Medicines Regulation

Question 1

Human Medicines Regulations 2012, Reg 2(1)

Answer 1

Is it a medicinal product?

Question 2

Human Medicines Regulations 2012, Reg 46

Answer 2

Unlawful to supply a medicinal product without a marketing authorisation

Question 3

Human Medicines Regulations 2012, Reg 58(4)

Answer 3

Marketing authorisation requirements:
(a) Efficacy
(b) Safety
(c) Quality

Question 4

Human Medicines Regulations 2012, Reg 62(1)

Answer 4

Marketing authorisation must specify whether the medicinal product is:
- Prescription only
- Supplied by a pharmacist without a prescription
- General sale list medicine

Question 5

Traditional Herbal Medicine Registration (THR)

Answer 5

Alternative for herbal medicines
- Can claim to treat a minor self-limiting condition

Question 6

THR Requirements

Answer 6

1. Evidence of safety
2. Evidence of quality
3. Evidence of traditional use for a given purpose for at least 30 years (at least 15 in the EU)

Does NOT require:
- Evidence of efficacy (RCT)

Question 7

Simplified Scheme

Answer 7

Alternative 1 for homeopathic medicines
- Cannot claim to treat anything

Question 8

Simplified Scheme Requirements

Answer 8

1. Evidence of quality
2. Evidence of sufficient dilution to show safety

Does NOT require
-Evidence of efficacy (RCT)

Question 9

National Rules Scheme (NRS)

Answer 9

Alternative 2 for homeopathic medicines
- Can claim to treat a minor self-limiting condition

Question 10

NRS Requirements

Answer 10

1. Evidence of quality
2. Evidence of sufficient dilution to show safety
3. Evidence of historical use within the homeopathic tradition for a given purpose