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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
NATIONAL IMPORT AND EXPORT
REGULATION
• Topics for Discussion in Chapter
• Import Regulation
•
•
•
•

Assessment of Duties
Marking
Standards
Exceptions

• Export Regulation
• General License
• Validated License
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.
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
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
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.
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.
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.
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.
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.
EXPORT REGULATION
• Agency
– Bureau of Export Administration publishes
export restriction.
• Restrictions
– Technical Information
– Goods
– Destination

• License Requirements
– Validate License
– General License
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
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
Regulation regarding Import export of Medicine
Regulation regarding Import export of Medicine
Regulation regarding Import export of Medicine
Regulation regarding Import export of Medicine

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Regulation regarding Import export of Medicine

  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. EXPORT REGULATION • Agency – Bureau of Export Administration publishes export restriction. • Restrictions – Technical Information – Goods – Destination • License Requirements – Validate License – General License
  • 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. 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