Licensing System

Question 1

What do licenses and certificates permit?

Answer 1

Permit a person or company to engage in specific, controlled activities e.g. efficacy, safety and quality

Question 2

Marketing Authorisation (MA) is granted by the MHRA to authorised what?

Answer 2

• Sell, supply and export product
• Procure its sale, supply and exportation
• Procure its manufacture

Question 3

How often does MA need renewed?

Answer 3

every 5 years

Question 4

What must medicinal products have?

Answer 4

An MA

Question 5

What is an ML and what does it authorise?

Answer 5

Manufacturers License
- Authorises manufacture and assembly of medicinal product.

Question 6

What is a WDL and what does it authorise?

Answer 6

Wholesale dealer’s license
- Authorise re-selling of a medicinal products by wholesale dealing.

Question 7

What are the licensing exemptions for pharmacist/ those under their suspension?

Answer 7

• Dispensing medicines on Rx
• Dispensing medicines in the course of counter prescribing
• Preparing a product to a formula provided by purchaser for admin
• Preparing a stock of products for use
• Preparing a stock medicines for sale from pharmacy
• Assembling a medicine for retail sale without advertisement from the pharmacy

Question 8

What is a special?

Answer 8

Unlicensed products prepared by a special’s license holder ordered by an appropriate prescriber for a patient

Question 9

How long do you keep the records for a special?

Answer 9

5 years

Question 10

What are the requirements for a special?

Answer 10

• Patient name
• Drug name and quantity
• Batch No.
• Date of supply

Question 11

Who do you report adverse reactions to and how?

Answer 11

MHRA via yellow card scheme

Question 12

How do you know if a medicine is unlicensed? Name two examples of unlicensed medicines.

Answer 12

• They have no MA/Summary Of Product Characteristics (SPC)
• Extemporaneous and specials

Question 13

What would you do in the case of unlicensed medicines?

Answer 13

• Unlicensed use due to dose, age, indication, form
• Pharmacists should inform prescriber it is unlicensed and suggest alt if there is one
• Inform patient it is unlicensed and what this means

Question 14

What is off-label use?

Answer 14

Prescribing licensed medicines outside of their license

Question 15

What are you required to do in the case of off-label use?

Answer 15

Inform prescriber and patient of unlicensed use

Question 16

What are parallel imports?

Answer 16

Medicines imported from another member state of the EU

Question 17

True or False, Parallel imports are cheaper than UK imports?

Answer 17

TRUE

Question 18

What are the requirements of Parallel imports?

Answer 18

• Must be branded version of UK product with an MA from the country of manufacture.
• Must be labelled in english and english PK
• Prescribe exact brand on Rx
• Can apply for shortened application for a product license - PL rather than full MA

Question 19

What must be licensed under the THR scheme?

Answer 19

Herbal medicines

Question 20

What does THR stand for?

Answer 20

Traditional herbal registration

Question 21

What does the THR scheme do?

Answer 21

Quality, safety, THR logo/no, regulated manufacturing standards, no data required an efficacy