Medicines Act

Question 1

What is the Medicines Act 1968

Answer 1

Act of Parliament to control medicines: Human, veterinary, Manufacture and supply.
Influenced by Thalidomide disaster.

Question 2

What is Human Medicines Regulations 2012?

Answer 2

Consolidated the law of UK concerning medicinal products for human use.
The regulations are responsible for:
* Authorisation of [medicinal] products
* Manufacture, import, distribution, sale and supply
* Labelling and advertising
* Pharmacovigilance
– monitoring of the safety of medicines in clinical use

Question 3

Whats the definition of a medicinal product?

Answer 3

any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or:
* any 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

Does not apply to blood.

Question 4

What is The Misuse of Drugs Act 1971?

Answer 4

Intended to prevent non-medical use of certain drugs
* Controls medicinal drugs (also in the Medicines Act) AND drugs with no
current medical uses.
“Controlled drugs”