Week 12 / GSL Medicines

Question 1

Q: What is the basic principle under Chapter 2 of the Human Medicines Regulations 2012 regarding the sale or supply of medicinal products?

Answer 1

A:
Under Regulation 220, medicinal products may be sold or supplied (in circumstances corresponding to retail sale) only from registered pharmacies,
unless they are classified as general sale medicines (GSL).

Question 2

Flashcard 1
Q: What are the three legal classes of medicinal products in the UK?

Answer 2

A:

General Sale Medicines (GSL)

Pharmacy Medicines (P)

Prescription-Only Medicines (POM)

Question 3

Q: What does the term ‘PO’ mean in relation to medicines?

Answer 3

A:
‘PO’ stands for ‘Pharmacy Only’ — these are legally GSL medicines, but the manufacturer restricts their sale to pharmacies.
Note: ‘PO’ is not a legal classification.

Question 4

Q: What does the term “over the counter (OTC)” medicine refer to?

Answer 4

A:
OTC refers to medicines available without a prescription, including both GSL and P medicines.

Question 5

Q: Can controlled drugs be GSL, P, or POM?

Answer 5

A:
Yes, controlled drugs can fall under any of the legal classifications (GSL, P, or POM), depending on the drug.

Question 6

Q: Who is responsible for reclassifying medicines in the UK?

Answer 6

A: The MHRA (Medicines and Healthcare products Regulatory Agency).

Question 7

Q: What is the usual direction of medicine reclassification?

Answer 7

A: From POM → P → GSL.

Question 8

Q: What restrictions may apply when a medicine is reclassified? [4]

Answer 8

A:

Indication

Pack size

Strength

Route of administration

Question 9

Q: What are the benefits of switching a medicine class? [4]

Answer 9

A:

Wider patient access

Better use of pharmacists’ expertise

Supports self-care agenda

Reduces NHS costs

Question 10

Q: Name recent medicines that were switched from POM to P. [4]

Answer 10

A:
Fexofenadine

Desogestrel

Topical vaginal oestrogen

Tadalafil

Question 11

Q: Is the pharmacy profession supportive of switches from P to GSL?

Flashcard 7
Q: Can medicines be reclassified from GSL to POM?

Answer 11

A: No, they are generally not keen on P to GSL switches.

A: Yes, but rarely – medicines can move GSL → P → POM if needed.

Question 12

Q: What does GSL stand for?

Answer 12

A: General Sales List.

Question 13

Q: What defines a GSL medicine under the Human Medicines Regulations 2012?

Answer 13

A: A product that is not a POM or P medicine and is covered by a marketing authorisation stating it can be sold on general sale.

Question 14

Q: Where can GSL medicines be sold?

Answer 14

A: At places other than pharmacy premises and without the supervision of a pharmacist.

Question 15

Q: What safety condition must GSL medicines meet?

Answer 15

A: They must be reasonably safe for use without pharmacist supervision.

Question 15

Q: How can you check if a medicine is GSL?

Answer 15

A: By checking its marketing authorisation or consulting a reliable medicines database.

Question 16

Q: Can the classification of a medicine as GSL depend on pack size or strength?

Answer 16

A: Yes, some medicines are GSL only when in a smaller pack size, lower strength, or for a specific indication/form.

Question 17

Q: Where can GSL medicines be sold?

Answer 17

A: At a registered pharmacy or any premises that can be closed to exclude the public.

Question 18

Q: What packaging requirement applies to GSL medicines sold outside pharmacies?

Answer 18

A: The product must be made up for sale elsewhere and not opened since then.

Question 19

Q: What is Schedule 15 in relation to GSL medicines?

Answer 19

A: Medicines listed in Schedule 15 must be sold according to the specific requirements in that schedule.

Question 20

Q: Can GSL medicines be sold from vending machines?

Answer 20

A: Yes, if the machine is in a location that can be closed to exclude the public.

Question 21

Q: What must be in place when GSL medicines are sold from a pharmacy?

Answer 21

A: A responsible pharmacist must have signed in and assumed their role.

Question 22

Q: What is the exception to retail sale restrictions for GSL medicines?

Answer 22

A: Supply in the event or anticipation of a pandemic disease.

Question 23

Q: Can GSL medicines be sold on aircraft and trains?

Answer 23

A: Yes, by the operator or commander of the aircraft or train.

Question 24

Q: What are the storage conditions for GSL sales on aircraft/trains?

