The licensing system

Question 1

What are the different types of licences?

Answer 1

• Marketing authorisation
• Manufacturer’s licence
• Wholesale dealer’s licence

Question 2

What are the 2 types of certificates?

Answer 2

• Clinical trials certificate

- Clinical trials exemption certificate

Question 3

Outline the licensing process

Answer 3

Clinical trials ( CTC/CTX) ->

Assemble drug properties/formulation data (MA) ->

Plan to produce in large batches, assemble + pack (ML) ->

Plan to store + distribute product by wholesale (WDL) ->

Marketing + distribution

Question 4

What are the key criteria in licensing a new medicine?

Answer 4

• Safety
• Quality
• Efficacy

Question 5

What is the other name for a marketing authorisation?

Answer 5

Product licence

Question 6

Which products need a marketing authorisation?

Answer 6

All commercially available medicinal products

Question 7

A MA authorises the holder to what?

Answer 7

• Sell, supply + export product
• Procure sale, supply + exportation
• Procure manufacture

Question 8

Is it lawful to supply/manufacture a medicinal product without an MA?

Answer 8

No

Question 9

How long is a MA issued?

Answer 9

5 years

Question 10

After 5 years, MA holders must do what?

Answer 10

Apply for licence renewal

Question 11

Which organisation has power to withdraw or amend a MA?

Answer 11

MHRA

Question 12

What must be submitted in order to obtain a MA for a medicinal product? And to who?

Answer 12

• Info on product

- MHRA

Question 13

What happens when a product is new and must obtain an MA?

Answer 13

• Full info about manufacturing + testing
• Clinical trials result available to MHRA
• Summary of product characteristics submitted

Question 14

What is a manufacturer’s licence?

Answer 14

• Authorises holder to manufacture or assemble medicinal product
• Describes premises, equipment, people, record + qualifications of people involved

Question 15

In a manufacturer’s licence, what does ‘manufacture’ not include?

Answer 15

Doesn’t include dissolving, diluting or mixing

Question 16

Define assemble

Answer 16

Enclosing a product in a container which is labelled before the product is sold or supplied, or re-labelling a product

Question 17

In the manufacturer’s licence, what must the manufacturer comply with?

Answer 17

Principles for good manufacturing practice

Question 18

Who requires a wholesale dealer’s licence?

Answer 18

Any person who sells a medicinal product by way of wholesale dealing

Question 19

What does a wholesale dealer’s licence authorise?

Answer 19

Authorises holder to re-sell to anyone other than the end user

Question 20

Does an MA holder require a wholesale dealer’s licence?

Answer 20

No

Question 21

Outline the requirements for a wholesale dealer’s licence?

Answer 21

• Records for medicines received + dispatched
• Emergency plan for recall of medicines
• MHRA visits to inspect premises

Question 22

Outline the licensing exemptions when importing medicinal products

Answer 22

• Product for administration to importer or member of household
• Product imported by doc/dentist for admin to particular patient

Question 23

Most cases require no license for the export of a product. Which products require a licence?

Answer 23

Biological products:

• Antigens
• Antibodies
• Vaccines

Question 24

Pharmacists don’t require a licence when under the supervision of a pharmacists in a registered pharmacy which consists of…

Answer 24

• Preparing/dispensing product on prescription of practitioner
• Preparing/dispensing product to formula provided by purchaser for administration
• Preparing/dispensing product in course of counter prescribing
• Preparing stock that is not advertised
• Assembling product for retail sale w/o advertisement

Question 25

What are specials?

Answer 25

- Unlicensed products prepared by Special's licence holder - Made on the order of doc, dentist, nurse prescriber, pharmacist prescriber - For patient they're treating

Question 26

What are the requirements of a specials manufacturer?

Answer 26

- Holds specials manufacturer's licence - Not advertise/solicits orders for products - Carry manufacture under certain conditions - Maintain written record

Question 27

How long is a specials record kept at a pharmacy and what must it include?

Answer 27

- 5 years - Patient details - Name + quantity - Who manufactured it - Batch no. - Date supplied

Question 28

Any adverse drug reaction to a special must be reported to who?

Answer 28

MHRA via yellow card scheme

Question 29

Does an unlicensed medicine have an MA?

Answer 29

No

Question 30

Why are extemporaneous medicines classed as specials?

Answer 30

Because they are unlicensed

Question 31

When should unlicensed medicines be prescribed?

Answer 31

If no equivalent licensed product exists

Question 32

What are the requirements when prescribing + dispensing an unlicensed medicine?

Answer 32

- Ensure prescriber realise med is unlicensed + inform prescriber of suitable licensed alternative - Patients informed med is unlicensed

Question 33

What is unlicensed use?

Answer 33

Prescribing of a licensed medicine outside its license

Question 34

What may unlicensed use be due to?

Answer 34

- Dose - Age - Route of admin - Indication

Question 35

What are the requirements when prescribing + dispensing an unlicensed use of product?

Answer 35

- Ensure prescriber is aware of the unlicensed use of a product + inform prescriber of suitable licensed alternative - Patient informed of unlicensed use + what this means

Question 36

Herbal medicines which are for sale to public must have which licenses?

Answer 36

- Licensed as medicine | - Registered under traditional herbal registration scheme

Question 37

What does the traditional herbal registration scheme ensure?

Answer 37

- Quality - Safety - Regulated manufacturing standards - No data required on efficacy - Must provide patient w/ PIL - THR logo + no.