Medicines Legislation Flashcards
1
Q
State the 2 types of law.
A
- Statute law - made by the state - criminal, professional and administrative.
- Civil law - between citizens
2
Q
Who does the medicines Act 1968 apply to?
A
Retail pharmacies
3
Q
Describe what the HMR 2012 applies to.
A
- Covers all medicinal products for human use during development, production, licensing and supply to the public.
- Monitored and enforced by the MHRA and some aspects by the GPhC.
4
Q
What group of medicines does the HMR 2012 not apply to?
A
Vet medicines
5
Q
Define medicinal product.
A
A substance or combination of substances that has properties to prevent/treat disease in humans.
6
Q
Define medical devices and give examples.
A
Not a medicinal product but used medicinally
Examples: spacer, pacemaker
7
Q
What must be displayed on the packaging of medical device to show it meets a safety and performance requirements?
A
CE - EU symbol
UKCA - UKA conformity assessment
8
Q
Describe the role of the MHRA.
A
- Responsible for ensuring medicines and medical devices work properly and safely.
- Regulates licensing and clinical trials.
- Investigates adverse effects.
- Promotes good practice.
