legal classification of medicines

Question 1

What defines a ‘medicinal product’ under UK law?

Answer 1

A substance used to treat or prevent disease, restore or modify physiological functions, or make a medical diagnosis, as defined by the Human Medicines Regulations 2012.

Question 2

What are the three main legal classifications of medicines?

Answer 2

Prescription Only Medicines (POM), Pharmacy Medicines (P), and General Sales List Medicines (GSL).

Question 3

What are Prescription Only Medicines (POM)?

Answer 3

Medicines that require a prescription from a qualified healthcare professional and are listed in the Prescription Only Medicines (Human Use) Order 1997.

Question 4

What are Pharmacy Medicines (P)?

Answer 4

Medicines that can be sold only in a registered pharmacy under the supervision of a pharmacist.

Question 5

What are General Sales List (GSL) medicines?

Answer 5

Medicines that can be sold in general retail outlets without pharmacist supervision, considered safe for use without professional oversight.

Question 6

Can pharmacists refuse to sell medicines?

Answer 6

Yes, pharmacists can refuse if the sale is not in the patient’s best interest, based on clinical judgment.

Question 7

Give an example of a medicine that changes classification based on packaging.

Answer 7

Paracetamol: a GSL if ≤500mg tablets in packs ≤16; a P medicine in packs up to 32; and a POM if over that.

Question 8

Who is responsible for licensing medicines in the UK?

Answer 8

The Medicines and Healthcare Products Regulatory Agency (MHRA).