PLE2 Regulations & Classifications

Question 1

Which regulation classifies medicines into GSL/P/POM

Answer 1

Human Medicines Regulations 2012

Question 2

GSL

Answer 2

Premises can be closed to the public
SELF SELECTION
Can be used with reasonable safety

Question 3

P meds

Answer 3

Sold under PHARMACIST SUPERVISION
Require specialist advice
Dispensed from pharmacy

Question 4

POM

Answer 4

Require SUPERVISION for safe use
Prescribed by HCP
Dispensed from pharmacy

Question 5

Which medicinal classes can be sold OTC?

Answer 5

GSL & P

Question 6

Why are medicines reclassified?

Answer 6

To maximise accessibility to effective medicines, whilst minimising risk of harm from inappropriate use

Question 7

Who discuss possible reclassifications?

Answer 7

Stakeholder groups

Question 8

What may reclassification involve?

Answer 8

Introduction of one or more additional legal classes
Classification switches
Removal of a category

Question 9

What must reclassification applications include?

Answer 9

Product information (SPC or PIL)
Clinical overview meets criteria
Risk management plan

Question 10

What is the purpose of a risk management plan?

Answer 10

Outlines risks associated with use, and the action/plan to mitigate these risks

Question 11

Reclassified meds: restrictions relate to….

Answer 11

Max strength
Route of administration
Purpose of use or specified patient group
Pharmaceutical form
Max quantity