS • Assessment of Duties – Classification of Goods • Interpretation-when a good can be classified in more than one tariff selection, must resort to General Rules of Interpretation. – Rule of Specificity-requires use of Heading that provides the more specific description of the good over one that gives a general description – Essential Character-Heading for material, component, or function that provides for essential character of good – Deference is given to Customs Interpretation
  5. 5. IMPORT REGULATIONS • Assessment of Duties – Tariff Computation • Forms of Tariff » Ad Volorem Duties-percentage rate on imported good. » Specific Duty-specified amount on imported goods. » Compound Duty-both ad valorem and specific duty. • Tariff Computation » Duty=Value of Good X Tariff Rate
  6. 6. IMPORT REQUIREMENTS • Assessment of Duties – Valuation of Goods is based on Transaction Value of Good • Transaction Value requires that the value of the imported good be on a commercially realistic basis. – Price of Identical Goods Sold to Unrelated customer. – Deductive Value-Price of good sold in the United States deducting international freight, duties and commissions. – Computed Value-fabricated by adding the manufacturer’s actual labor and material costs, along with estimates of its general expenses.
  7. 7. IMPORT REQUIREMENTS • Assessment of Duties – Valuation of Goods • Exemptions to Value of the Goods – Section 9802-articles assembled abroad in whole or in part of fabricated components that are products of United States. Maquiladora – Drawbacks-form of tax relief in which a lawfully collected customs duty is refunded or remitted wholly or in part because of the particular use made of the commodity. – Foreign Trade Zones-Zones outside custom territory where activities take place and no duty until departure.
  8. 8. IMPORT REGULATION • Assessment of Duties – Country of Origin-determining the nationality of a product. • Approaches to determining Country of Origin – Substantial Transformation-last country in which product changed into different product. – Value Added-based on percentage of component parts making up finished good. Problem with this approach. – Specific process Test-list the types of processes or operations that are considered to confer origin of good – Change in Tariff Classification-product changes tariff.
  9. 9. IMPORT REQUIREMENTS • MARKING REQUIREMENTS – In United States, imported goods must be marked as to country of origin • Whether or nor marking is required is determined if the purchaser is the ultimate purchaser. – Customs Modernization Act • Importer is under a duty of reasonable care to correctly classify and value the goods being imported and keep proper records on imported good.
  10. 10. IMPORT REGULATION • STANDARDS REQUIREMENT-use of product quality, safety measures, quantity measure to impede imports. – Agreements • WTO Agreement of Technical Barriers to Trade • WTO Agreement on Sanitary Phyto-Sanitary • International Labor Organization – Purpose • Requires that member nation not use standards to impede imports and makes rules transparent.
  11. 11. EXPORT REGULATION • Agency – Bureau of Export Administration publishes export restriction. • Restrictions – Technical Information – Goods – Destination • License Requirements – Validate License – General License
  12. 12. EXPORT REGULATION • License Requirements – General License-not required for individual exporters • Shipper’s Export Declaration • Destination Control Statement – Validated License-grants a specific license for specific exporter for specific destination – Is Country on Country List? – Is Product on Commodity Control List
  13. 13. EXPORT REGULATIONS • Government Agencies Relevant to Exporting – Department of Energy-nuclear technology and Gas – Department of Justice-Drugs – Munitions- Department of State – Environmental Protection Agency-Pesticides – Patent and Trademark-Intellectual Property