Answer 24

A: Medicines must be pre-packed elsewhere and stored in a section closed to the public.

Question 25

Flashcard 1 Q: Are products containing high doses of vitamins always GSL? Flashcard 2 Q: Are eye ointments classified as GSL medicines? Flashcard 3 Q: Are anthelmintics considered GSL products? Flashcard 4 Q: Can medicines for parenteral administration be sold as GSL? Flashcard 5 Q: Are enemas GSL medicines? Flashcard 6 Q: Are products mainly used for irrigation (e.g., wounds, bladder) GSL? Flashcard 7 Q: Can aspirin or aloxiprin for children be sold as GSL?

Answer 25

A: No — products with more than the specified maximum daily dose of vitamin A or D are not GSL. A: No, eye ointments are not GSL. A: Not usually — unless the marketing authorisation classifies them as GSL. A: No, unless authorised otherwise. A: No, unless specifically classified as GSL by the marketing authorisation. A: No, unless authorised as GSL. A: Only if the marketing authorisation classifies them as GSL.

Question 26

1) GSL medicines may be sold from a supermarket which does not have a pharmacy on the premises ✅ True As long as the premises can be closed to exclude the public and the medicines meet GSL criteria, this is allowed. 2) GSL medicines can be sold from an automatic vending machine located in a pub ❌ False Vending machines must be located in premises that can be closed to exclude the public. A pub does not meet this requirement. 3) GSL medicines can be sold from a stall at an open-air pop festival ❌ False An open-air stall cannot be closed off from the public, so it doesn't meet the condition for GSL sales. 4) Water for injection is classified as a GSL medicine, because water is not a medicinal product ❌ False Water for injection is a medicine used parenterally, which is not GSL unless specifically authorised as such. 5) A medicine for treating threadworms will never be classified as GSL ❌ False Some anthelmintics (e.g., for threadworms) may be classified as GSL if the marketing authorisation allows it. 6) GSL medicines may be sold from a car boot in a car boot sale ❌ False This setting typically cannot be secured to exclude the public, so not appropriate for GSL medicine sales. 7) GSL medicines may be sold from a mobile pharmacy van that attends public entertainment events ✅ True Yes, as long as the van can be closed to exclude the public and all other GSL conditions are met. 8) The definition of a GSL medicine is a medicine that can be sold safely from non-pharmacy premises ✅ True That’s the general idea — safety from non-pharmacy premises without pharmacist supervision. 9) It is rare for medicines to move from GSL to P to POM ✅ True The usual direction is POM → P → GSL. Movement in the reverse direction is rare. 10) GSL medicines can be sold like any other commodity because they are safe ❌ False While relatively safe, GSL medicines are still regulated, and sales must meet legal conditions.

Answer 26

1) GSL medicines may be sold from a supermarket which does not have a pharmacy on the premises ✅ True As long as the premises can be closed to exclude the public and the medicines meet GSL criteria, this is allowed. 2) GSL medicines can be sold from an automatic vending machine located in a pub ❌ False Vending machines must be located in premises that can be closed to exclude the public. A pub does not meet this requirement. 3) GSL medicines can be sold from a stall at an open-air pop festival ❌ False An open-air stall cannot be closed off from the public, so it doesn't meet the condition for GSL sales. 4) Water for injection is classified as a GSL medicine, because water is not a medicinal product ❌ False Water for injection is a medicine used parenterally, which is not GSL unless specifically authorised as such. 5) A medicine for treating threadworms will never be classified as GSL ❌ False Some anthelmintics (e.g., for threadworms) may be classified as GSL if the marketing authorisation allows it. 6) GSL medicines may be sold from a car boot in a car boot sale ❌ False This setting typically cannot be secured to exclude the public, so not appropriate for GSL medicine sales. 7) GSL medicines may be sold from a mobile pharmacy van that attends public entertainment events ✅ True Yes, as long as the van can be closed to exclude the public and all other GSL conditions are met. 8) The definition of a GSL medicine is a medicine that can be sold safely from non-pharmacy premises ✅ True That’s the general idea — safety from non-pharmacy premises without pharmacist supervision. 9) It is rare for medicines to move from GSL to P to POM ✅ True The usual direction is POM → P → GSL. Movement in the reverse direction is rare. 10) GSL medicines can be sold like any other commodity because they are safe ❌ False While relatively safe, GSL medicines are still regulated, and sales must meet legal conditions.