Introduction to Medicines Regulation

Question 1

What was the first restrictive legislation?

Answer 1

The Arsenic Act 1851

Question 2

Which law controlled the manufacture of the number of products of which purity and potency could not be tested?

Answer 2

The Therapeutic Substance Act 1925

Question 3

Which laws were introduced after painkillers were used in WW1?

Answer 3

International Opium Convention

Dangerous Drugs Act 1920

Question 4

Which 3 pieces of legislation followed the thalidomide tragedy?

Answer 4

The Medicines Act 1968
The Misuse of Drugs Act 1971
The Poisons Act 1972

Question 5

What replaced The Medicines Act 1968?

Answer 5

The Humans Medicine Regulation 2012 (14th August)

Question 6

What is the The Humans Medicine Regulation 2012?

Answer 6

Single piece of legislation applicable to all medicinal products at development, production, licensing and supply.

Question 7

Who is The Humans Medicine Regulation monitored and enforced by?

Answer 7

Medicines and Healthcare Products Regulatory Agency (MHRA)

Question 8

Who regulates a medical device?

Answer 8

The Medical Devices Regulation 2002

Question 9

How is a medical device indicated?

Answer 9

By CE on the packaging

Question 10

What is the definition of a medicinal product?

Answer 10

any substance/combination of substances shown as having properties of preventing/treating disease in human beings, or which can restore/correct/modify a physiological function by exerting a pharmacological/immunological/metabolic action to make a medical diagnosis.

Question 11

What is the definition of administer?

Answer 11

orally by injection, or by introduction to the body another way
by external application, either in existing state of after it has been dissolved/dispersed/diluted/mixed with another substance used as a vehicle.