Human Medicines Regulations 2012 Lecture Part 1

Question 1

What has changed since the UK left the EU?

Answer 1

• Laws derived from the EU remain in force after the UK’s withdrawal from the EU
• Since leaving the EU the Medicines and Medical Devices Act 2021 was introduced
• Pharmacies do not have to comply with the Falsified Medicines Directive
• MHRA has control over pharmacovigilance
• Medicines which were approved by the EMA’s centralised route (CAPs) were converted into UK MAs when the UK left the EU

Question 2

What do the Human Medicines Regulations cover?

Answer 2

• The HMR is made up of 17b parts and many schedules
• They regulate the manufacture, distribution and importation of medicines for human use
• The advisory structure is principally the Commission on Human Medicines
• It defines what a ‘medicinal product’ is
• Describes the UK’s obligation in relation to pharmacovigilance
• Enforcement of the Regulations is the responsibility of:
• MHRA
• GPHC
• Local drug authorities

Question 3

What is a medicinal product?

Answer 3

any substance or combination of substances presented as having properties of preventing or treating disease in human beings

Question 4

What happened with R v Chapman (Sonny) [2017]

Answer 4

• 4 defendants were found in possession of canisters containing nitrous oxide
• convicted under the Psychoactive Substances Act 2016
• They argued at their appeal that nitrous oxide did not come under the Act as it was classed as a medicinal product
• The nitrous oxide in this case was found not to be a medicinal product

Question 5

Can a substance for a medicinal product for only one purpose?

Answer 5

yes only one purpose but not for another

Question 6

What does MA stand for?

Answer 6

Marketing authorisation

Question 7

What does Homeopathic remedies need?

Answer 7

registration certificates

Question 8

What does THR stand for?

Answer 8

Traditional Herbal medicinal products

Question 9

What is a manufacture’s license for?

Answer 9

To manufacture, assemble, or import from a state other than an approved country

Question 10

What is a wholesale dealer’s license for?

Answer 10

To sell or supply a medicinal product to a person who is NOT the end user

Question 11

What is Licensed medicine?

Answer 11

A medicine with a UK marketing authorisation which meets acceptable standards of efficacy, safety and quality.

Question 12

What is Unlicensed medicine?

Answer 12

A medicine which does NOT have a UK marketing authorisation

Question 13

What is Off-label medicine?

Answer 13

A licensed medicine that is being used outside of the terms of its marketing authorisation e.g. for an alternative indication

Question 14

What is Pharmacovigilance?

Answer 14

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems (WHO 2006)

Question 15

Who must operate a pharmacovigilance system?

Answer 15

A MA holder

Question 16

Can anyone use the MHRA Yellow Card Scheme reporting site?

Answer 16

Yes they can

Question 17

Is there a dedicated Coronavirus Yellow Card reporting site?

Answer 17

Yes

Question 18

Where can reports be made?

Answer 18

via the Yellow Card Scheme website, the App or via freephone

Question 19

What are the Legal classes?

Answer 19

• POM - Prescription Only Medicine
• P - Pharmacy
• GSL - General Sales List

Question 20

What is the importance of legal classification?

Answer 20

it determines the level of control over the supply

Question 21

What is the importance of classification?

Answer 21

depends in part on how much input is required from a health professional

Question 22

Where can GSL be sold?

Answer 22

From almost any outlet and must be able to close so as to exclude the public

Question 23

Can GSL be sold without pharmacist supervision?

Answer 23

Yes

Question 24

Where can P medicines be sold?

Answer 24

Only from a Pharmacy
Sale made by a pharmacist or under the supervision of a pharmacist
It must be no less safe and effective than if the pharmacist made the sale or supply
position to intervene

Question 25

What does Supervision mean?

Answer 25

no definition of supervision in the HMR
* case law has debated this topic
* supervision in a community pharmacy - should no longer be interpreted to mean a pharmacist supervising individual transactions

Question 26

What is the maximum amount you can supply for Paracetamol tablets?

Answer 26

*

Question 27

What is the maximum amount you can supply for Paracetamol effervescent tablets?

Answer 27

*

Question 28

What is the maximum amount you can supply for Aspirin dispersible tablets?

Answer 28

*

Question 29

What is the maximum amount you can supply for Co-codamol 8/500mg effervescent tablets?

Answer 29

*

Question 30

What is the maximum amount you can supply Co-codamol 8/500mg tablets?

Answer 30

*

Question 31

What is the maximum amount you can supply for Pseudoephedrine tablets?

Answer 31

*

Question 32

What is the maximum amount you can supply for Senna tablets?

Answer 32

*

Question 33

Who can give a POM?

Answer 33

An appropriate practitioner

Question 34

How is a POM given?

Answer 34

On prescription only - legal, complete and appropriate
And under the direct supervision of a pharmacist

Question 35

What does the MHR have to consider?

Answer 35

• The maximum single dose
• The maximum daily dose
• The strength of the product
• Its packaging
• Other relevant considerations

Question 36

What does the HMR Regulations 214 state?

Answer 36

• A person may not sell or supply a POM except by a prescription given by an appropriate practitioner.

Question 37

What is a prescription?

Answer 37

A written order from a qualified medical prescriber to supply a medicine under their authority