Wk 26 - Licensing

Question 1

What are the types of license?

Answer 1

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

Question 2

Outline the licensing process

Answer 2

• Clinical trials in patients suffering disease
• Assemble data about drug (MA)
• Plan to prod large batches, assemble + pack (ML)
• Plan to store + distribute product by wholesale (WDL)
• Market + distribution

Question 3

What are the key criteria in licensing a new medicine?

Answer 3

• Safety
• Quality
• Efficacy

Question 4

Which organisation give authority to license a product?

Answer 4

MHRA

Question 5

How long til you have to reapply for an MA license?

Answer 5

5 yrs

Question 6

When would a product be defined as a generic medicinal product?

Answer 6

• Same qualitative + quantitative composition in active substance
• Same form
• Bioequivalence w/ RMP demonstrated

Question 7

How long is the data exclusivity period?

Answer 7

8 years

Question 8

When can a biosimilar be marketed?

Answer 8

After patent of OG biologic has expired

Question 9

Which group of medicines needed to be prescribed by brand name?

Answer 9

Biologics + biosimilars

Question 10

What must herbal medicines be registered under?

Answer 10

THR scheme

Question 11

What is the THR scheme?

Answer 11

• Quality + safety
• THR logo + no.

Question 12

What is pharmacovigilance?

Answer 12

• Post marketing surveillance of the safety of medicines
• Focused on black triangle meds

Question 13

What does it mean if a medicine has a black triangle?

Answer 13

• Contains active substance
• Biological med: vaccine
• Conditional approval
• Approved under exceptional circumstances

Question 14

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

Answer 14

No

Question 15

Give examples of licensing exemptions

Answer 15

• Imported by doctor/dentist for admin to a particular patient
• Manufactured or assembled by doctor or dentist for particular patient
• Assembled by nurse or midwife
• Mixing as part of CMP

Registered pharmacy:

• Dispensing prod on prescription
• Dispensing OTC
• Wholesale dealing

Question 16

What is the difference between unlicensed product + unlicensed use?

Answer 16

• Prod: no MA
• Use: not usual indication

Question 17

What is required in order to prepare specials?

Answer 17

• Manufacturers license
• Don’t advertise
• Carry out under certain conditions
• Written records

Question 18

When dispensing a specials product, how long must the record be kept + what should be included?

Answer 18

5 years: patient details, name + quantity of product, who manufactured, batch no. + date supplied to patient

Question 19

What are the reasons a product may be considered unlicensed?

Answer 19

• Dose
• Age
• Route
• Indication
• Crushing

Question 20

What is a parallel imported medicine?

Answer 20

Med imported from another country where a version is already available in UK + has UK marketing authorisation

Question 21

What are counterfeit medicines?

Answer 21

• Med deliberately + fraudulently mislabeled w/ respect to identity or source