Introduction To Medicines Regulation

Question 1

What are the two major classes law can be divided into

Answer 1

• Statute Law
• Civil Law

Question 2

What are the subdivisions of Statute law

Answer 2

• Criminal Law
• Administrative Law
• Professional Law

Question 3

What was the first piece of restrictive Legislation?

Answer 3

The Arsenic Act (1851)

Question 4

When was the penicillin act made?

Answer 4

1947

Question 5

When was the therapeutic substances act introduced

Answer 5

1956

Question 6

What is the Therapeutic Substance act?

Answer 6

It controls the manufacture of small number of products the purity and potency of which could not be tested by chemical means

Question 7

When was the committee on safety of drugs formed

Answer 7

1963

Question 8

What is the 3 key legislations relating to drugs and medicines in the UK

Answer 8

-The Medicines Act 1968
- The misuse of Drugs Act 1971
- The Poisons Act 1972

Question 9

What happened to The Poisons Act (1972)

Answer 9

It was repealed in 2015 and replaced with other legislation to control poisons

Question 10

When did the Human Medicines regulations come into place?

Answer 10

2012

Question 11

What is HMR (2012) applicable to?

Answer 11

Applicable to all medicinal products for human use at every stage of development, production, licensing, and supply to the public

Question 12

Who enforces the HMR act?

Answer 12

The Medicines and Healthcare Products Regulatory Agency (MHRA)
Some aspects relating to pharmacy are monitored by the General Pharmaceutical Council (GPHC)

Question 13

What is the Medicines and Healthcare Products Regulatory Agency (MHRA)

Answer 13

A government agency which is responsible for ensuring that medicines and medical devices work properly and are acceptably safe

Question 14

What does Medicinal Product mean?

Answer 14

• A substance or combination of substances presented as having properties of preventing or treating disease in human beings
  Or
• A substance or combination of substances that may be used by or administered to human beings with a view to;
  — restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action
  Or
  — Making a medical diagnosis

Question 15

What does Administer mean?

Answer 15

Administering something to a human being
- Orally, by injection or by Introduction into the body in any other way;
Or
- By external application, either in its existing, dissolved, dispersed, diluted states or mixed with substances presented used as a vehicle