Regulation of medicines

Question 1

What is the definition of a medicinal product?

Answer 1

Any substance or combination of substances presented as having properties of preventing or treating disease in humans or may be administered with a view to correcting or modifying pharmacological function

Question 2

What is meant by an authorised medicinal product?

Answer 2

One that has:

a) marketing authorisation - meds
b) cert of registration - homeopathics
c) traditional herbal reg - herbal remedies

Question 3

A borderline substance is one that contains a pharmacological active substance. True or false?

Answer 3

False - regarded as medicinal if it does.

A borderline substance is one that is not easy to distinguish from a medicine e.g. food supplement/cosmetics

Question 4

Medical devices are covered by human medicines regulations 2012. True or false?

Answer 4

False - covered by Medical devices regs 2002

Question 5

Sutures and dressings are regarded medical devices. True or false?

Answer 5

True

Question 6

It is recommended that medical devices have CE mark on. True or false?

Answer 6

False - mandatory

Question 7

CE mark is regarded equivalent to a marketing authorisation. True or false?

Answer 7

True

Question 8

CE mark shows that the manufacturer claims the product is safe and fit for its intended purpose. True or false?

Answer 8

True

Question 9

Phase 1 of clinical trials involves giving the drug to a large group of people. True or false?

Answer 9

False - giving to a small number of people for the first time

Question 10

Phase 2 of clinical trials is to see if the drug is effective and to further evaluate its safety. True or false?

Answer 10

True

Question 11

Phase 3 of clinical trials involves giving the drug to 1000-3000 people to confirm effectiveness. True or false?

Answer 11

True

Question 12

Phase 4 of clinical trials involves pre-marketing studies. True or false?

Answer 12

False - post marketing studies

Question 13

All relevant medicinal products must have MAs. True or false?

Answer 13

True

Question 14

Products on the market prior to licensing requirements of the Medicines Act were granted a Product licence of right. True or false?

Answer 14

True

Question 15

Biological and biotechnology products are a type of application for MA. True or false?

Answer 15

True

Question 16

MAs are initially granted for a period of 3 years. True or false?

Answer 16

False - 5 years

Question 17

MAs must be renewed on expiry, True or false?

Answer 17

True

Question 18

MA holder must keep licencing authority updated on proposed changes in the product or procedures and fresh information affecting validity of data on which licence was granted. True or false?

Answer 18

True

Question 19

The European Medicines Agency is the UK’s medicines licencing authority. True or false?

Answer 19

False - the MHRA is

Question 20

MA holders are advised to keep records of any adverse reports, all sales/supplies, sources of all materials and produce a periodic safety update report. True or false?

Answer 20

False - they must keep records

Question 21

MHRA doesn’t have the right to reject product names used in MA. True or false?

Answer 21

False - can reject any name if it considers that name will cause confusion, is misleading or is otherwise unsafe

Question 22

There is a requirement for paediatric data based on a paediatric investigation plan (PIP). True or false?

Answer 22

True

Question 23

For paeds, the category of MA is Paediatric Use Marketing Authorisation. True or false?

Answer 23

True

Question 24

Buccolam (buccal midazolam) was the first ever children’s medicine to hold PUMA. True or false?

Answer 24

True