1_Laws on Regulation of Health Products

Question 1

What is the purpose of Sales of Drugs Act?

Answer 1

• Narrow scope
• deals w situations where there is transaction in which a “drug” product or prep is sold
• focus on concern that consumer may be defrauded by what he receives from seller

Question 2

Purpose of Poisons Act?

Answer 2

• wider in scope than Sales of Drugs Act
• sale, supply + importation and dealings
• applies to finished products and prep and raw materials and ingredients
• focus on person (storing, transporting) handling “poison”

Question 3

Purpose of Med (Ad and Sale) Act?

Answer 3

• Narrow

- control on element od advertising itself, regardless of whether there is actual sale

Question 4

Purpose of Medicines Act?

Answer 4

• More comprehensive
  clear controls on key activities incl manufacturing, importation, supply and distribution
• introduces new element of product control

Question 5

Purpose of Health Products Act?

Answer 5

• Western-type pharmaceutical medicines
• medical devices
• need for ability to regulate emerging new types of products (CTGT)
• need for ability to regulate new forms of older types of products (‘high-tech’ herbal med)

Question 6

Who is part of Health Products Law?

Answer 6

• Minister of Health in-charge
• adm and enforced by HSA
• subsidary legislation under health products laws made by minister/ HSA w approval of Minister