The Licensing System

Question 1

What are the 3 types of licenses?

Answer 1

• Marketing Authorisation (MA)
• Manufacturer’s License (ML)
• Wholesale Dealer’s License (WDL)

Question 2

What are the 2 types of licensing certificates?

Answer 2

• Clinical Trials Certificate (CTC)
• Clinical Trials Exemption Certificate (CTX)

Question 3

True or False: It is illegal to carry out any of the activities without a licence.

Answer 3

True

Question 4

What happens when a MA license is submitted?

Answer 4

Drug data is assembled on the drug properties/formulation.

Question 5

What happens when the ML is submitted?

Answer 5

Produce products in large batches, assemble and packed for sale.

Question 6

What happens when a WDL is submitted?

Answer 6

Store and distribute products by wholesale.

Question 7

What are the 3 key criteria’s when licensing a new medicine?

Answer 7

• Safety
• Quality
• Efficacy

Question 8

True or False: All medicines that are present for patients are 100% safe.

Answer 8

They all have some element of risk. However, that level of risk will only be allowed at a reasonable level.

Question 9

When looking at the efficacy of a new medicine, can you compare it to similar tablets used for a similar treatment?

Answer 9

No, it has to be compared to a placebo.

Question 10

How do you know a product is licensed in the UK?

Answer 10

It has a product license code on the box.

Question 11

Who has the power to amend or suspend a MA?

Answer 11

MHRA

Question 12

What is a quicker way to license a medication?

Answer 12

Ask MHRA to check medicines which are licensed in other countries.

Question 13

What does SmPC stand for and what is it?

Answer 13

Summary of Product Characteristics
-> information of the medicinal products and part of the licensing application
-> assessed and approved by MHRA

Question 14

Why are the 2 main things that you do when having a manufacturer’s license?

Answer 14

• Manufacture
• Assemble

Question 15

True or False: Assembling a medication can include dissolving a product in water to make a suspension.

Answer 15

False

Question 16

Who is responsible for the quality control requirements of a Good Manufacturing Practice?

Answer 16

Qualified Person (QP)

Question 17

True or False: MHRA inspectors can attend a manufacturers licensed premisis once they have contacted them and arranged a date and time.

Answer 17

False, they can attend at any time.
-> They have the right to do anything such as take samples

Question 18

Do pharmacists require a license?

Answer 18

No if the pharmacy does the following:
- dispense a medicinal products on the prescription by a practitioner
- preparing or dispensing a medicinal product to a formula provided by the purchaser for administration to themself or someone in their care
- Counter prescribing (patient HAS to be present)
- Preparing stock of products for above
- Prepare medicinal product for sale from pharmacy (Can’t advertise this)
- Assembling a medicinal product for sale in the pharmacy

Question 19

Licensed medicines have what 2 things?

Answer 19

• Marketing Authorisation
• SmPC

Question 20

Give 2 examples of unlicensed medicines.

Answer 20

• Extemporaneous medicines
• Specials

Question 21

True or False: Vitamins are unlicensed medicines.

Answer 21

True as they are food supplements.
-> Can get some which are licensed

Question 22

What should you do when dispensing an unlicensed medicine?

Answer 22

• Contact the prescriber and make them aware
• Inform them of any suitable licensed alternatives

Question 23

Do patient’s need to be informed is the medicine is unlicensed?

Answer 23

Yes.

Question 24

Any side effects such be recorded on what?

Answer 24

A yellow card to the MHRA.

Question 25

Who are ‘specials’ products produced by?

Answer 25

Special’s license holder

Question 26

What are the 4 things a Specials manufacturer must do?

Answer 26

- Hold a Specials manufacturer’s license - Not advertise the product - Carry out manufacturer under certain conditions to ensure quality of product - Maintain written records

Question 27

How long should a pharmacy keep a record for dispensing ‘specials’?

Answer 27

5 years

Question 28

What is an off-label medicine?

Answer 28

Licensed medicine used outside of what is stated on the SmPC.

Question 29

Give some examples of how a medicine may be off-label.

Answer 29

- Dose (high/low, or frequency) - Age - Route of Administration - Indication

Question 30

Can a manufacturer take responsibility for a medicine which is not used according to the SmPC?

Answer 30

No as doesn’t follow licensed use.

Question 31

Who is responsible if a patient suffers adverse effects from medicines which are off-label?

Answer 31

The prescriber and the pharmacist.

Question 32

True or False: Tablets which are crushed are still licensed.

Answer 32

False. It is unlicensed as the manufacture had made it for the tablet to be swallowed whole.

Question 33

What is a parallel imported medicine?

Answer 33

- Medicines imported from another country (approved country) - Version of the same medicine which is available in the UK with a UK marketing authorisation

Question 34

What is the benefit of Parallel imported medicines?

Answer 34

Cheaper than those in the UK.

Question 35

Does a parallel imported medicine require a MA?

Answer 35

Yes but don’t need a full one.

Question 36

Do PIs need to be relabelled?

Answer 36

Yes as they will be in a different language.

Question 37

How do you know if a PI is not dodgy?

Answer 37

Look for a PL (PI) number on the English label.

Question 38

If a prescription includes a product with the brand name of the UK, can a PI be dispensed?

Answer 38

No, only that product.

Question 39

What is a herbal medicine?

Answer 39

Medicinal product whose active ingredients are from a plant.

Question 40

Do herbal medicines require a license?

Answer 40

Yes for either of the following: - Licensed as a medicine - Registered under the Traditional Herbal Registration (THR)

Question 41

True or False: Herbal medicines follow the safety, quality and efficacy of the manufacturing standards.

Answer 41

False. Only safety and quality as the efficacy follows traditional use.

Question 42

True or False: A THR logo and a THR number are needed on the packaging of a herbal medicine.

Answer 42

False, only the THR number.