regulation regarding import export of medicine

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Scholar Scholar Dr.Bidhan Mahajon Dr.Bidhan Mahajon Guide Guide Dr. Remadevi.R. MD(AYU) Dr. Remadevi.R. MD(AYU) Professor and H.O.D Professor and H.O.D Department of Dravyaguna Vijnanam Department of Dravyaguna Vijnanam V.P.S.V. Ayurveda College V.P.S.V. Ayurveda College Kottakkal Kottakkal 1

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Page 1: Regulation regarding Import export of Medicine

ScholarScholar

Dr.Bidhan MahajonDr.Bidhan Mahajon

GuideGuide

Dr. Remadevi.R. MD(AYU) Dr. Remadevi.R. MD(AYU)

Professor and H.O.D Professor and H.O.D

Department of Dravyaguna VijnanamDepartment of Dravyaguna Vijnanam V.P.S.V. Ayurveda CollegeV.P.S.V. Ayurveda College

Kottakkal Kottakkal 1

Page 2: Regulation regarding Import export of Medicine

NATIONAL IMPORT AND EXPORT REGULATION

• Topics for Discussion in Chapter• Import Regulation

• Assessment of Duties

• Marking

• Standards

• Exceptions

• Export Regulation• General License

• Validated License

Page 3: Regulation regarding Import export of Medicine

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.

Page 4: Regulation regarding Import export of Medicine

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

Page 5: Regulation regarding Import export of Medicine

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

Page 6: Regulation regarding Import export of Medicine

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.

Page 7: Regulation regarding Import export of Medicine

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.

Page 8: Regulation regarding Import export of Medicine

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.

Page 9: Regulation regarding Import export of Medicine

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.

Page 10: Regulation regarding Import export of Medicine

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.

Page 11: Regulation regarding Import export of Medicine

EXPORT REGULATION

• Agency– Bureau of Export Administration publishes

export restriction.• Restrictions

– Technical Information– Goods– Destination

• License Requirements– Validate License– General License

Page 12: Regulation regarding Import export of Medicine

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

Page 13: Regulation regarding Import export of Medicine

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

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